Spots Global Cancer Trial Database for A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer
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Trial Identification
Brief Title: A Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer
Official Title: A Multicenter Phase II Clinical Trial of PM01183 in BRCA 1/2-Associated or Unselected Metastatic Breast Cancer
Study ID: NCT01525589
Conditions
Interventions
Study Description
Brief 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.
Detailed Description: 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 tumor samples.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Stanford Women's Cancer Center, Stanford, California, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Weill Cornell Medical College - New York Presbyterian Hospital, New York, New York, United States
Abramson Cancer Center - Hospital of the University of Pennsylvania at Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Complexo Hospitalario Universitario A Coruña, A Coruna, A Coruña, Spain
Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, A Coruña, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Contact Details
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