Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients

• Status: Withdrawn
• Trial end date: 2020-04-30
• Target enrollment: 0
• Participant gender: Female

Summary

This is a phase II clinical trial of the combination of carboplatin, eribulin, and Veliparib.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Carboplatin; Veliparib

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