BRCA1 / BRCA2 associated or unselected Metastatic Breast Cancer. MedDRA version: 14.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: PM01183
Product Code: PM01183
Pharmaceutical Form: Powder for concentrate for solution for infusion
CAS Number: 497871-47-3
Current Sponsor code: PM01183
Other descriptive name: PM01183
Sponsors
Pharma Mar, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women>=18 and =65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antitumor activity of PM01183 in terms of overall response rate (ORR) according to RECIST vs 1.1 in each cohort of metastatic breast cancer (MBC) patients.;Secondary Objective: Characterize the antitumor activity of PM01183 in terms of duration of response (DR) clinical benefit, progression free survival (PFS) and one-year overall survival (ly-OS) /Evaluate whether the presence of a known germline mutation in BRCA 1/2 predicts response of PM01183 in MBC patients/Explore activity of PM01183 in specific breast cancer subpopulations/ Evaluate safety profile of PM01183/Explore PK/PD correlations if applicable/Evaluate PGx expression.;Primary end point(s): Overall response rate (ORR), according to RECIST v.1.1, in each cohort of metastatic breast cancer (MBC) patients.;Timepoint(s) of evaluation of this end point: Timepoint (TP): Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of response (DR)/ Clinical benefit, defined as the percentage of patients with ORR or SD> 3 months, according to RECIST v1.1/Progression-free survival (PFS)/ Overall survival rate at one year (1y-OS)/ Treatment safety/PK analysis and PK/PD correlation, if applicable/ PGx expression profile.;Timepoint(s) of evaluation of this end point: Duration of response (DR). TP: 36 months Clinical benefit, defined as the percentage of patients with ORR or SD > 3 months, according to RECIST v1.1. (TP:29-32 months) Progression-free survival (PFS). TP: 36 months Overall survival rate at one year (1y-OS). 36 months Treatment safety: AEs, serious AEs (SAEs) and laboratory abnormalities will be graded according to the NCI-CTCAE (v4). (25-26 months) PK analysis and PK/PD correlation, if applicable. 36 months approximately PGx expression profile, in tissues from archived tumor samples: 36 months | — |
Countries
Spain, United States
Contacts
Public ContactClinical Trials
Pharma Mar, S.A.
Outcome results
None listed