Trial · NCT01792050
Study of Chemotherapy in Combination With IDO Inhibitor in Metastatic Breast Cancer
NCT01792050, Phase 2, Completed, NewLink Genetics Corporation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Chemotherapy in Combination With IDO Inhibitor in Metastatic Breast Cancer. Trials, record NCT01792050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01792050
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Chemotherapy in Combination With IDO Inhibitor in Metastatic Breast Cancer
- NCT number
- NCT01792050
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 169 participants, actual
- Lead sponsor
- NewLink Genetics Corporation
- Conditions
- Metastatic Breast Cancer
- Interventions
- Docetaxel, Placebo, Indoximod, Paclitaxel
- First posted
- 2013-02-15
- Last updated
- 2020-05-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | 12 months | 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. |
| Secondary | Frequency and grade of adverse events of docetaxel and paclitaxel in combination with indoximod versus docetaxel alone | 12 months | A secondary objective of this phase 2 study is to determine the safety/toxicity (frequency and grade of adverse events) of docetaxel or paclitaxel in combination with indoximod versus docetaxel or paclitaxel plus placebo. |
| Secondary | Correlation of clinical and pathologic variables and clinical benefit (progression free survival rate) from treatment | 12 months | A secondary objective of this phase 2 study is determining the correlation between clinical and pathologic variables and clinical benefit from docetaxel or paclitaxel and indoximod. |
| Secondary | Median Overall Survival | 12 months | A secondary objective of this phase 2 study is to observe median overall survival of all patients. |
| Secondary | Objective Response Rate (Complete Response + Partial Response) | 12 Months | A secondary objective is to determine the objective response rate (CR+PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) of docetaxel or paclitaxel + indoximod compared to docetaxel or paclitaxel plus placebo. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33151286 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01792050
GET https://conductscience.org/api/trials/v1/NCT01792050/registered