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Completed Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT02077881

Public ClinicalTrials.gov record NCT02077881. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 11:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I/II Study of Indoximod in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Adenocarcinoma of the Pancreas

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02077881
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
NewLink Genetics Corporation
Industry
Enrollment
157 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2014
Primary completion
Jan 16, 2018
Completion
Oct 16, 2018
Last update posted
Apr 2, 2026

2014 – 2018

United States locations

U.S. sites
11
U.S. states
10
U.S. cities
11
Facility City State ZIP Site status
Stanford University Palo Alto California 94304
Augusta University Augusta Georgia 30912
University of Kentucy Lexington Kentucky 40536
Washington University in St. Louis St Louis Missouri 63110
The Vally Hospital Paramus New Jersey 07652
University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15232
Greenville Health Systems Greenville South Carolina 29605
Gibbs Cancer Center and Research Institute Spartanburg South Carolina 29303
The West Clinic Memphis Tennessee 38120
Huntsman Cancer Center Salt Lake City Utah 84112
University of Vermont Medical Center Burlington Vermont 05401

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02077881, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 2, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02077881 live on ClinicalTrials.gov.

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