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NCT01792050 · ClinicalTrials.gov registry record · Phase 2

Study of Chemotherapy in Combination With IDO Inhibitor in Metastatic Breast Cancer

A Phase 2 study, sponsored by NewLink Genetics Corporation.

Completed
Registry status
Phase 2
Development phase
169
Enrollment target

NCT01792050: Completed Phase 2 study, sponsored by NewLink Genetics Corporation.

NCT01792050 is a Phase 2 study that has completed, run by NewLink Genetics Corporation. The registered enrollment target is 169 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01792050, a Phase 2 study, has completed, sponsored by NewLink Genetics Corporation.

COMPLETED
Registry status
Phase 2
Development phase
169 participants
Enrollment target

Study Summary

The purpose of this study is to compare the effects, good and/or bad, of standard of care therapy (docetaxel or paclitaxel) with or without the addition of 1-Methyl-D-tryptophan (referred to as indoximod) an experimental drug to find out which treatment is better.

Primary Outcome

The primary objective of this phase 2 study is the progression free survival of docetaxel or paclitaxel in combination with indoximod compared to docetaxel or paclitaxel plus placebo in metastatic breast cancer.

Interventions

  • DRUG Docetaxel
  • OTHER Placebo
  • DRUG Paclitaxel
  • DRUG Indoximod

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2013-02
Est. Completion 2017-07-07
Phase Phase 2
NewLink Genetics Corporation

31 total trials

What the finished NCT01792050 record still lists

NCT01792050 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher).

The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.

NCT01792050 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01792050 about?

NCT01792050 is a clinical study titled "Study of Chemotherapy in Combination With IDO Inhibitor in Metastatic Breast Cancer". The purpose of this study is to compare the effects, good and/or bad, of standard of care therapy (docetaxel or paclitaxel) with or without the addition of 1-Methyl-D-tryptophan (referred to as indoximod) an experimental drug to find out which treatment is better.

What is the current status of trial NCT01792050?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2013-02. Estimated completion is 2017-07-07.

What interventions are being tested in trial NCT01792050?

The interventions under investigation include: Docetaxel (DRUG), Placebo (OTHER), Paclitaxel (DRUG), Indoximod (DRUG).

Who is sponsoring clinical trial NCT01792050?

This trial is sponsored by NewLink Genetics Corporation, which has 31 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01792050's enrollment target sits among peer trials

169 403rd of 2000 higher than 1,598 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01792050, the US trial registry maintained by the National Library of Medicine. NCT01792050 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.