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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 is a Phase 1 study that has completed, run by NewLink Genetics Corporation. The registered enrollment target is 157 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02077881
The ClinicalTrials.gov registry entry for NCT02077881 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 157 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NewLink Genetics Corporation, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nab-Paclitaxel is the first listed.
NCT02077881 reports 0 study locations.
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.
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