combination of carboplatin, eribulin and veliparib in stage iv cancer patients

Conditions: Breast Cancer Stage IV; Ovarian Cancer; BRCA1 Mutation; BRCA2 Mutation

Summary: this is a phase ii clinical trial of the combination of carboplatin, eribulin, and veliparib.

this is a phase ii, non-randomized, open-label, clinical trial on the combination of carboplatin, eribulin, and veliparib in patients with brca-related cancers.

Eligibility criteria:
inclusion criteria: * patients must have archival biopsy specimens (preferably from metastatic disease) available for research tests. if a suitable biopsy specimen is not available, patients will be asked to undergo a research biopsy to procure tissue * patients must be \>/= 18 years * females of childbearing potential must not have had unprotected sexual intercourse within 30 days prior to study entry and must agree to use a highly effective method of contraception. females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation * patients must have an ecog performance status 0-1 * patients may have had a prior diagnosis of cancer if it has been \> 5 years since their last treatment for that cancer * patients must have normal organ and marrow function as defined below: * leukocytes ≥ 3,000/ul * absolute neutrophil count ≥ 1,500/ul * platelets ≥ 100,000/ul * creatinine within normal limits or creatinine clearance ≥30 * patients must be able to swallow and retain oral medication * patients who were receiving prior systemic therapy: prior treatment related side effects must have resolved to \< grade 2 severity (except alopecia and infertility) * all patients must have given signed, informed consent prior to registration on study * patients must have stage iv breast or stage iii and iv ovarian cancer (including platinum sensitive disease) * patients must have brca1/2 deleterious mutations, pten deficiency, or cancer with a high hrd score as assessed by myriad's assay * patients must have measurable disease per recist 1.1 criteria (see above for definition) * patients may not have received more than 3 chemotherapeutic regimens for metastatic disease * patients may not have received treatment with prior carboplatin, eribulin or a parp inhibitor exclusion criteria: * women who are pregnant or lactating are not eligible * patients who are undergoing concomitant radiotherapy are not eligible * patients who are receiving any other investigational agents or concurrent anticancer therapy are not eligible * previous systemic treatment is allowed with a 21 day washout period prior to registration * patients who are taking any herbal (alternative) medicines are not eligible. patients must be off any such medications by the time of registration * patients with known brain metastases are not eligible for participation unless the following are met: * brain metastases are treated (either with surgical excision, stereotactic radiosurgery or radiotherapy and have been stable for at least 4 weeks (mri documented) * patient is asymptomatic and has discontinued corticosteroids if taken for that purpose * patients with any of the following conditions or complications are not eligible for participation: * gi tract disease resulting in an inability to take oral medication * malabsorption syndrome * require iv alimentation * history of prior surgical procedures affecting absorption * uncontrolled inflammatory gi disease (e.g., crohn's, ulcerative colitis). * hypersensitivity of any of the components of veliparib, carboplatin, eribulin * history of significant neurological (no neuropathy \> grade 2) or psychiatric disorders. * significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis). * significant non-neoplastic renal disease. * immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (hiv). * uncontrolled endocrine diseases (e.g., diabetes mellitus, hypothyroidism or hyperthyroidism, adrenal disorder) i.e., requiring relevant changes in medication within the last month or hospital admission within the last three months * active infection requiring systemic therapy. * significant cardiovascular impairment: history of congestive heart failure greater than new york heart association (nyha) class ii, uncontrolled arterial hypertension, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia requiring medical treatment. * prolongation of qtc interval to \> 480 msec when electrolytes balance is normal. * major surgery within 4 weeks prior to the first dose of study drug