CURRICULUM VITAE
`OREGON HEALTH AND SCIENCE UNIVERSITY
`Name: Eric Roeland, MD, FASCO, FAAHPM Date Prepared: January 30, 2026
`Phonetic Spelling: “ERR-ik” “r-OH-L-ahn-d” Pronouns: he / him / his / él
`I. PRESENT
`POSITION AND ADDRESS
`Ass
`ociate Professor
`Oregon Health and Science University
`Department of Medicine
`Division of Hematology/Oncology
`Division of Oncological Sciences
`Medical Oncology and Palliative Care
`Knight Cancer Institute
`Director, Symptom Science Research
`Orego
`n Health and Science University
`Knight Cancer Institute
`Division of Hematology and Medical Oncology
`3181 SW Sam Jackson Park Road, OC14HO
`Portland, OR 97239
`E-mail: roeland@ohsu.edu
`II. EDUCATI
`ON
`Undergraduate and Graduate
`09/96 - 06/00 BA Spanish Language and Literature Northwestern University
`06/01 - 06/05 MD Medicine University of Colorado Health Sciences
`Center
`Pos
`t-Doctoral Training
`07/05 - 06/06 Intern Internal Medicine University of California San Diego
`07/06 - 06/08 Resident Internal Medicine University of California San Diego
`07/08 - 06/09 Fellow Hospice and Palliative Medicine San Diego Hospice and
`The Institute for Palliative Medicine
`07/09 - 06/12 Fellow Hematology and Oncology University of California San Diego
`III. CERTIFICA
`TIONS AND LICENSES
`Certifications
`08/08 - 12/18 Diplomate, Internal Medicine American Board of Internal Medicine (ABIM)
`01/10 - Diplomate, Hospice and Palliative Medicine ABIM Certified, Participating in
`Maintenance of Certification
`01/13 - Diplomate, Medical Oncology ABIM Certified, Participating in
`Maintenance of Certification
`HELSINN EXHIBIT 2087
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00947
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`OHSU CV [Eric Roeland, MD]
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`Active and Past Licenses
`
`01/07 - 12/18 Past California Medical License 98796
`03/08 - 04/27 Active DEA, Schedule II-VI Available upon request
`03/18 - 12/22 Past Massachusetts Medical
`License
`273842
`07/21 - 12/27 Active Oregon Medical License 205107
`01/23 - 01/25 Past Basic Life Support American Heart Association
`09/23 - 12/25 Past Washington Medical
`License
`61413587
`
`Formal Faculty Development
`
`2014 - 2015 National Center of
`Leadership in Academic
`Medicine
`UC San Diego This program focused on junior faculty to
`develop skills for an academic career,
`implement a strategic plan, and network
`across the university.
`2015 Supportive Oncology
`Workshop
`Massachusetts General
`Hospital
`I was selected as a participant in a week-
`long mentored workshop on protocol
`development.
`2015 Vail Workshop Methods
`in Clinical Cancer
`Research
`American Society of
`Clinical Oncology /
`American Association for
`Cancer Research
`This mentored week-long workshop
`focuses on developing a clinical trial
`protocol.
`2017 Advanced Certificate in
`Clinical Research
`UC San Diego Extension
`Clinical Research
`Enhancement through
`Supplemental Training
`This program focuses on training in
`research methods, application of these
`methods, and effective clinical research
`collaboration (20 units).
`2018 - 2019 Education Scholar
`Program
`American Society of
`Clinical Oncology
`I was selected as a participant in the
`inaugural class of this ASCO international
`education and leadership program.
`2023 - 2024 Oncology Educational
`Fellowship
`Food and Drug
`Administration and
`American Association for
`Cancer Research
`This year-long program focused on drug
`development and regulatory review,
`including an in-person mock Oncology
`Drug Advisory Committee (ODAC)
`meeting at the FDA White Oak Campus.
`2025 - 2026 Mid-Career Clinical
`Leadership
`Development Program
`Oregon Health and
`Science University
`This year-long program enhances
`leadership skills for mid-career faculty by
`developing essential competencies,
`understanding leadership styles, and
`navigating the OHSU system effectively.
`
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`OHSU CV [Eric Roeland, MD]
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`IV. PROFESSIONAL EXPERIENCE
`
`Academic Appointments
`
`07/12 - 04/18 Assistant Professor Medicine
`Hematology/Oncology
`University of California San Diego
`Moores Cancer Center
`05/18 - 04/21 Assistant Professor Medicine
`Hematology/Oncology
`Harvard Medical School
`Massachusetts General Hospital
`05/21 - 06/23 Assistant Professor Medicine
`Hematology/Oncology
`Oregon Health and Science University
`Knight Cancer Institute
`07/23 - Associate Professor Medicine
`Hematology/Oncology
`Oregon Health and Science University
`Knight Cancer Institute
`
`Administrative
`
`06/12 - 07/18 Co-Leader Palliative Care University of California San Diego
`Moores Cancer Center
`06/12 - 07/18 Director Symptom Management
`Research
`University of California San Diego
`Moores Cancer Center
`07/21 - 05/22 Program Director Melanoma Oregon Health and Science University
`Knight Cancer Institute
`07/21 - Program Director Symptom Science Oregon Health and Science University
`Knight Cancer Institute
`07/25 - Program Director Melanoma Oregon Health and Science University
`Knight Cancer Institute
`
`Hospital / Clinical / Professional Appointments
`
`07/12 - 04/18 Assistant Clinical
`Professor
`Internal Medicine
`Hematology/Oncology
`University of California San Diego
`05/18 - 04/21 Assistant in Medicine Internal Medicine
`Hematology/Oncology
`Massachusetts General Hospital
`05/21 - 07/23 Assistant Professor Internal Medicine
`Hematology/Oncology
`Oregon Health and Science University
`07/23 - Associate Professor Internal Medicine
`Hematology/Oncology
`Oregon Health and Science University
`
`Other Professional Positions
`
`2014 - 2016 Member Data Safety Committee Cellceutix Corporation
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`OHSU CV [Eric Roeland, MD]
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`2016 - 2017 Expert Witness Alexander v. Scripps
`Memorial Hospital
`(Defendant)
`Higgs, Fletcher & Mack
`Superior Court of California
`Count of San Diego Central Division
`Case No. 37-2014-00016257-CU-MM-CTL
`2016 - 2020 Member Data Safety Committee Galera Therapeutics
`2017 - 2018 Member Oncology Advisory Panel,
`Clinical Guidelines
`American Imaging Management
`Specialty Health
`2017 - Member Scientific Advisory Board Napo Therapeutics (NCT04538625)
`03/19 - Pre IND meeting
`05/25 - FDA Type C Meeting
`2019 - 2020 Member Data Safety Committee Oragenics
`2020 - 2021 Chair Data Safety Committee Enzychem Lifesciences
`2020 - 2021 Expert Witness Chappell ex rel Estate of
`Chappell v. UCLA Medical
`Center (Defendant)
`Fraser Watson & Croutch
`Superior Court of the State of California
`County of Los Angeles
`Case No. 19STCV01304 9
`2021 - Member Scientific Advisory Board Agilix
`2021 - Member Scientific Advisory Board Actimed Therapeutics
`2022 - Member Scientific Advisory Board Meter Health
`2022 - Member Executive Steering
`Committee
`Pfizer (NCT05546476) Phase II study of
`ponsegromab in patients with NSCLC,
`pancreatic, and colorectal cancer and
`cachexia
`2023 - 2024 Expert Witness Heron Therapeutics, Inc
`(Plaintiff) v. Fresenius Kabi
`USA, LLC
`Paul Hastings
`District of Delaware
`Case No. 22-985-WCB
`2024 - Expert Witness Heron Therapeutics, Inc
`(Plaintiff) v. Mylan
`Pharmaceuticals, Inc
`Paul Hastings
`District of Delaware
`Case No. 23-1015-WCB
`2025 - Chair Executive Steering
`Committee
`Pfizer (NCT06989437) Phase II/III study
`of ponsegromab in patients with
`pancreatic cancer and cachexia
`2025 - Expert Witness Heron Therapeutics, Inc
`(Plaintiff) v. Azurity
`Pharmaceuticals, Inc
`Paul Hastings
`District of Delaware
`Case No. 24-830-WCB
`Case No. 24-1363-WCB
`
`V. CONTRIBUTIONS TO DIVERSITY, EQUITY, INCLUSION, AND BELONGING
`
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`OHSU CV [Eric Roeland, MD]
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`2015, 2016,
`2017, 2018,
`2020, 2024
`Foro Internacional de
`Medicina del Dolor y
`Paliativa
`
`Instituto Nacional de
`Ciencias Médicas y
`Nutrición
`Salvador Zubrián
`Universidad Nacional
`Autónoma de México
`As a returning invited faculty member,
`I teach palliative care-focused topics in
`English and Spanish to the pain and
`oncology faculty, trainees, and
`community clinicians at one of
`Mexico's few national palliative care
`training programs.
`2021 - American Society of
`Clinical Oncology
`International Educator for
`India and Indonesia
`I am an active member of the ASCO
`International Education Committee. I
`also serve as a faculty educator for
`ongoing virtual courses focused on
`resource-limited settings and patients
`with the highest needs. I have
`facilitated discussions on palliative
`care topics, including optimal symptom
`management, communication,
`prognostication, and end-of-life care.
`2022 - Co-mentor
`PI Tibbitts
`Investigating sex and
`gender-related
`differences in
`immunotherapy
`treatment effects
`(NCT06562777)
`Building Interdisciplinary
`Research Careers in
`Women’s Health
`(BIRCWH)
`NIH/NIAMS
`8K12AR084221
`I serve as a co-mentor and research
`collaborator on Dr. Tibbitts’s career
`development award, a prospective
`observational study comparing the
`incidence and severity of
`immunotherapy-related adverse
`events (irAEs) between self-identified
`sex/gender.
`
`VI. SCHOLARSHIP
`
`Area of Research Interest/Scholarly Interest
`
`Symptom Science and Clinical Intervention: My clinical research interest and expertise focus on optimizing
`symptom management for people living with cancer. My significant scholarly activities and achievements center
`on identifying, validating, and expanding the number of pharmacologic interventions to minimize treatment-
`related toxicity and optimize quality of life. My research interests include cancer cachexia, immunotherapy-
`related adverse events (irAEs), chemotherapy-induced peripheral neuropathy (CIPN), and chemotherapy-
`induced nausea and vomiting (CINV).
`
`Keywords: symptom science, oncology, drug development, palliative care, cancer cachexia, nausea/vomiting,
`neuropathy
`
`Grants and Contracts
`
`Total current grants awarded as Principal Investigator (PI) or Co-Principal Investigator (Co-PI)
`Federal 8 Total as PI/Co-PI 4 Total dollar award $6,190,228
`State and Local 21 Total as PI/Co-PI 21 Total dollar award ~$1,500,000
`Industry 15 Total as PI/Co-PI 15 Start-up
`Per-patient
`$303,943
`$228,909
`Grants 4 Total as PI/Co-PI 4 Total dollar award $603,876
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`OHSU CV [Eric Roeland, MD]
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`Foundations 3 Total as PI/Co-PI 3 Total dollar award $1,104,000
`Total grants awarded as Principal Investigator (PI)
`Federal 2 Total as PI 2 Total dollar award
`State and Local 21
`Industry 15 Total as PI 15 Start-up
`Per-patient
`$303,943
`$228,909
`Grants 3 Total as PI 3 Total dollar award $360,000
`Foundations 2 Total as PI 2 Total dollar award $210,000
`Publications originating from grants and contracts
`Total (n) 12 In-Rank (n) (07/23) 1 First/senior author (n) 6
`
`Federal
`
`Current
`2020 - 2025
`
`PATTERN: Patterns and predictors of symptoms, falls, and functioning across treatment and
`recovery in patients treated with neurotoxic chemotherapy for cancer
`Sponsor: NIH/NCI (NCT05790538)
`Division of Cancer Prevention 1R01CA226082-01A1
`Co-I (PI: Winters-Stone; 0.6 person months per year, $3,139,032)
`This study aims to characterize the trajectories of neuropathy symptoms and functioning
`(objective mobility, physical activity, self -reported functioning, and disability) after receipt of
`neurotoxic chemotherapy. Additionally, we will determine the simplest patient -centered
`predictors of symptom and functional trajectories to identify patients who would benefit most
`from early, targeted interventions. The knowledge gained from this study will identify high -risk
`patients who may benefit from neurotoxic chemotherapy adjustments and early targeted
`rehabilitation. We published the protocol in BMC Cancer in 2023 (PMID: 37946117).
`2023 - 2028
`
`The Pacific Aging and Cancer Studies (PACS): An Infrastructure Advancing the Use of Digital
`Biomarkers and Related Technologies for Research on Functional Aging and Survivorship in Cancer
`Sponsor: NIH/NCI
`P30 Supplement CA069533-22S6
`Co-I (PI: Winters-Stone; $2,731,196)
`This project aims to assess the feasibility of implementing a continuous, passive monitoring
`platform to describe changes in digital biomarkers of toxicity and symptom trajectories (mobility,
`cognitive function, sleep, pain, depression) between older and younger patients receiving cancer
`treatment. We published our findings in patients with hematologic malignancy undergoing
`autologous hematopoietic stem cell transplantation in JMIR Cancer in 2022 (PMID: 36480243).
`
`Completed
`2022 - 2024
`
`SWOG S2013: Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational
`Study Sponsor: NCI/NCTN (NCT04871542)
`Site PI (PI: Gunturu; per patient $3,000)
`This SWOG-sponsored NCTN study focuses on developing and validating a risk prediction model
`for grade 3 or high non-hematological immune-related adverse events (irAEs) in the first year of
`immune checkpoint inhibitor-based therapy for treating solid tumors. Additionally, a translational
`aim is to develop a cytokine toxicity score derived from 11 cytokine levels as a predictive signature
`for the development of irAEs.
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`OHSU CV [Eric Roeland, MD]
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`2015 Alliance A221301: Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting
`in Patients Receiving Highly Emetogenic Chemotherapy (HEC): A Randomized, Double -Blind,
`Placebo-Controlled Trial
`Sponsor: NCI/NCTN (NCT02116530)
`Site PI (PI: Navari; per patient $2,500)
`Olanzapine is a second -generation antipsychotic with dopamine and serotonin ( D2, 5HT2A,
`5HT2C, and 5HT3) neurotransmitter activity, including receptors in the nausea/vomiting pathway.
`This study evaluated the combination of olanzapine vs placebo with standard chemotherapy -
`induced nausea and vomiting (CINV) prophylaxis in patients receiving highly emetogenic
`chemotherapy. Results demonstrated that adding olanzapine improved CINV complete response
`without severe side effects ( New England Journal of Medicine, 2016). Olanzapine is now part of
`all evidence-based guidelines for CINV prophylaxis.
`2015 SWOG S1013: Prospective Study of Epidermal Growth Factor Receptor (HER -1/EGFR) Inhibitor-
`Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer-Therapy-EGFRI
`18 (FACT-EGFRI 18) Questionnaire for EGFRI-Induced Skin Toxicities
`Sponsor: NCI/NCTN (NCT01416688)
`Site PI (PI: Baker; per patient $1,000)
`This study validated a questionnaire to assess therapy complications, including psychosocial and
`quality-of-life assessment in patients receiving epithelial growth factor receptor-targeted therapy
`with skin toxicity (Journal of Patient-Reported Outcomes 2020).
`2015 - 2016
`
`A Prospective Pilot Study to Evaluate and Correlate Early Lean Muscle Loss with Functional Activity
`in Metastatic Gastrointestinal and Lung Cancer Patients
`Sponsor: NCI/NCTN
`Alliance Cancer Control Program Junior Faculty Award #UG1CA189823
`PI ($200,000)
`This grant supported a prospective, observational study correlating body composition changes per
`cross-sectional computed tomography (CT) with anthropometric, functional, and patient-reported
`outcomes (Supportive Care in Cancer 2021, PMID: 32990784, first author).
`2015 - 2018 Alliance AA221203: Early Palliative Care in Metastatic Gastrointestinal and Lung Cancer Patients
`Sponsor: NCI/NCTN (NCT01401907)
`Site PI (PI: Temel; per patient $2,500)
`Following the groundbreaking palliative care study published in the New England Journal of
`Medicine in 2010, the Alliance proposed a multicenter study evaluating the integration of
`palliative care within 8 weeks of a metastatic gastrointestinal or incurable lung cancer diagnosis.
`The University of California San Diego was selected as one of 10 academic sites, and we enrolled
`25 patients in the study. Overall, this study demonstrated improved quality of life but had high
`degrees of missing data, highlighting the challenges of enrolling patients in supportive care tria ls
`through an NCTN mechanism (Journal of Palliative Medicine 2020, PMID: 32031887).
`2017 - 2018
`
`Cancer Clinical Investigator Team Leadership Award
`Sponsor: NCI
`PI ($120,000)
`This grant recognizes and supports outstanding mid-career clinical investigators at NCI-designated
`cancer centers who improve the lives of people living with cancer through extensive involvement
`in NCI-funded collaborative clinical trials and whose leadership, participation, and activities
`promote clinical trials and research. The award provided 15% effort to continue active
`engagement in symptom interventional clinical trials. Cancer Center Directors nominate each
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`OHSU CV [Eric Roeland, MD]
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`recipient based on their qualifications, interests, accomplishments, and the nominee’s ability to
`pursue an academic career in clinical research.
`
`National Foundations
`
`2025 -
`
`Taking Aim at the Achilles’ Heel: Leveraging the Study of Off-Target Immune Toxicities to Improve
`the Treatment of Patients on Immune Checkpoint Inhibitor Therapy for Cancer.
`Sponsor: Kuni Foundation
`Co-I (Co-PIs: Molly Thomas, MD, PhD, and Deanne Tibbitts; $100,000)
`The blockade of immune checkpoints (PD -1 and CTLA-4) has advanced oncology but is hindered
`by immune-related adverse events (irAEs), particularly colitis (irColitis). This project hypothesizes
`that baseline patient factors and CD8+ T cell states can predict irColitis risk. Objectives include: (1)
`Defining a retrospective irColitis cohort using large language models to identify risk factors; (2)
`Investigating CD8 T RM cell signatures in tissue as predictors; and (3) Establishing a prospective
`cohort to assess blood CD8 T cell features related to irColitis risk.
`Completed
`2012 - 2014 Single-Center, Prospective Feasibility Study Evaluating a Novel Approach to Advance Care
`Planning in an Outpatient Academic Palliative Care Clinic
`American Cancer Society
`University of California San Diego Pilot Grant
`Principal Investigator ($30,000)
`This study evaluated a novel , practical social worker- led advance care planning intervention,
`assessing the concordance between end-of-life care wishes and actual events. This pilot study
`(n=34) suggests a focused intervention was feasible and may be sufficient to inform a proxy and
`achieve end -of-life preferences ( Journal of Palliative Medicine 2016, PMID: 26826962, Last
`Author).
`2013 - 2018 Positive Outcomes in Cancer Care: Emphasizing Quality of Life and Legacy
`American Cancer Society
`124667-MRSG-13-233-01-PCSM
`Co-Investigator (PI: Montross; $714,000)
`Dignity therapy is a psychotherapeutic intervention that helps patients with terminal illnesses
`review the people and events most meaningful to them and document their legacy to improve
`the end -of-life experience. I was a Co-I and site PI for this grant, assisting with patient
`identification and recruitment in our academic palliative care clinic. We successfully referred and
`enrolled over 50 patients in this study, published in BMC Palliative Care [PMID: 26391775].
`2016 - 2019 Sojourns Scholar Leadership Program
`Cambia Health Foundation
`Principal Investigator ($180,000)
`This grant’s focus is to identify, cultivate, and advance the next generation of palliative care
`leaders. This program includes multidisciplinary palliative care clinicians and other emerging
`health system leaders by investing in their professional development. As a Sojourns Scholar, I
`received funding over two years to protect time for critical leadership skill development and to
`conduct a prospective observational study of patients with metastatic cancer experiencing
`weight loss. The project aimed to refine cancer cachexia clinical trial methodology, which we
`published in Supportive Care in Cancer (2021) [PMID: 32990784, first author].
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`OHSU CV [Eric Roeland, MD]
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`2018 - 2020 Key Outcomes in Palliative Care Chaplaincy
`Sponsor: Cambia Health Foundation
`Co-I, Co-mentor (PI: Kestenbaum, $180,000)
`I mentored a palliative care chaplain in developing a longitudinal database of patient -centered
`chaplaincy outcomes in palliative care at an academic palliative care clinic. This dataset was used
`to obtain funding from the Cambia Health Foundation. Allison Kestenbaum, BCC -PCHAC, ACPE,
`was named the first chaplain recipient of the Sojourns Scholar Leader Award, and we published
`early findings in the Journal of Health Care Chaplaincy [PMID: 34866556, Last Author].
`
`State and Local: Industry
`
`Current
`2023 - 2025 Study of the Efficacy and Safety of Ponsegromab in Patients with Cancer, Cachexia, and Elevated
`GDF-15 (PROACC-1)
`Sponsor: Pfizer (NCT05546476)
`Executive Steering Committee Member / Site PI (Start-up $20,000, per patient $55,991)
`This phase II RCT evaluated the efficacy, safety, and tolerability of ponsegromab, an inhibitor of
`GDF-15, compared to placebo in patients with cancer, cachexia, and elevated growth
`differentiation factor -15 (GDF-15). Patients with advanced cancer and elevated concentrations of
`GDF-15 frequently develop cachexia, which impacts their quality of life and survival. Inhibiting the
`activity of GDF-15 in such patients may help reverse cachexia and improve their quality of life. We
`were the highest-enrolling site in North America, and the results were presented at the European
`Society of Medical Oncology in September 2024 , with simultaneous publication in the New
`England Journal of Medicine (PMID: 39282907).
`2025 - A Low-Interventional Study to Assess GDF-15 Levels in Adult Participants with Cachexia and
`Malignant Solid Tumors
`Sponsor: Pfizer
`Executive Steering Committee Member / Site PI (Start-up $10,000, per patient $1,749)
`This low-interventional study aims to measure growth differentiation factor-15 (GDF-15) levels in
`adults with cachexia and malignant solid tumors in a real -world setting. By enrolling patients
`across institutions, the study seeks to characterize GDF -15 in individuals with malignant solid
`tumors, excluding non -small cell lung cancer, pancreatic cancer, and colorectal cancer. The
`findings may inform the management of patients living with cancer and elevated GDF -15 levels,
`potentially leading to a significant global impact.
`2025 - A Phase 1B Dose-Escalation Study of AV-380 in Combination with Standard-of-Care Chemotherapy
`in Metastatic Cancer Patients with Cachexia and Elevated GDF-15 Levels
`Sponsor: Aveo Pharmaceuticals (NCT05865535)
`National PI / Site PI (Start-up $pending, per patient $pending)
`This open-label ascending dose study aims to assess the safety, pharmacokinetics,
`pharmacodynamics, and immunogenicity of AV-380 in patients with metastatic solid tumor
`cancers experiencing cachexia. AV-380 is an intravenous IgG1 monoclonal antibody designed to
`bind to circulating human growth differentiation factor 15 (GDF-15), a cytokine implicated in
`cancer-related cachexia.
`
`Completed
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`OHSU CV [Eric Roeland, MD]
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`2012 - 2013 Randomized Phase II Placebo -Controlled Study of LY2495655 in Patients with Advanced or
`Metastatic Pancreatic Cancer Receiving Chemotherapy
`Sponsor: Eli Lilly (NCT01505530)
`Site PI (Start-up $17,024; per patient $19,087)
`Anti-myostatin antibodies have shown activity in preclinical models of skeletal muscle wasting ,
`including cancer cachexia. LY2495655 is a humanized monoclonal antibody to myostatin, a key
`regulator of skeletal muscle development. This trial failed to accrue patients due to restrictive
`inclusion criteria requiring >5% weight loss over the preceding 6 months . Data did not
`demonstrate any benefit in patients with pancreatic cancer. My experiences with this study made
`me question existing prospective clinical methods for evaluating novel pharmacologic approaches
`in treating patients with cancer cachexia (Journal Cachexia Sarcopenia Muscle 2018).
`2012 - 2015 Phase I Safety Study of LY2787106 in Patients with Cancer and Anemia
`Sponsor: Eli Lilly (NCT01340976)
`Site PI (Start-up $11,020; per patient $20,319)
`Hepcidin plays a central role in iron homeostasis and erythropoiesis. Neutralizing hepcidin with a
`monoclonal antibody may prevent ferroportin internalization, restore cell iron efflux, and allow
`transferrin-mediated iron transport to the bone marrow. This multicenter phase I study evaluated
`the safety, pharmacokinetics, pharmacodynamics, and efficacy of a fully humanized monoclonal
`antibody (LY2787106) targeting hepcidin in patients with cancer and anemia. We enrolled 36%
`(12 of 33) total patients, presented our findings at the American Society of Hematology 2015
`Annual Meeting, and published in the Journal of Hematology and Oncology in 2017 (PMID:
`28327200, Senior Author).
`2012 - 2017 Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of V212 in
`Adult Patients with Solid Tumor or Hematologic Malignancy
`Sponsor: Merck (NCT01254630)
`Site PI (Start-up $14,720; per patient $9,086)
`Herpes zoster is a common and extremely painful event for patients with cancer. Previous FDA-
`approved vaccines were contraindicated in patients receiving chemotherapy. This large
`international study (n=5,286) evaluated a third -generation, gamma -irradiated herpes zoster
`vaccine for patients with cancer receiving chemotherapy . Results demonstrated that the
`inactivated varicella-zoster virus ( VZV) vaccine was well tolerated and efficacious in preventing
`VZV in patients with solid tumor cancers receiving chemotherapy [PMID: 31399378].
`2013 Anamorelin HcL in the Treatment of Non -Small Cell Lung Cancer Cachexia (NSCLC -C): A
`Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study to Evaluate the Safety
`and Efficacy of Anamorelin HcL in Patients with NSCLC-C (ROMANA 1)
`Sponsor: Helsinn Healthcare SA (NCT01387269)
`Site PI (Start-up $13,670; per patient $11,395)
`Preclinical and early-phase clinical trials demonstrated improved lean body mass in patients with
`cancer cachexia receiving anamorelin, an oral ghrelin analog. This international RCT demonstrated
`that anamorelin significantly increased lean body mass but did not improve handgrip strength
`(Lancet Oncology 2016). My experiences with this trial catalyzed my interest in evaluating and
`validating prospective methodologies for cancer cachexia clinical trials to inform clinically
`meaningful endpoints for regulatory approval.
`2013 Anamorelin HcL in the Treatment of Non -Small Cell Lung Cancer Cachexia: An Extension Study
`(ROMANA 3)
`Sponsor: Helsinn Healthcare SA (NCT01395914)
`Site PI (Start-up $19,920; per patient $6,676)
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`OHSU CV [Eric Roeland, MD]
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`This study was an extension study of two phase II , double-blind studies to assess the safety and
`efficacy of anamorelin in patients with advanced non-small cell lung cancer ( NSCLC)-associated
`cachexia. Treatment-related adverse events were similar in the treatment arm compared to the
`placebo without any change in regulatory approval (Annals of Oncology 2017).
`2013 - 2016 Pivotal Phase III Study to Evaluate Overall Survival Using MABp1 as a Monotherapy in Metastatic
`Colorectal Cancer Patients with Cachexia
`Sponsor: Xbiotech (NCT01767857)
`Site PI (Start-up $18,820; per patient $11,825)
`Interleukin-1 is a central mediator in cancer cachexia. A phase I study of MABp1, a fully humanized
`monoclonal antibody to interleukin -1 alpha, showed a promising signal in metastatic colorectal
`cancer. Yet, accrual to this study was limited by the requirement of >5% weight loss in the
`preceding 6 months (Lancet Oncology 2017). Again, this study fueled my desire to refine
`prospective methodology in evaluating novel compounds to treat cancer cachexia.
`2013 - 2016 A Double- Blind Randomized Three -Armed Phase II Trial of Pledox in Two Different Doses in
`Combination with FOLFOX6 Compared to Placebo + FOLFOX6 in Patients with Advanced
`Metastatic Colorectal (Stage IV) Cancer (PLIANT Study)
`Sponsor: Pled Pharma (NCT01619423)
`Site PI (Start-up $18,670; per patient $20,905)
`This international phase II study evaluated calmangafodipir (a superoxide dismutase mimetic and
`iron chelator) to prevent chemotherapy-related neutropenia and oxaliplatin -induced peripheral
`neuropathy. The phase II results were promising but lacked phase III data (Acta Oncology 2018).
`2015 - 2017 Observational Study of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients Receiving
`Multiday Highly Emetogenic Chemotherapy (HEC) Regimens for Hematological Malignancies
`Sponsor: Vector Oncology
`Site PI (Start-up $7,000; per patient $1,500)
`Evidence-based prophylaxis to prevent CINV in hematologic malignancy patients who receiv e
`multiday chemotherapy is lacking. This observational study aimed to collect information regarding
`clinician antiemetic prescribing patterns and patients' daily CINV experience.
`2016 - 2017 Phase II, Randomized, Single -Center, Pilot Feasibility Study to Evaluate Naloxegol for Opioid -
`Induced Constipation in Cancer Patients
`Sponsor: AstraZeneca (IND 160121, NCT02745353)
`Principal Investigator (Start-up $27,106; per patient $3,320)
`Opioid-induced constipation (OIC) is a common and distressing symptom for patients with cancer
`requiring burdensome self-titration of laxatives for prophylaxis and treatment. This proposed trial
`assessed the use of naloxegol in cancer -related OIC, utilizing an open- label cross over study
`compared to stimulant laxatives. Naloxegol, a peripherally selective opioid antagonist (PAMORA),
`was evaluated and approved in the non-cancer setting, but a randomized controlled trial in cancer
`failed to accrue. The primary aim of feasibility was not achieved.
`2017 - 2018 Fixed-Dose Combination of Netupitant and Palonosetron (Akynzeo) in the Treatment of Refractory
`Chemotherapy-Induced Nausea and Vomiting
`Sponsor: Helsinn Healthcare SA (IND 161691, NCT03008213)
`PI (Start-up $27,404; per patient $3,575)
`The primary aim of this phase II, open-label study was to determine the feasibility of using a fixed-
`dose combination of netupitant and palonosetron (Akynzeo) for the treatment of refractory CINV
`that occurs during subsequent chemotherapy cycles when prophylactic and rescue antiemetics
`are ineffective. The trial was closed early due to my departure from UC San Diego.
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`OHSU CV [Eric Roeland, MD]
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`2017 - 2018 Phase II, Open-Label Study to Evaluate Lazanda in Cancer Patients Receiving Palliative Radiation
`Vomiting
`Sponsor: Depomed (IND 161263, NCT03071744)
`PI (Start-up $11,574; per patient $3,467)
`In this phase II open-label study, we evaluated intranasal fentanyl as a premedication for patients
`receiving hypofractionated radiation for painful bony metastases. We enrolled 6 patients with
`improved tolerance to radiation treatments and decreased pain. The trial was terminated early
`due to my departure from UC San Diego.
`2021 - 2022 A 6-Week, Randomized, Double-Blind, Sponsor-Open Study to Assess the Effect of Repeated
`Subcutaneous Administration of PF-06946860 on Appetite in Participants with Advanced Cancer
`and Anorexia, Followed by an 18-week Open-Label Treatment Period (C3651010).
`Sponsor: Pfizer (NCT04803305)
`Site PI (Start-up $28,834, per patient $32,008)
`In this phase Ib study, the effects of PF-06946860 versus placebo were evaluated on cancer-
`associated anorexia and weight loss across various solid tumor cancers. This study’s primary aim
`was to assess the effects of repeated subcutaneous administration of PF-06946860—a
`recombinant humanized monoclonal antibody directed against the cytokine growth
`differentiation factor 15 (GDF-15)—on appetite in people with advanced cancer, anorexia, and
`elevated circulating GDF-15 levels (Clinical Cancer Research 2024). I presented this study at the
`European Society of Medical Oncology 2021; later, we participated in the phase II RCT.
`2022 - 2024 ONTARGET: A Phase 3 multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
`Evaluating Crofelemer for the Prophylaxis of Diarrhea in Adult Patients with Solid Tumors
`Receiving Targeted Cancer Therapies with or without Standard Chemotherapy (NP303-102).
`Sponsor: Napo Pharmaceuticals (NCT04538625)
`Executive Steer Committee, Co-I, Site PI (PI: Okhuysen; Start-up $32,316, per patient $16,713)
`This phase III study compared crofelemer with placebo to prevent diarrhea caused by tyrosine
`kinase inhibitors (TKIs) across various cancers, focusing on over 20 FDA-approved TKIs that cause
`diarrhea in more than 50% of patients. Crofelemer is an FDA-approved antidiarrheal that
`modulates chloride-ion activity in the intestine and has established safety with no drug
`interactions. The study enrolled 15 participants from the OHSU Knight Cancer Institute i