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NCT01525589 · ClinicalTrials.gov registry record · Phase 2
A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer
A Phase 2 study, sponsored by PharmaMar.
- Completed
- Registry status
- Phase 2
- Development phase
- 111
- Enrollment target
NCT01525589: Completed Phase 2 study, sponsored by PharmaMar.
NCT01525589 is a Phase 2 study that has completed, run by PharmaMar. The registered enrollment target is 111 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01525589, a Phase 2 study, has completed, sponsored by PharmaMar.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 111 participants
- Enrollment target
Study Summary
A Clinical Trial of PM01183 in Metastatic Breast Cancer to assess the antitumor activity of PM01183 ,to evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts response to PM01183 in Metastatic Breast Cancer (MBC) patients, to evaluate the safety profile of this PM01183 to analyze the pharmacokinetics (PK) and PK/PD (pharmacokinetic/pharmacodynamic) correlations and to evaluate the pharmacogenomic (PGx) expression profile in tumor samples.
Primary Outcome
The overall response rate is defined as the percentage of patients with a confirmed response, either complete response (CR) or partial response (PR), according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR \>=30% decrease in the sum of the longest diameter of target lesions.
Interventions
- DRUG PM01183
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2012-06-13 |
| Est. Completion | 2018-10 |
| Phase | Phase 2 |
What the finished NCT01525589 record still lists
NCT01525589 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 1 intervention - of which PM01183 is the first listed.
NCT01525589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01525589 about?
NCT01525589 is a clinical study titled "A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer". A Clinical Trial of PM01183 in Metastatic Breast Cancer to assess the antitumor activity of PM01183 ,to evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts response to PM01183 in Metastatic Breast Cancer (MBC) patients, to evaluate the safety profile of this PM01183 to an...
What is the current status of trial NCT01525589?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2012-06-13. Estimated completion is 2018-10.
What interventions are being tested in trial NCT01525589?
The interventions under investigation include: PM01183 (DRUG).
Who is sponsoring clinical trial NCT01525589?
This trial is sponsored by PharmaMar, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01525589's enrollment target sits among peer trials
111 632nd of 2000 higher than 1,369 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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