Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-02

Study Completion Date

2017-04-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

There will be two phases to this study. The lead-in phase will evaluate the safety, pharmacokinetics, and define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with nab-paclitaxel and gemcitabine (nab-P + G) in adults with previously untreated metastatic pancreatic ductal adenocarcinoma. The randomized treatment phase will evaluate the efficacy, safety, and tolerability of nab-P + G with either MMB administered at the MTD or placebo in adults with previously untreated metastatic pancreatic ductal adenocarcinoma. Participants will continue study treatment until disease progression, unacceptable toxicity, consent withdrawal, or participant's refusal of treatment. Following treatment, participants will be followed for safety for 30 days and for survival approximately every 3 months for up to 3 years.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer

NCT02570711

Metastatic Pancreatic Cancer

TERMINATED PHASE2

A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer

NCT02399137

Pancreatic Cancer

COMPLETED PHASE2

Nab-paclitaxel Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection

NCT02023021

Stage IA Pancreatic Adenocarcinoma Stage IB Pancreatic Adenocarcinoma Stage IIA Pancreatic Adenocarcinoma +1 more

COMPLETED PHASE2

Study of Nab-Paclitaxel and Gemcitabine With or Without SBP-101 in Pancreatic Cancer

NCT05254171

Pancreatic Cancer Metastatic Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Stage IV

RECRUITING PHASE2/PHASE3

Study of IDO Inhibitor in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer

NCT02077881

Metastatic Pancreatic Adenocarcinoma Metastatic Pancreatic Cancer

COMPLETED PHASE1/PHASE2

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.

Metastatic Pancreatic Ductal Adenocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Momelotinib

Participants will receive momelotinib plus nab-paclitaxel and gemcitabine.

Group Type EXPERIMENTAL

Momelotinib

Intervention Type DRUG

Tablet (s) administered orally once or twice daily

Nab-paclitaxel

Intervention Type DRUG

Intravenously administered over approximately 30-40 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle

Gemcitabine

Intervention Type DRUG

Intravenously administered over approximately 30 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle

Placebo

Participants will receive placebo to match momelotinib plus nab-paclitaxel and gemcitabine.

Group Type PLACEBO_COMPARATOR

Placebo to match momelotinib

Intervention Type DRUG

Placebo to match momelotinib tablets administered orally once or twice daily

Nab-paclitaxel

Intervention Type DRUG

Intravenously administered over approximately 30-40 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle

Gemcitabine

Intervention Type DRUG

Intravenously administered over approximately 30 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Momelotinib

Tablet (s) administered orally once or twice daily

Intervention Type DRUG

Placebo to match momelotinib

Placebo to match momelotinib tablets administered orally once or twice daily

Intervention Type DRUG

Nab-paclitaxel

Intravenously administered over approximately 30-40 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle

Intervention Type DRUG

Gemcitabine

Intravenously administered over approximately 30 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GS-0387 CYT387

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Presence of metastatic pancreatic adenocarcinoma plus 1 of the following:

* Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR
* Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreas origin in conjunction with either:

* The presence of a mass in the pancreas, OR
* A history of resected pancreatic adenocarcinoma
* Measurable disease per RECIST v1.1
* Adequate organ function defined as follows:

* Total bilirubin ≤ 1.25 x upper limit of the normal range (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
* Absolute neutrophil count (ANC) \> 1500 cells/mm\^3, platelet \> 100,000 cells/mm\^3, hemoglobin \> 9 g/dL
* Serum creatinine \< ULN OR calculated creatinine clearance (CrCl) of ≥ 60 ml/min
* Eastern Cooperative Oncology Group (ECOG ) 0 or 1
* Modified Glasgow prognostic score (mGPS) of 1 or 2 at Screening (randomized phase only)

Exclusion Criteria

* Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy for pancreatic adenocarcinoma
* Currently or previously treated with biologic, small molecule, immunotherapy, chemotherapy, or other agents for metastatic pancreatic carcinoma
* Major surgery within 28 days of first dose of study drug
* Minor surgical procedure(s) within 7 days of enrollment or not yet recovered from prior minor surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ≥ 1 day before enrollment is acceptable)
* Known positive status for HIV
* Chronic active or acute viral hepatitis A, B, or C infection (testing required for hepatitis B and C), or hepatitis B or C carrier
* Peripheral neuropathy ≥ Grade 2
* Known or suspected brain or central nervous system metastases
* Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma, adenocarcinoma originating from the biliary tree or cystadenocarcinoma
* History of interstitial pneumonitis and/or require supplemental oxygen therapy
* External biliary drain
* Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of enrollment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No