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NCT03057600 · ClinicalTrials.gov registry record · Phase 2
Study of CB-839 in Combination w/ Paclitaxel in Participants of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC)
A Phase 2 study, sponsored by Calithera Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT03057600: Completed Phase 2 study, sponsored by Calithera Biosciences.
NCT03057600 is a Phase 2 study that has completed, run by Calithera Biosciences. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03057600, a Phase 2 study, has completed, sponsored by Calithera Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with paclitaxel in participants of African ancestry and non-African ancestry with advanced triple negative breast cancer. Multiple single-arm cohorts will be enrolled in which 800 mg twice daily (BID) CB-839 will be administered in combination with the full approved dose of paclitaxel.
Primary Outcome
ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1criteria: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessment performed no less than 4
Interventions
- DRUG Paclitaxel
- DRUG CB-839
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2019-11-25 |
| Phase | Phase 2 |
What the finished NCT03057600 record still lists
NCT03057600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT03057600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03057600 about?
NCT03057600 is a clinical study titled "Study of CB-839 in Combination w/ Paclitaxel in Participants of African Ancestry and Non-African Ancestry With Advanced Triple Negative Breast Cancer (TNBC)". CX-839-007 is an open-label Phase 2 study of the combination of CB-839 with paclitaxel in participants of African ancestry and non-African ancestry with advanced triple negative breast cancer. Multiple single-arm cohorts will be enrolled in which 800 mg twice daily (BID) CB-839 will be administered ...
What is the current status of trial NCT03057600?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2017-05-01. Estimated completion is 2019-11-25.
What interventions are being tested in trial NCT03057600?
The interventions under investigation include: Paclitaxel (DRUG), CB-839 (DRUG).
Who is sponsoring clinical trial NCT03057600?
This trial is sponsored by Calithera Biosciences, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03057600's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 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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