Trial Search Results

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

The main aim of this clinical trial is to test the effects (good or bad) of a new investigational anticancer drug, PM01183, has on breast cancer. The knowledge obtained from this trial might allow fighting against this type of cancer in a more specific way in the future.

PM01183 is a novel anticancer compound that has been selected for further clinical development because of the anti-cancer activity shown in the laboratory and of its adequate toxicity profile in animals.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

PharmaMar

Intervention(s):

  • Drug: PM01183

Phase:

Phase 2

Eligibility


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.

   - Known deleterious germline mutation of BRCA1/2 (Patients in Cohorts A and A1)

   - Prior treatment with PARP inhibitors (Patients in Cohort A1)

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.

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting