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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by PharmaMar
Sponsor:
Information provided by (Responsible Party):
PharmaMar
ClinicalTrials.gov Identifier:
NCT01525589
First received: January 30, 2012
Last updated: May 9, 2014
Last verified: May 2014

January 30, 2012
May 9, 2014
June 2012
March 2015   (final data collection date for primary outcome measure)
Overall response rate (ORR) [ Time Frame: Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment ] [ Designated as safety issue: No ]
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.
Overall response rate (ORR) [ Time Frame: Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment ] [ Designated as safety issue: No ]
The overal 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.
Complete list of historical versions of study NCT01525589 on ClinicalTrials.gov Archive Site
  • Progression-free survival (PFS) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) is defined as the period of time from the date of first infusion to the date of progression disease, death (due to any cause), or last tumor evaluation.
  • Overall survival (OS) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Overall survival rate at one year is defined as the estimated probability of patients to remain alive at one year. Overall survival (OS) will be defined as time from the date of first infusion to the date of death or last contact
Same as current
Not Provided
Not Provided
 
A 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

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.

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
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: PM01183
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
Experimental: PM01183
Intervention: Drug: PM01183
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
117
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women ≥ 18 and ≤ 75 years of age.
  • Voluntary signed informed consent form (ICF).
  • Proven diagnosis of metastatic breast cancer (MBC).
  • At least one, but no more than three, prior chemotherapy regimens for MBC.
  • Patients with known HER-2 overexpressing MBC must have failed at least one prior trastuzumab-containing regimen for metastatic disease.
  • Disease evaluable for response by specific appropriate criteria.
  • No or minimal disease-related symptoms not affecting patient daily activities.
  • Adequate major organ function (normal or minimal alteration in liver, kidney, hematological, metabolic and cardiac function)
  • Wash out periods prior to Day 1 of Cycle 1:

At least three weeks since the last chemotherapy (six weeks in some particular cases) and At least four weeks since the last radiotherapy (RT) > 30 Gy) and At least one week since the last hormonal therapy and At least two weeks since the last biological/investigational therapy

  • Minimal or no ongoing toxicity from immediately prior therapy according to specific appropriate criteria. Mild ongoing toxicity is allowed in case of alopecia, skin toxicity, fatigue and/or finger numbness or tumbling.
  • Patients of child-bearing potential must agree to use a medically approved contraception method until at least six weeks after the last study drug administration.

Inclusion criteria - Specifically to be included in Cohort A (otherwise patients might be included in Cohort B):

Known deleterious germline mutation of BRCA1/2 (hereditary breast cancer).

Exclusion Criteria:

  • Prior treatment with PM01183 or trabectedin.
  • Extensive prior RT.
  • Prior or concurrent malignant disease unless cured for more than five years.
  • Exceptions are breast cancer in the other breast.
  • Uncommon or rare subtypes of breast cancer.
  • Symptomatic or progressive brain metastases.
  • Bone-limited and exclusively metastases.
  • Relevant diseases or clinical situations which may increase patient's risk:

History of cardiac disease. Moderate breathing difficulties or oxygen requirement Active uncontrolled infection. Unhealed wound or presence of any external drainage. Chronically active viral hepatitis. Immunocompromised patients, including those known to be infected by human immunodeficiency virus (HIV).

Known muscular disease or functional alteration

  • Pregnant or breastfeeding women.
  • Impending need for immediate RT for symptomatic relief.
  • Limitation of the patient's ability to comply with the treatment or to follow-up the protocol.
Female
18 Years to 75 Years
No
United States
 
NCT01525589
PM1183-B-003-11
No
PharmaMar
PharmaMar
Not Provided
Not Provided
PharmaMar
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP