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

NCT01525589

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

A Phase II Clinical Trial of <span class="go-doc-concept go-doc-intervention">PM01183</span> in BRCA 1/2-Associated or Unselected Metastatic <span class="go-doc-concept go-doc-disease">Breast Cancer</span>

Title

  • 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
  • Clinical Trial IDs

    NCT ID: NCT01525589

    ORG ID: PM1183-B-003-11

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    PM01183 PM01183

    Trial Purpose

    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 archived tumor samples.

    Trial Arms

    Name Type Description Interventions
    PM01183 Experimental PM01183

    Eligibility Criteria

    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.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: 75 Years

    Eligible Gender: Female

    Primary Outcome Measures

    Overall response rate (ORR)

    Secondary Outcome Measures

    Progression-free survival (PFS)

    Overall survival (OS)

    Trial Keywords

    Breast cancer

    PM01183

    lurbinectedin

    Pharma Mar