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Trial #NCT01525589

Breast Cancer Clinical Trials

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
Study ID: PM1183-B-003-11; Source: PharmaMar
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Recruiting
Country United States
Study type Interventional
Enrollment 117
Start date June 2012
Completion date March 2015
Phase Phase 2
Sponsor PharmaMar
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.
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.
Eligibility:
Gender: Both
Age: 18 Years - 75 Years
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.
Outcome:
Primary outcome
  • Overall response rate (ORR)
    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.
    Time frame: Minimum 10-12 months if negative results and up to 26-28 months if study is to be complete the targeted enrollment
Secondary outcome
  • Overall survival (OS)
    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
    Time frame: 36 months
  • Progression-free survival (PFS)
    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.
    Time frame: 36 months
Location Country Status
Massachusetts General Hospital Boston, Massachusetts United States Recruiting
Sponsors:
  • PharmaMar - (Lead Sponsor)
Related trials: Terms
  • Breast cancer
  • PM01183
  • lurbinectedin
  • Pharma Mar
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