A Multi-center Trial to Evaluate Multiple Regimens in Metastatic Pancreatic Cancer
NCT ID: NCT04229004
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
502 participants
INTERVENTIONAL
2020-01-31
2025-02-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Primary Objectives
* To compare each investigational arm versus standard of care (SOC) for superiority in overall survival in first and/or second line metastatic ductal adenocarcinoma (metastatic pancreatic cancer) participants and determine which, if any, participants benefit from each investigational arm.
Secondary Objectives
* To determine short and long-term safety signals of each investigational arm in metastatic pancreatic cancer participants vs. SOC.
* To determine progression-free survival (PFS) for each investigational arm vs. SOC.
* To determine rates of overall response, CR, and PR; duration of overall response, CR or PR (whichever occurs first).
* To determine rates of clinical benefit; duration of clinical benefit.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread
NCT04233866
Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer
NCT02570711
A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer
NCT03512756
A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer
NCT07283705
Precision-Panc Master Protocol: Personalising Treatment for Pancreatic Cancer
NCT04161417
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Gemcitabine combined with nab-paclitaxel
Arm is closed to recruitment.
The following are recommended parameters for infusion timing and sequence, although institutional variation in the administration of the regimen are permitted as long as drug dosing and modification guidelines are followed.
Gemcitabine combined with nab-paclitaxel
Arm is closed to recruitment.
Nab-paclitaxel is infused over 30-40 min on days 1, 8, 15 of each 28-day cycle. Gemcitabine is infused over 30 min, immediately after completion of nab-paclitaxel infusion, on days 1, 8, 15 of each 28-day cycle.
If one of the chemotherapy medications is held, the other study medications may be given.
Doses should be re-adjusted if the participant's weight changes by +/- \>10%. If the participant's weight changes by \<10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current weight according to institutional guidelines.
mFOLFIRINOX
Arm is closed to recruitment.
Oxaliplatin 85 mg/m2, Leucovorin 400 mg/m2, Irinotecan 150 mg/m2, 5-Fluorouracil 2400 mg/m2 46-48 hour infusion
Dose -mFOLFIRINOX
Arm is closed to recruitment.
The following are recommended parameters for infusion timing and sequence, although institutional variation in the administration of the regimen are permitted, as long as drug dosing and modification guidelines are followed. Oxaliplatin and leucovorin are administered concurrently over 30-120 minutes, followed by irinotecan over 30-90 minutes, followed by the infusion of 5-flurouracil. If one of the chemotherapy medications is held, the other study medications may be given. Doses should be re-adjusted if the participant's weight changes by +/- \>10%. If the participant's weight changes by \<10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current weight according to institutional guidelines.
pamrevlumab (FibroGen)
Arm is closed to recruitment.
Experimental: Pamrevlumab in combination with gemcitabine/nab-paclitaxel.
Participants enrolled to this treatment arm will receive treatment with pamrevlumab in combination with gemcitabine and nab-paclitaxel.
Gemcitabine and nab-paclitaxel are FDA approved therapies for metastatic pancreatic cancer and will be supplied or obtained according to local clinical study agreements and in accordance with local guidelines.
Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel
Arm is closed to recruitment.
Pamrevlumab 35mg/kg IV - Cycle 1 (Day 1, 8, 15 of the 28 day cycle) and Cycle 2 and Onward (Day 1 and 15)
Nab-paclitaxel 125mg/m2 IV - Day 1, 8, 15 for every 28 day cycle
Gemcitabine 1000mg/m2 IV - Day 1, 8, 15 for every 28 day cycle
Canakinumab and Spartalizumab
Arm is closed to recruitment.
Canakinumab and Spartalizumab in Combination with Nab-Paclitaxel and Gemcitabine.
Participants enrolled to this treatment arm will receive treatment with Canakinumab and Spartalizumab in combination with nab-paclitaxel and gemcitabine.
Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabine
Arm is closed to recruitment.
Canakinumab 250mg SC- Day 1 of every 28 day cycle
Spartalizumab 400 mg IV - Day 1 of every 28 day cycle
Nab-paclitaxel 125mg/m2 IV - Day 1, 8, 15 of every 28 day cycle
Gemcitabine 1000mg/m2 IV - Day 1, 8, 15 of every 28 day cycle
Experimental: SM-88
Arm is closed to recruitment.
460 mg (2 capsules) twice daily of a 28-day cycle along with the administration of methoxsalen, phenytoin and sirolimus.
All four agents (SM-88, methoxsalen, phenytoin, and sirolimus) should be dosed with approximately 240 mL (8 fl. oz.) of water in the morning. All four agents should be taken together consistently. SM-88 used with MPS should ideally be taken approximately 1 hour before or 2 hours after a meal.
Drug: Dose -SM-88
Arm is closed to recruitment.
460 mg (2 capsules) twice daily of a 28-day cycle along with the administration of methoxsalen, phenytoin and sirolimus.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gemcitabine combined with nab-paclitaxel
Arm is closed to recruitment.
Nab-paclitaxel is infused over 30-40 min on days 1, 8, 15 of each 28-day cycle. Gemcitabine is infused over 30 min, immediately after completion of nab-paclitaxel infusion, on days 1, 8, 15 of each 28-day cycle.
If one of the chemotherapy medications is held, the other study medications may be given.
Doses should be re-adjusted if the participant's weight changes by +/- \>10%. If the participant's weight changes by \<10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current weight according to institutional guidelines.
Dose -mFOLFIRINOX
Arm is closed to recruitment.
The following are recommended parameters for infusion timing and sequence, although institutional variation in the administration of the regimen are permitted, as long as drug dosing and modification guidelines are followed. Oxaliplatin and leucovorin are administered concurrently over 30-120 minutes, followed by irinotecan over 30-90 minutes, followed by the infusion of 5-flurouracil. If one of the chemotherapy medications is held, the other study medications may be given. Doses should be re-adjusted if the participant's weight changes by +/- \>10%. If the participant's weight changes by \<10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current weight according to institutional guidelines.
Dose - Pamrevlumab combined with gemcitabine and nab-paclitaxel
Arm is closed to recruitment.
Pamrevlumab 35mg/kg IV - Cycle 1 (Day 1, 8, 15 of the 28 day cycle) and Cycle 2 and Onward (Day 1 and 15)
Nab-paclitaxel 125mg/m2 IV - Day 1, 8, 15 for every 28 day cycle
Gemcitabine 1000mg/m2 IV - Day 1, 8, 15 for every 28 day cycle
Dose- Canakinumab and Spartalizumab combined with nab-paclitaxel and gemcitabine
Arm is closed to recruitment.
Canakinumab 250mg SC- Day 1 of every 28 day cycle
Spartalizumab 400 mg IV - Day 1 of every 28 day cycle
Nab-paclitaxel 125mg/m2 IV - Day 1, 8, 15 of every 28 day cycle
Gemcitabine 1000mg/m2 IV - Day 1, 8, 15 of every 28 day cycle
Drug: Dose -SM-88
Arm is closed to recruitment.
460 mg (2 capsules) twice daily of a 28-day cycle along with the administration of methoxsalen, phenytoin and sirolimus.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) and eligible for treatment in the first line or second line settings.
* Acceptable histologies include adenosquamous carcinoma, mucinous adenocarcinoma, hepatoid carcinoma, medullary carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, and undifferentiated carcinoma with osteoclast-like-cells, and adenocarcinoma. Pancreatic neuroendocrine tumors (PNET) are excluded.
* Radiographically measurable disease by computed tomography (CT) scan or magnetic resonance imaging (MRI) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Imaging results must be obtained within the 28-day window, prior to randomization.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Adequate organ function (lab results must be obtained within the 28-day window prior to randomization)
* Absolute neutrophil count ≥ 1500/mm3
* Hemoglobin ≥ the lower limit of normal (LLN) or 9g/dL
* Platelets ≥ 100,000/mm3
* Serum creatinine ≤ 1.0 x upper limit normal (ULN), or calculated creatinine clearance ≥ 50 mL/min (Cockcroft Gault)
* Albumin ≥ 3.0 g/dL
* Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x ULN (up to ≤ 5 x ULN in presence of liver metastasis).
* Total bilirubin ≤ 1.5 x ULN
* INR ≤ 1.5 x ULN (up to ≤ 2 x ULN for participants on anticoagulation therapy).
* Participants must be willing to provide protocol-mandated tissue and blood samples for diagnostic and research purposes as a condition of enrollment into the trial.
* Able to swallow pills, capsules or tablets.
* Able to adhere to study visit schedule and other protocol requirements.
* Participants of childbearing potential \[defined as a person assigned as female at birth who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)\] must:
* Have a negative serum or urine pregnancy test (β-human chorionic gonadotropin \[β-hCG\]) as verified by the study doctor within 14 days prior to randomization.
* Commit to complete abstinence from sexual contact with persons assigned as male at birth or agree to use medical doctor-approved contraception without interruption while participating in the study, during dose interruptions and for at least 6 months following last dose of study treatment.
* Participants assigned as males at birth must practice complete abstinence or agree to use a condom (even if he has undergone a successful vasectomy) during sexual contact with persons of childbearing potential while participating in the study, during dose interruptions and for at least 6 months following last dose of study treatment.
* known HIV-infected participants on effective anti-retroviral therapy are eligible if the most recent viral load test performed within six months of screening (based on medical chart review) is negative. If this is not the case, an HIV viral load test should be performed at screening and be negative (i.e., undetectable).
* Known HBV-infected participants are eligible if the most recent viral load test performed within six months of screening (based on medical chart review) is negative. If this is not the case, an HBV viral load test should be performed at screening and be negative (i.e., undetectable).
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with known HCV infection who are currently on treatment are eligible if the most recent viral load test performed within six months of screening (based on medical chart review) is negative. If this is not the case, an HCV viral load test should be performed at screening and be negative (i.e., undetectable).
* Participants with a history of brain metastases are eligible provided they show evidence of stable lesions (and no new lesions) with no evidence of tumor progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. In addition, any neurological symptoms that developed either as a result of the brain metastases or their treatment, must have returned to baseline or resolved. Any steroids administered as part of this therapy must be completed \> 7 days prior to the first dose of trial therapy.
* No known leptomeningeal disease.
* Participants with a prior or concurrent malignancy whose natural history does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible. Participants receiving any active therapy for a concurrent secondary malignancy are excluded.
* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using New York Heart Association Functional Classification. To be eligible for this trial, participants should be Class 2 or better. Class 2 is defined as slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest.
* Understands the nature of the study and has agreed to participate by voluntarily signing the IRB approved informed consent.
Exclusion Criteria
* Received any anti-cancer systemic therapy within 21 days (or 5 half-lives, whichever is shorter,) prior to randomization.
* Has had major surgery within 14 days prior to enrollment.
* History of known allergy or hypersensitivity to any of the study treatments or any of their excipients or contraindication to any of the study treatments as outlined in the local prescribing information (e.g., United States Prescribing Information \[USPI\]).
* Pre-existing peripheral neuropathy \> Grade 1, as defined by CTCAE V 4.03.
* Known active tuberculosis infection.
* Serious, non-healing wound, ulcer, or bone fracture.
* The inability to swallow pills, capsules or tablets.
* Receiving any active therapy for concurrent secondary malignancy. Participants with a prior or concurrent malignancy whose natural history and/or management does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible.
* History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, and pulmonary hypersensitivity pneumonitis.
* QTc \> 450 msec if male and QTc \> 470 msec if female.
* Uncontrolled or severe cardiac disease (history of unstable angina, myocardial infarction, coronary stenting, or bypass surgery within the prior 6 months), symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia \[including atrial flutter/fibrillation\].
* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using New York Heart Association Functional Classification. Participants worse than Class 2 are excluded. Class 2 is defined as slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest.
* Active, uncontrolled infections (bacterial, viral, or fungal infection(s)) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment (i.e., Participants must be afebrile for \> 48 hours off antibiotics).
* Active, known or suspected autoimmune disease, including systemic lupus erythematosus, Hashimotos thyroiditis, scleroderma, polyarteritis nodosa or autoimmune hepatitis.
o Participants with type I diabetes mellitus, hypothyroidism requiring only hormone replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are eligible to participate.
* Receiving immunosuppressive or myelosuppressive medications that would, in the opinion of the Investigator, increase the risk of serious neutropenic complications. Participants receiving replacement therapy of 10 mg of prednisone (or the equivalent hydrocortisone dose) per day are eligible.
* Receipt of live vaccines within 30 days prior to the first dose of study treatment or while on active treatment within the trial. (examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are permitted. However, intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines and are not permitted).COVID-19 vaccines are permitted.
* Any significant medical condition, laboratory abnormality or psychiatric illness that would limit the participant's ability to comply with study requirements.
* Participants that discontinued previous treatment for pancreatic adenocarcinoma due to a treatment-related ≥ Grade 3 toxicity.
o For toxicity ≤ Grade 3, AE(s) must resolve to Grade 1 or baseline in order to be considered eligible for this trial.
* Participants that have received allogenic bone marrow or solid organ transplants are excluded.
* Participants that are pregnant, planning on becoming pregnant, or are breast feeding.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pancreatic Cancer Action Network
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Florida College of Medicine
Gainesville, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan - Rogel Cancer Center
Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center (MCCC)
Rochester, Minnesota, United States
Siteman Cancer Center - Washington University Medical Campus
St Louis, Missouri, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
New York University Langone Medical Center - Perlmutter Cancer Center
New York, New York, United States
Evelyn H. Lauder Breast Center - Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Physicians - Solid Tumor/Gastrointestinal Oncology
New York, New York, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States
Virginia Mason Hospital & Seattle Medical Center
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rayego-Mateos S, Morgado-Pascual JL, Lavoz C, Rodrigues-Diez RR, Marquez-Exposito L, Tejera-Munoz A, Tejedor-Santamaria L, Rubio-Soto I, Marchant V, Ruiz-Ortega M. CCN2 Binds to Tubular Epithelial Cells in the Kidney. Biomolecules. 2022 Feb 3;12(2):252. doi: 10.3390/biom12020252.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PanCAN_Precision Promise
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.