NeoOPTIMIZE: Early Switching Of MFOLFIRINOX Or Gemcitabine/Nab-Paclitaxel Before Surgery For The Treatment Of Resectable, Borderline Resectable, Or Locally-Advanced Unresectable Pancreatic Cancer

Study Overview

NeoOPTIMIZE: Early Switching of mFOLFIRINOX or Gemcitabine/Nab-Paclitaxel Before Surgery for the Treatment of Resectable, Borderline Resectable, or Locally-Advanced Unresectable Pancreatic Cancer

This phase II trial evaluates whether early switching from modified fluorouracil/irinotecan/leucovorin/oxaliplatin (mFOLFIRINOX) chemotherapy regimen to a combination of gemcitabine and nab-paclitaxel (GA) before surgery is effective in treating patients with pancreatic cancer that can be surgically removed (resectable or borderline resectable), or that has spread to nearby tissue or lymph nodes and cannot be removed by surgery (locally-advanced unresectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, oxaliplatin, gemcitabine, and nab-paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The study will also evaluate the drug losartan in combination with mFOLFIRINOX or GA.

PRIMARY OBJECTIVE: I. To determine the rate of margin-negative (R0) resection in participants with resectable or borderline resectable pancreatic cancer (BRPC) following treatment using NeoOPTIMIZE adaptive therapy (i.e., FOLFIRINOX alone, or switch to GA). SECONDARY OBJECTIVES: I. To determine the progression-free survival (PFS) of resectable or BRPC participants that received NeoOPTIMIZE adaptive therapy (i.e., FOLFIRINOX, or switch to GA). II. To determine the PFS for the subset of resectable or BRPC participants that received NeoOPTIMIZE adaptive therapy, plus preoperative radiation therapy (RT). III. To determine the disease-free survival (DFS) of resectable or BRPC participants that received NeoOPTIMIZE adaptive therapy (i.e., FOLFIRINOX, or switch to GA). IV. To determine the DFS for the subset of resectable or BRPC participants that received NeoOPTIMIZE adaptive therapy plus preoperative RT. V. To determine the overall survival (OS) of resectable or BRPC participants that received NeoOPTIMIZE adaptive therapy. VI. To determine the OS for the subset of resectable or BRPC participants that received NeoOPTIMIZE adaptive therapy plus preoperative RT. VII. To assess the surgical complications of resectable or BRPC participants that undergo surgical resection. VIII. To assess 30-day post-operative mortality of participants with resectable or BRPC that undergo surgical resection. IX. To assess safety of NeoOPTIMIZE adaptive therapy (all participants). EXPLORATORY OBJECTIVES: I. To monitor changes in CA19-9 levels (all participants). II. To determine the rate of margin-negative (R0) resection in patients with locally advanced pancreatic cancer (LAPC), following treatment using NeoOPTIMIZE adaptive therapy (i.e., FOLFIRINOX alone, or switch to GA). III. To determine the PFS of LAPC participants that received NeoOPTIMIZE adaptive therapy (i.e., FOLFIRINOX, or switch to GA). IV. To determine the PFS for the subset of LAPC participants that received NeoOPTIMIZE adaptive therapy plus preoperative radiation therapy (RT). V. To determine the disease-free survival (DFS) of LAPC participants that received NeoOPTIMIZE adaptive therapy (i.e., FOLFIRINOX, or switch to GA). VI. To determine the DFS for the subset of LAPC participants that received NeoOPTIMIZE adaptive therapy plus preoperative RT. VII. To determine the OS of LAPC participants that received NeoOPTIMIZE adaptive therapy. VIII. To determine the OS for the subset of LAPC participants that received NeoOPTIMIZE adaptive therapy plus preoperative RT. IX. To assess the surgical complications of LAPC participants that undergo surgical resection. X. To assess 30-day post-operative mortality of LAPC participants who undergo surgical resection. OUTLINE: mFOLFIRINOX REGIMEN: Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on day 1. Patients also receive fluorouracil IV over 46 hours starting on day 1. Treatment with mFOLFIRINOX repeats every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo disease restaging (re-stage I). Patients with radiographic response and no disease progression receive mFOLFIRINOX for an additional 2 months (approximately 4 cycles). Patients then undergo second re-staging (re-stage II). GA REGIMEN: After re-stage I, patients with disease progression or toxicity to mFOLFIRINOX (per assessment of the treating physician) switch to receive the GA regimen comprising gemcitabine hydrochloride IV over 30-60 minutes and nab-paclitaxel IV over 30-40 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo second re-staging (re-stage II). Patients may be switched to GA regimen from FOLFIRINOX regimen prior to re-stage I (per assessment of the treating physician). LOSARTAN: Starting cycle 1 day 1, patients also receive losartan potassium orally (PO) once daily (QD) until completion of RT in the absence of disease progression or unacceptable toxicity. RT/SURGERY: Patients with no vascular tumor involvement at re-stage II, undergo surgery 1-4 after completion of chemotherapy. Patients with resolution of tumor contact with pancreatic vasculature at re-stage II, undergo short-course RT to receive a total of 10 fractions over 5 days weekly (Monday-Friday). Patients with tumor vessel involvement that is persistent at re-stage II, undergo long-course RT to receive a total of 15-25 fractions over 5 days weekly (Monday-Friday), and receive capecitabine PO twice daily (BID) on Monday-Friday or fluorouracil IV over 5-7 days weekly until completion of RT. Patients then undergo surgery 1-4 weeks after completion RT. Patients undergo diagnostic imaging as clinically indicated throughout the trial. Patients also undergo blood sample collection throughout the trial. After completion of study treatment, patients are followed up as clinically indicated and following institutional standards, and then every 3 months for 6 months, and then every 6 months for up to 2 years.

Pancreatic Adenocarcinoma
Stage 0 Pancreatic Cancer AJCC v8
Stage I Pancreatic Cancer AJCC v8
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8

DRUG: Capecitabine
DRUG: Fluorouracil
DRUG: Irinotecan Hydrochloride
DRUG: Leucovorin Calcium
DRUG: Losartan Potassium
DRUG: Oxaliplatin
RADIATION: Radiation Therapy
PROCEDURE: Resection
PROCEDURE: Diagnostic Imaging
PROCEDURE: Biospecimen Collection

STUDY00021614
NCI-2020-06277 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
STUDY00021614 (OTHER Identifier) (OTHER: OHSU Knight Cancer Institute)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-08-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-01-02
First Submitted that Met QC Criteria 2020-08-31	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-01-03
First Posted (ACTUAL) 2020-09-07	Results First Posted N/A	Last Verified 2025-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment (mFOLFIRINOX, chemotherapy) mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycle	DRUG: Capecitabine Given PO DRUG: Fluorouracil Given IV DRUG: Irinotecan Hydrochloride Given IV DRUG: Leucovorin Calcium Given IV DRUG: Losartan Potassium Given PO DRUG: Oxaliplatin Given IV RADIATION: Radiation Therapy Undergo short-course or long-course RT PROCEDURE: Resection Undergo surgical resection PROCEDURE: Diagnostic Imaging Undergo diagnostic imaging PROCEDURE: Biospecimen Collection Undergo blood sample collection

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment (mFOLFIRINOX, chemotherapy)

mFOLFIRINOX REGIMEN: Oxaliplatin intravenously (IV) over 2 hrs, leucovorin calcium IV over 2 hrs, and irinotecan hydrochloride IV over 90 minutes on day 1. Also receive fluorouracil IV over 46 hrs starting on day 1. Repeats every 14 days for up to 4 cycle

DRUG: Capecitabine

Given PO

DRUG: Fluorouracil

Given IV

DRUG: Irinotecan Hydrochloride

Given IV

DRUG: Leucovorin Calcium

Given IV

DRUG: Losartan Potassium

Given PO

DRUG: Oxaliplatin

Given IV

RADIATION: Radiation Therapy

Undergo short-course or long-course RT

PROCEDURE: Resection

Undergo surgical resection

PROCEDURE: Diagnostic Imaging

Undergo diagnostic imaging

PROCEDURE: Biospecimen Collection

Undergo blood sample collection

Primary Outcome Measures	Measure Description	Time Frame
Proportion of participants with R0 resection	Using the surgery analysis set, the proportion of participants with R0 resection will be estimated with exact 95% confidence interval.	Up to time of surgery

Secondary Outcome Measures	Measure Description	Time Frame
Progression-free survival (PFS) NeoOPTIMIZE	Using the efficacy analysis set, the estimated distribution of the PFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., gemcitabine/nab-paclitaxel [GA] or modified fluorouracil/irinotecan/leucovorin/oxaliplatin [mFOLFIRINOX] +/- radiation therapy [RT] [i.e., short- or long-course, or both RT modalities combined]) will be performed for PFS.	From the start of neoadjuvant therapy (day 1) to the time of tumor progression, or death due to any cause, assessed up to 24 months
PFSNeoOPTIMIZE + pre-operative (preop)-RT	Using the efficacy analysis set, the estimated distribution of the PFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX +/- RT [i.e., short- or long-course, or both RT modalities combined]) will be performed for PFS.	From the start of neoadjuvant therapy (day 1) to the time of tumor progression, or death due to any cause, assessed up to 24 months
Disease-free survival (DFS) NeoOPTIMIZE	Using the surgery analysis set, the estimated distribution of the DFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. Using the efficacy analysis set, the estimated distribution of the DFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX +/- RT [i.e., short- or long-course, or both RT modalities combined]) will be performed for DFS.	From the date of surgery to the time of tumor progression, or death due to any cause, assessed up to 24 months
DFSNeoOPTIMIZE + preop-RT	Using the efficacy analysis set, the estimated distribution of the DFS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX +/- RT [i.e., short- or long-course, or both RT modalities combined]) will be performed for DFS.	From the date of surgery to the time of tumor progression, or death due to any cause, assessed up to 24 months
Overall survival (OS) NeoOPTIMIZE	Using the efficacy analysis set, the estimated distribution of the OS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. Using the efficacy analysis set, the estimated distribution of the OS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX +/- RT [i.e., short- or long-course, or both RT modalities combined]) will be performed for OS.	From the start of neoadjuvant therapy (day 1) to death due to disease, assessed up to 24 months
OSNeoOPTIMIZE + preop-RT	Using the efficacy analysis set, the estimated distribution of the OS will be plotted using Kaplan Meier curves and reported with median survival and 95% confidence intervals if available. When feasible, sub-group analyses for the different treatment regimens (i.e., GA or mFOLFIRINOX] +/- RT [i.e., short- or long-course, or both RT modalities combined]) will be performed for OS.	From the start of neoadjuvant therapy (day 1) to death due to disease, assessed up to 24 months
Proportion of participants with peri- and post-operative complications	Peri- and post-operative complications occurring within 30 days following surgery will be categorized per the Clavien-Dindo classification system. Using the surgery analysis set, the proportion of participants with peri- and post-operative complications occurring within 30 days following surgery.	Up to 30 days after surgery
Proportion of participants that die within 30 days of surgery	The proportion of 30-day post-operative mortality will be estimated and reported with two-sided exact 95% confidence intervals. If necessary, the proportion of 30-day post-operative mortality may be estimated from the Kaplan Meier product limit method.	At 30 days post-surgery
Incidence of grade >= 3 toxicities	The incidence of grade >= 3 toxicities per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 will be determined using the safety analysis set. The exact 95% confidence interval will be reported with the point estimate of toxicity rate. Adverse events will be tabulated by the Medical Dictionary for Regulatory Activities (MedDRA version 21.1) preferred term and system organ class and a preferred term. The severity of the adverse events (AE) will be assessed by National Cancer Institute (NCI) CTCAE v 5.0 criteria. Descriptive statistics using the safety analysis set will be used to report on all on-study AEs, grade 3-4 AEs, treatment-related AEs, grade 3-4 treatment-related AEs, serious adverse events (SAEs), treatment-related SAEs, and AEs leading to discontinuation per CTCAE v 5.0. Grade 3-4 laboratory abnormalities will be summarized using worst grade NCI CTCAE v 5.0 criteria.	Up to 90 days after last dose of protocol-directed therapy

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Ability to understand and the willingness to sign a written informed consent document
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Cytologic or histologic proof pancreatic ductal carcinoma is required prior to study entry

If a biopsy (e.g., endoscopic ultrasound [EUS]-guided fine needle aspiration [FNA]) is planned per standard of care, the participant may be asked to consent to the additional collection of tumor tissue for research
No evidence of metastatic disease as determined by chest computed tomography (CT) scan, abdomen/pelvis computed tomography (CT) scan (or magnetic resonance imaging [MRI] with gadolinium and/or manganese) within the 45-day window of study entry or prior to the one cycle of standard of care (SOC) administered before study entry, which is consistent with the standard of care

Note: On a case by case basis, for participants who enroll on trial after having received up to 1 month of standard of care chemotherapy per Investigator discretion, baseline radiographic imaging performed per institutional guidelines prior to SOC chemotherapy treatment may be used per investigator discretion to fulfill baseline radiographic imaging criteria even if performed > 45 days prior to official study entry.
Diagnostic staging laparoscopy is not required for study eligibility

If staging laparoscopy is planned per standard of care, the participant may be asked to consent to the collection of tumor tissue for research
At time of screening, per National Comprehensive Cancer Network (NCCN) criteria, must have either:

Resectable pancreatic ductal adenocarcinoma (PDAC), defined as no arterial tumor contact (celiac axis [CA], superior mesenteric artery [SMA], or common hepatic artery [CHA]), or
Node positive disease as defined by CT, MRI, or EUS imaging, or
Borderline resectable PDAC, defined as:

For tumors of the head or uncinate process:

Solid tumor contact with the superior mesenteric vein (SMV) or portal vein of > 180 degrees with contour irregularity of the vein or thrombosis of the vein, but with suitable vessel proximal and distal to the site of involvement, allowing for safe and complete resection and vein reconstruction
Solid tumor contact with the inferior vena cava
Solid tumor contact with the common hepatic artery without extension to the celiac axis or hepatic artery bifurcation, allowing for safe and complete resection and reconstruction
Solid tumor contact with the SMA =< 180 degrees
Solid tumor contact with variable anatomy (e.g., accessory right hepatic artery, replaced right hepatic artery, replaced common hepatic artery, and the origin of replaced or accessory artery), and the presence and degree of tumor contact should be noted if present, as it may affect surgical planning
For tumors of the body/tail:

Solid tumor contact with the celiac axis of =< 180 degrees
Solid tumor contact with the celiac axis >180 degrees without involvement of the aorta and with an intact and uninvolved gastroduodenal artery, thereby permitting a modified Appleby procedure (although some members of the consensus committee preferred this criterion to be in the unresectable category)
Locally-advanced, unresectable disease as defined by NCCN guidelines as follows:

Tumors of the head with SMA >= 180 degrees, or any celiac abutment, unreconstractable SMV or portal occlusion, or aortic invasion or encasement
Tumors of the body with SMA or celiac encasement 180 degrees, unreconstractable SMV or portal occlusion, or aortic invasion
Tumors of the tail with SMA or celiac encasement >= 180 degrees
Irrespective of location, all tumors with evidence of nodal metastasis outside of the resection field that are considered unresectable
Must be deemed fit to undergo planned curative resection as determined by institutional standards
No history of previous chemotherapy for pancreatic cancer. At the discretion of the principal investigator (PI), patient that have received no more than 1 month of systemic chemotherapy (e.g., mFOLFIRINOX), per standard of care, for the treatment of their PDAC may be eligible to participate
For participants who will get INV losartan, baseline systolic blood pressure (BP) > 100 mm Hg taken as the average of 3 blood pressure readings
Hemoglobin > 9 g/dL with no blood transfusion within 28 days of starting treatment (prior to the one month of standard of care chemotherapy allowed by the protocol or within 4 weeks of screening)

Note: On a case by case basis, for participants who enroll on trial after having received up to 1 month of standard of care chemotherapy per Investigator discretion, labs prior to initiation of SOC chemotherapy treatment may be used per Investigator discretion to fulfill screening lab requirements even if performed > 4 weeks prior to official study entry and/or there are more recent labs available from during chemotherapy treatment
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L (> 1000 cells/mm^3) (prior to the one month of standard of care chemotherapy allowed by the protocol or within 4 weeks of screening)

Note: On a case by case basis, for participants who enroll on trial after having received up to 1 month of standard of care chemotherapy per Investigator discretion, labs prior to initiation of SOC chemotherapy treatment may be used per Investigator discretion to fulfill screening lab requirements even if performed > 4 weeks prior to official study entry and/or there are more recent labs available from during chemotherapy treatment
May be waived on a case-by-case basis for patient populations recognized to have normal baseline values below this level
Platelet count >= 100 x 10^9/L (> 100,000 per mm^3) (at time of registration and within 4 weeks prior to initiating study therapy)
Creatinine =< 1.5 mg/dL OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 30 mL/min/1.73 m^2 for participants with creatinine levels > 1.5 x institutional upper limit of normal (ULN) prior to the one month of standard of care chemotherapy allowed by the protocol or within 4 weeks of screening)

Note: On a case by case basis, for participants who enroll on trial after having received up to 1 month of standard of care chemotherapy per Investigator discretion, labs prior to initiation of SOC chemotherapy treatment may be used per Investigator discretion to fulfill screening lab requirements even if performed > 4 weeks prior to official study entry and/or there are more recent labs available from during chemotherapy treatment
Creatinine clearance should be calculated per institutional standard. For participants with a baseline calculated creatinine clearance below normal institutional laboratory values, a measured baseline creatinine clearance should be determined. Individuals with higher values felt to be consistent with inborn errors of metabolism will be considered on a case-by-case basis
Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN); or =< 2 x ULN or 2 down-trending values for individuals who have undergone biliary stenting prior to the one month of standard of care chemotherapy allowed by the protocol or within 4 weeks of screening)

Note: On a case by case basis, for participants who enroll on trial after having received up to 1 month of standard of care chemotherapy per Investigator discretion, labs prior to initiation of SOC chemotherapy treatment may be used per Investigator discretion to fulfill screening lab requirements even if performed > 4 weeks prior to official study entry and/or there are more recent labs available from during chemotherapy treatment
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN, OR two consecutive down-trending values for individuals who have undergone biliary stenting prior to the one month of standard of care chemotherapy allowed by the protocol or within 4 weeks of screening)

Note: On a case by case basis, for participants who enroll on trial after having received up to 1 month of standard of care chemotherapy per Investigator discretion, labs prior to initiation of SOC chemotherapy treatment may be used per Investigator discretion to fulfill screening lab requirements even if performed > 4 weeks prior to official study entry and/or there are more recent labs available from during chemotherapy treatment
Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to initiating study therapy. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Female participants of childbearing potential agree to use adequate methods of contraception starting with the first dose of study therapy through 30 days after the last dose of study therapy

Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year without an alternative medical cause
Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 30 days after the last dose of study therapy
Male patients must use a condom during treatment when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male participant should also use a highly effective form of contraception if they are of childbearing potential
Participants currently receiving an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) will remain eligible for study participation. In such cases, losartan will not be assigned as part of the study intervention. These participants will continue to receive their ACE inhibitor or ARB per standard-of-care. The ACE inhibitor or ARB type should be recorded as a concomitant medication (including dose and frequency)

History of previous chemotherapy (other than no more than one cycle of standard systemic chemotherapy), targeted/biologic therapy, or radiation therapy for the treatment of their PDAC
Evidence of metastasis to distant organs (liver, peritoneum, lung, others)
Any other active malignancy or prior history of malignancy with less than a 90% cure rate in the judgement of the investigators
Medical co-morbidities that are deemed to make risk of surgery unacceptably high as determined by institutional standards
Personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Patients with cardiovascular conditions that are well-controlled in the clinical judgement of the treating oncologist are eligible to participate
Recent major surgery (excluding laparoscopy) within 4 weeks prior to starting study treatment. Minor surgery within 2 weeks of starting study treatment. Patients must be recovered from effects of surgery
Concomitant use of other anti-cancer therapy (chemotherapy, immunotherapy, hormonal therapy [hormone replacement therapy is acceptable]), not otherwise allowed in this study. Note: participation in other trials for supportive cancer care (e.g., cancer-related cachexia) interventions is permitted per PI discretion.
Participants with a history of hypersensitivity reactions to study agents or their excipients. In cases of losartan hypersensitivity, losartan will be omitted and patient may still be eligible to participate
Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 30 days after the last dose of trial therapy
Psychiatric illness/social situations, or any condition that, in the opinion of the investigator, would: interfere with evaluation of study treatment or interpretation of participant safety or study results, or substantially increase risk of incurring adverse events (AEs), or compromise the ability of the patient to give written informed consent
Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Oregon Health and Science University

Investigators

PRINCIPAL_INVESTIGATOR: Charles D Lopez, OHSU Knight Cancer Institute

Publications

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