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Study of BMN-673 With Carboplatin and Paclitaxel in Patients With Advanced BRCA-mutated Solid Tumor or Triple Negative Metastatic Breast Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Study of BMN-673 With Carboplatin and Paclitaxel in Patients With Advanced BRCA-mutated Solid Tumor or Triple Negative Metastatic Breast Cancer

Phase I Study to Evaluate the Tolerability, Safety and Efficacy of BMN-673 in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumor Malignancies That Have BRCA Mutations or Triple Negative Metastatic Breast Cancer

NCT02358200•Pamela Munster

View on ClinicalTrials.gov

Summary

Open label, non-randomized, dose escalation and expansion Phase Ia/b trial to evaluate the safety of the combination of BMN 673 and carboplatin, and subsequently BMN 673 in combination with paclitaxel and carboplatin to determine the recommended Phase II dose of the combination.

Detailed Description

Poly adenosine diphosphate-ribose polymerase (PARP) 1/2 inhibitors are a novel class of anticancer agents that have shown activity in tumors with defects in DNA repair and may induce synthetic lethality in combination with agents that induce DNA damage by preventing DNA repair. The rationale of this study is to determine whether a DNA damaging agent can potentiate the cell death induced by PARP inhibitors in individuals with tumor that are more susceptible to chemotherapy. The study will evaluate the potential benefits of BMN 673 in combination with weekly carboplatin in patients with metastatic tumors associated with BRCA germ line mutations or patients with triple negative breast cancer with no known BRCA mutation, subsequently if tolerated, an additional cohort will examine the feasibility of adding paclitaxel to this combination for any solid tumor malignancies with potential benefit to this combination. This is the first study to evaluate the safety and efficacy of BMN 673 in combination with carboplatin in patients with either BRCA mutations or TNBC. If tolerable paclitaxel will be added to the combination in any solid tumor malignancies with potential benefit to this combination.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men and women, 18 years or older with advanced malignancies for which no standard therapy is available.
•Dose Escalation: Patients with any solid tumor malignancies
•Does Expansion:
•Patients with advanced malignancies that have germline and/or somatic BRCA mutations (cohort gBRCA) Or
•Triple negative (TN) metastatic breast cancer without known BRCA mutation (cohort TNBC). Tumors will be considered TN when:
•Estrogen receptor (ER) expression \<1%
•Progesterone receptor (PR) expression \<1%
•Her2 negative as per the American Society of Clinical Oncology (ASCO) guidelines
•Paclitaxel expansion: any solid tumor malignancy with potential benefit from this combination and paclitaxel (ASP).
•Consent to screening tumor biopsy (for accessible tumors when appropriate) \[optional in dose escalation, mandatory in dose expansion\]
+16 more criteria

Exclusion Criteria

•Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks, whichever is shorter, prior to starting study treatment
•Patients must have recovered from side effects from prior cancer-directed therapy to grade 1 or less (unless deemed not clinically significant by study investigator).
•Major surgery ≤ 4 weeks prior to starting study regimen or who have not recovered from surgery.
•Any known unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA) class 3 or 4 congestive heart failure.
•History of myocardial infraction (MI) within 6 month prior to starting study treatment.
•Any significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
•Any condition that confounds the ability to interpret data from the study.
•Symptomatic central nervous system metastases. Subjects with brain metastases that have been previously treated and are stable for 4 weeks are allowed.
•Malabsorption or uncontrolled peptic ulcer disease
•Grade 2 or higher peripheral neuropathy (paclitaxel arm only)
+3 more criteria

Locations (1)

University of California San Francisco

San Francisco, California, United States

Key Dates

Start Date

February 23, 2015

Primary Completion Date

January 8, 2019

Completion Date

January 8, 2019

Last Updated

January 10, 2020

Enrollment

ACTUAL participants

Conditions

Triple Negative Metastatic Breast CancerBRCA-mutated Solid Tumor

Interventions

BMN-673

DRUG

Carboplatin

DRUG

Paclitaxel

DRUG

Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer

NCT01069796

Triple Negative Metastatic Breast Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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