Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02101021
The ClinicalTrials.gov registry entry for NCT02101021 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sierra Oncology LLC - a GSK company, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Gemcitabine is the first listed.
NCT02101021 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.