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

Pharma Mar, S.A.0 个研究点目标入组 117 人开始时间: 2012年2月10日最近更新: 2018年11月19日

适应症

试验速览

暂无简介。

•Women>=18 and <=75 years of age/Voluntary signed informed consent form before any study procedure/Histologically proven diagnosis of metastatic breast carcinoma/ At least one, but no more than three, prior chemotherapy-containing regimens for MBC/Patients with known HER-2 overexpressing tumors must have failed at least one prior trastuzumab-containing regimen for metastatic disease/Measurable disease as defined by RECIST v1.1/ECOG performance status 0 or 1/Adequate major organ function/Wash out periods prior to Day 1 of Cycle 1/Grade <=1 toxicity due to any previous cancer therapy according to NCI-CTCAE/ Patients of child-bearing potental must agree to use a medically approved contraception method until at least six weeks after the last study drug administration.
•Patients in Cohort A: Known deleterius germline mutation of BRCA 1/2.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 42
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 18

•Prior treatment with PM01183 or trabectedine/Prior RT in more than 35% of the bone marrow/ Prior or concurrent malignant disease unless in complete remission for more than five years/Histology other than ductal or lobulillar carcinoma of the breast/Symptomatic , steroid requiring or progressive central nervous system (CNS) involvement/Exclusively bone-limited disease/Relevant diseases or clinical situations which may increase patient´s risk/ Pregnant or breastfeeding women/ Impending need for RT/Limitation of the patient´s ability to comply with the treatment or to follow-up the protocol.
•Patients in Cohort B: Known deleterius germline mutation of BRCA 1/2.

发起方

Pharma Mar, S.A.