Trials / Terminated
TerminatedNCT03875313
Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors
A Phase 1b/2 Open Label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor CB-839 in Combination With the PARP Inhibitor Talazoparib in Patients With Advanced or Metastatic Solid Tumors
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Calithera Biosciences, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 adenosine diphosphate ribose polymerase (PARP) inhibitor talazoparib in participants with advanced/metastatic solid tumors.
Conditions
- Solid Tumor
- Clear Cell Renal Cell Carcinoma
- TNBC - Triple-Negative Breast Cancer
- Colorectal Cancer
- CRC
- RCC
- ccRCC
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CB-839 | CB-839 oral tablets administered twice daily with food at the assigned dose level on 28 day cycles with talazoparib. |
| DRUG | Talazoparib | Talazoparib oral tablets administered at the standard dose once daily with or without food on 28 day cycles with CB-839. |
Timeline
- Start date
- 2019-05-20
- Primary completion
- 2020-07-29
- Completion
- 2020-07-29
- First posted
- 2019-03-14
- Last updated
- 2022-02-17
- Results posted
- 2022-02-17
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03875313. Inclusion in this directory is not an endorsement.