A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer
A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected
Metastatic Breast Cancer to assess the antitumor activity of PM01183 in terms of overall
response rate (ORR), duration of response (DR),clinical benefit [ORR or stable disease
lasting over three months (SD > 3 months)], progression free survival (PFS), and one-year
overall survival (1y-OS) and to evaluate whether the presence of a known germline mutation
in BRCA 1/2 predicts response to PM01183 in MBC patients, to explore the activity of PM01183
in specific breast cancer subpopulations according to hormonal receptor status, HER-2
overexpression, number and/or type of prior therapies, or according to other available
histological/molecular classifications, to evaluate the safety profile of this PM01183
administration schedule [Day 1 every three weeks (q3wk)] in this patient population, to
analyze the pharmacokinetics (PK) of PM01183 in this patient population, to explore PK/PD
(pharmacokinetic/ pharmacodynamic) correlations, if applicable and to evaluate the
pharmacogenomic (PGx) expression profile of selected putative markers potentially predictive
of response to PM01183, in tissues from archived tumor samples.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (ORR)
The overall response rate is defined as the percentage of patients with a confirmed response, either complete response or partial response, according to RECIST(Response Evaluation Criteria In Solid Tumors)v1.1.
Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment
No
United States: Food and Drug Administration
PM1183-B-003-11
NCT01525589
June 2012
March 2015
Name | Location |
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Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |