Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Calithera Biosciences, Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Karnofsky Performance Score (KPS) ≥ 70%
Estimated Life Expectancy of at least 3 months
Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component.
Measurable Disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the Investigator
Must have received at least two prior lines of systemic therapy, including at least one VEGF 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 months prior to Cycle 1 Day 1 (C1D1).
Prior treatment with other anti-cancer therapies including cytokines, monoclonal antibodies, immunotherapies, and cytotoxic chemotherapy is allowed
You may not be if
Prior treatment with mammalian target of rapamycin (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
Unable to receive medications orally (PO) or any condition that may prevent adequate absorption of oral study medication
Major surgery within 28 days prior to 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
Clareo Health | CB-839 With Everolimus vs. Placebo With Everolimus in Participants With Renal Cell Carcinoma (RCC)
