Trial Search Results

CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell Carcinoma

This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma with a clear cell component.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839
  • Drug: Cabozantinib
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. Documented histological or cytological diagnosis of renal cell carcinoma with a
   clear-cell component

   2. Adult patients

   3. Karnofsky Performance Score (KPS) ≥ 70%

   4. Measurable Disease per RECIST 1.1

   5. 1-2 lines of prior therapy for advanced or metastatic RCC including one
   anti-angiogenic therapy (any VEGF pathway-targeted agent used either as monotherapy or
   as a component of a combination regimen) OR the combination regimen of nivolumab +
   ipilimumab

   6. Adequate hepatic, renal, cardiac and hematologic function

Exclusion Criteria:

   1. Prior treatment with cabozantinib (or other MET inhibitor) or CB-839

   2. Receipt of other anticancer therapy within 2-6 weeks, depending on the treatment

   3. Untreated or active brain metastases or central nervous system cancer, as defined per
   protocol

   4. Prior gastric surgery, small bowel resection, or other conditions that may impede
   adequate absorption of oral study drug

   5. Known active infection with HIV, Hepatitis B or C virus

   6. Inability to discontinue proton-pump-inhibitor use before randomization

   7. Patients who are pregnant or lactating

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shemeen Poushnejad
650-724-7662
Not Recruiting