CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 111 enrolled
Drug / intervention
PM01183drug
Likely dose
PM01183 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01525589
NCT01525589Phase 2Completed
CompareCT.gov

A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer

PharmaMar·interventional·Posted Feb 3, 2012·Updated Sep 25, 2020

In Brief

A Phase 2 clinical trial evaluating PM01183 for Breast Cancer. Completed, enrolled 111 participants across 9 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesSpain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2012
Enrollment StartJun 13, 2012
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 14.4 years ago

Interventions

PM01183drug

PM01183 drug product (DP) is presented as a lyophilized powder for concentrate for solution for infusion with two strengths: 1 mg/vial and 4 mg/vial