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NCT02101021 · ClinicalTrials.gov registry record · Phase 3
Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 3 study, sponsored by Sierra Oncology LLC - a GSK company.
- Terminated
- Registry status
- Phase 3
- Development phase
- 25
- Enrollment target
NCT02101021: Clinical Trial Phase 3 study, sponsored by Sierra Oncology LLC - a GSK company.
NCT02101021 is a Phase 3 study that was terminated before completion, run by Sierra Oncology LLC - a GSK company. The registered enrollment target is 25 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02101021, a Phase 3 study, was terminated before completion, sponsored by Sierra Oncology LLC - a GSK company.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 25 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Dose limiting toxicities were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Dose limiting toxicities referred to toxicities experienced during the first 28 days (Cycle 1) of treatment that were judged to be clinically significant and related to study treatment. No statistical analysis was planned or performed for this endpoint.
Interventions
- DRUG Gemcitabine
- DRUG Momelotinib
- DRUG Nab-paclitaxel
- DRUG Placebo to match momelotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2014-06-02 |
| Est. Completion | 2017-04-10 |
| Phase | Phase 3 |
Why NCT02101021 stopped before completion
NCT02101021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 4 interventions - of which Gemcitabine is the first listed.
NCT02101021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02101021 about?
NCT02101021 is a clinical study titled "Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma". 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 adenocarcin...
What is the current status of trial NCT02101021?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2014-06-02. Estimated completion is 2017-04-10.
What interventions are being tested in trial NCT02101021?
The interventions under investigation include: Gemcitabine (DRUG), Momelotinib (DRUG), Nab-paclitaxel (DRUG), Placebo to match momelotinib (DRUG).
Who is sponsoring clinical trial NCT02101021?
This trial is sponsored by Sierra Oncology LLC - a GSK company, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02101021's enrollment target sits among peer trials
25 1941st of 2000 higher than 58 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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