Trial Search Results

ENTRATA: CB-839 With Everolimus vs. Placebo With Everolimus in Patients With RCC

Phase 2 Study Comparing CB-839 in Combination with Everolimus (CBE) vs. Placebo with Everolimus (PboE) in Patients with Advanced or Metastatic RCC

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839 plus everolimus
  • Drug: Placebo plus everolimus

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Karnofsky Performance Score (KPS) ≥ 70%

   - Estimated Life Expectancy of at least 3 mo

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

   - Measurable Disease per RECIST 1.1 as determined by the Investigator

   - Must have received at least two prior lines of systemic therapy, including at least
   one VEGFR-targeting TKI (e.g., sunitinib, sorafenib, pazopanib, cabozantinib)

   a) Radiographic progression of mRCC must have occurred (per investigator assessment)
   on or after the most recent systemic therapy and within 6 mo prior to C1D1.

   - Prior treatment with other anti-cancer therapies including cytokines, monoclonal
   antibodies, immunotherapies, and cytotoxic chemotherapy is allowed

Exclusion Criteria:

   - Prior treatment with mTOR inhibitors (everolimus or temsirolimus) or CB-839

   - Receipt of any anticancer therapy within the following windows before randomization:

      - TKI therapy within 2 weeks or 5 half-lives, whichever is longer

      - Any type of anti-cancer antibody within 4 weeks

      - Cytotoxic chemotherapy within 4 weeks

      - Investigational therapy within 4 weeks or 5 half-lives, whichever is longer

      - Radiation therapy for bone metastasis within 2 weeks, any other external
      radiation therapy within 4 weeks before randomization. Patients with clinically
      relevant ongoing complications from prior radiation therapy are not eligible.

   - Unable to receive medications PO or any condition that may prevent adequate absorption
   of oral study medication

   - Major surgery within 28 days prior to randomization

   - Patients with active and/or untreated central nervous system (CNS) cancer are not
   eligible. Patients with treated brain metastasis must have 1) documented radiographic
   stability of at least 4 weeks duration demonstrated on baseline contrast-enhanced CNS
   imaging (eg contrast-enhanced MRI of the brain) prior to randomization and 2) must be
   symptomatically stable and off steroids for at least 2 weeks before randomization.

   - Requirement for continued proton pump inhibitor after randomization

   - Chronic treatment with corticosteroids or other immunosuppressive agents except (i)
   inhaled or topical steroids or replacement dose corticosteroids equivalent to ≤ 10 mg
   prednisone and (ii) patients receiving physiological doses of hydrocortisone for
   adrenal insufficiency

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
CCTO
650-498-7061
Not Recruiting