CB-839 in Combination With Niraparib in Platinum Resistant BRCA -Wild-type Ovarian Cancer Patients

Stopped early · Phase 1

Conditions studied: Ovarian Cancer, Resistant BRCA Wild-Type Ovarian Cancer

In brief

The purpose of this protocol is to investigate the efficacy of the combination of CB-839 with Niraparib in platinum resistant BRCA wild-type ovarian cancer patients. The primary and secondary objectives are to determine the maximum tolerated dose of CB-839 in combination with Niraparib and to determine the response rate and percentage of participants who remain progression free at 6 months.

Key facts

Study ID

NCT03944902

Run by

University of Alabama at Birmingham

People needed

1

Starts

2021-09-01

Expected to finish

2022-01-05

Last updated by the study team

2023-11-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Estimated life expectancy of at least 3 months
• Measurable disease; at least one tumor lesion/lymph node that meets the RECIST 1.1 criteria for measurability
• Negative serum or urine pregnancy test within 3 days prior to the first dose
• Serum creatinine <= 2.0 x upper limit of normal (ULN)
• Adequate hematological function
• Alanine aminotransferase (ALT) \& aspartate aminotransferase (AST) <3.0 x ULN
• Total bilirubin <=1.5 x ULN

You may not qualify if…

• Prior treatment with CB-839 or a PARP inhibitor
• Receipt of any anticancer therapy within the following windows:
• Small molecule tyrosine kinase inhibitor therapy (including investigational) within 2 weeks or 5 half-lives, whichever is longer
• Any type of anti-cancer antibody within 4 weeks
• Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization
• Subjects with clinically relevant ongoing complications from prior radiation therapy
• Other investigational therapy within 2 weeks or 5 half-lives, whichever is longer
• Any other current or previous malignancy within he past three years except:
• Adequately treated basal cell or squamous cell skin cancer
• Carcinoma in situ of the cervix
• Prostate cancer with stable prostate specific antigen (PSA) levels for >3 years
• Other neoplasm that, in the opinion of the Principal Investigator, will not interfere with the study-specific endpoints

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• UCSF — San Francisco, California, United States
• MAYO Clinic — Rochester, Minnesota, United States
• Allegheny Health Network Research Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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