Status:
TERMINATED
Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors
Lead Sponsor:
Calithera Biosciences, Inc
Conditions:
Solid Tumor
Clear Cell Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor CB-839 with the poly aden...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- (Part 1)
- Documented incurable/locally advanced or metastatic solid tumors that have either relapsed or are refractory or intolerant to standard therapies of proven clinical benefit.
- (Part 2) Meets 1 of the 3 defined cohorts:
- Cohort 1: Documented incurable/locally advanced or metastatic ccRCC
- Cohort 2: Documented incurable/locally advanced or metastatic defined as ER, PR negative (\<1%) and HER2 negative (immunohistochemistry 0 to 1+ or fluorescence in situ hybridization \[FISH\] negative)
- Cohort 3: incurable/locally advanced or metastatic CRC
- For both Parts 1 \& 2:
- Recovery to baseline or ≤ Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 from toxicities related to the prior therapy
- Adequate renal, hepatic, and hematological function
- Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 evaluable disease (Part 1) or measurable disease (Part 2)
- Ability to provide written consent in accordance with federal, local and institutional guidelines
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Exclusion Criteria for both Parts 1 \& 2:
- Prior treatment with CB-839 or a PARP inhibitor
- Unable to received oral medications
- Active and/or untreated central nervous system metastasis. Patients with treated brain metastases must have (1) documented radiographic stability of at least 4 weeks duration demonstrated on baseline central nervous system (CNS) imaging prior to study treatment and (2) be symptomatically stable and off steroids for at least 2 weeks before administration of any study treatment.
- Major surgery within 28 days prior to first dose of study drug
- Receipt of any anticancer therapy within the following windows: small molecule tyrosine kinase inhibitor therapy (including investigational) within the prior 2 weeks or 5 half-lives prior to C1D1, whichever is longer; any type of anti-cancer antibody or cytotoxic chemotherapy within 4 weeks prior to C1D1; radiation therapy for bone metastasis within 2 weeks prior or any other external radiation therapy within 4 weeks prior to C1D1; patients with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Exclusion
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2020
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03875313
Start Date
May 20 2019
End Date
July 29 2020
Last Update
February 17 2022
Active Locations (9)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114