Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a double blinded placebo-controlled study where patients will be randomized 2:1 to either CB-839 plus everolimus (CBE) or placebo plus everolimus (PboE)
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double blinded, placebo-controlled

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
CB-839 plus everolimus
CBE: CB-839 is administered twice daily in combination with standard doses of everolimus
  • Drug: CB-839 plus everolimus
    CB-839 is administered as oral tablets twice daily (BID) in combination with standard daily (QD) everolimus in 28 day cycles.
    Other names:
    • Affinitor
Placebo Comparator
Placebo plus everolimus
PboE: Placebo is administered twice daily in combination with standard doses of everolimus
  • Drug: Placebo plus everolimus
    Placebo is administered as oral tablets twice daily (BID) in combination with standard daily (QD) everolimus in 28 day cycles.
    Other names:
    • Affinitor

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10461
Contact:
Benjamin Gartrell, MD
718-405-8404
bgartrel@montefiore.org

More Details

NCT ID
NCT03163667
Status
Recruiting
Sponsor
Calithera Biosciences, Inc

Study Contact

Clinical Administrator
650-870-1000
clinicaltrials@calithera.com

Detailed Description

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing CB-839 in Combination with Everolimus (CBE) vs. Placebo with Everolimus (PboE) in Patients with Advanced or Metastatic Renal Cell Carcinoma (RCC)

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.