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

  • Interventional
  • Recruiting
  • NCT03428217
Eligibility Details Visit Clinicaltrials.gov

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial Comparing CB-839 in Combination With Cabozantinib (CB-Cabo) vs. Placebo With Cabozantinib (Pbo-Cabo) in Patients With Advanced or Metastatic Renal Cell Carcinoma (RCC)

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.

This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) in combination with cabozantinib versus placebo with cabozantinib in Renal Cell Carcinoma patients with at least one and not more than 2 prior therapies in the advanced or metastatic setting.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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
  • Renal Cancer

At a Glance

National Government IDNCT03428217

IRB#IRB18-0249

Lead SponsorCalithera Biosciences, Inc

Lead PhysicianWalter Stadler

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting