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NCT02077881 · ClinicalTrials.gov registry record · Phase 1
Study of IDO Inhibitor in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer
A Phase 1 study, sponsored by NewLink Genetics Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 157
- Enrollment target
NCT02077881: Completed Phase 1 study, sponsored by NewLink Genetics Corporation.
NCT02077881 is a Phase 1 study that has completed, run by NewLink Genetics Corporation. The registered enrollment target is 157 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (162% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02077881, a Phase 1 study, has completed, sponsored by NewLink Genetics Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 157 participants
- Enrollment target
Study Summary
This phase I/II trial is designed to efficiently identify the regimen limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. All subjects will receive the same standard gemcitabine plus nab-paclitaxel regimen, plus indoximod in doses increasing from 600 mg twice daily to, potentially, 1200 mg twice daily.
Primary Outcome
Phase 1 component: To identify the regimen limiting toxicity (RLT) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjects with metastatic adenocarcinoma of the pancreas. RLT will be considered as only grade 3 and 4 toxicities that are attributable to the test agent and result in the delay of the administration of the backbone chemotherapy, gemcitabine plus nab-paclitaxel.
Interventions
- DRUG Nab-Paclitaxel
- DRUG Gemcitabine
- DRUG Indoximod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2014-08 |
| Est. Completion | 2018-10-17 |
| Phase | Phase 1 |
What the finished NCT02077881 record still lists
NCT02077881 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (162% higher).
The record links to 0 conditions, and to 3 interventions - of which Nab-Paclitaxel is the first listed.
NCT02077881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02077881 about?
NCT02077881 is a clinical study titled "Study of IDO Inhibitor in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer". This phase I/II trial is designed to efficiently identify the regimen limiting toxicity (RLT) and recommended phase 2 dose (RP2D) for the combination of the immunotherapeutic agent indoximod when administered in combination with standard of care chemotherapy gemcitabine plus nab-paclitaxel in subjec...
What is the current status of trial NCT02077881?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 157 participants. The study started on 2014-08. Estimated completion is 2018-10-17.
What interventions are being tested in trial NCT02077881?
The interventions under investigation include: Nab-Paclitaxel (DRUG), Gemcitabine (DRUG), Indoximod (DRUG).
Who is sponsoring clinical trial NCT02077881?
This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02077881's enrollment target sits among peer trials
157 351st of 2000 higher than 1,650 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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