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Closed (no longer recruiting)Last updated: 31 January 2024

CANTATA: This phase II trial is evaluating a new oral drug (CB-839) in combination with cabozantinib (a different oral drug), compared to cabozantinib alone in patients with advanced or metastatic renal cell carcinomaA Randomized, Double-Blind, Placebo-Controlled Phase 2 Study 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)

Clinical summary

Summary

Participants enrolled in this trial will be randomised into one of two arms. In the experimental arm, CB-839 will be given orally twice daily and cabozantinib once daily. In the comparator arm a placebo will be given orally twice daily and cabozantinib once daily.

Conditions

This trial is treating patients with renal cell carcinoma.

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

II

Trial Acronym

CANTATA

More information

Trial Identifiers

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Trial sponsor

Calithera Biosciences, Inc

Scientific Title

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study 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)

Eligibility

Inclusion

  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 Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
  5. 1-2 lines of prior therapy for advanced or metastatic renal cell carcinoma (RCC) including one anti-angiogenic therapy (any vascular endothelial growth factor [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

  1. Prior treatment with cabozantinib (or other mesenchymal-epithelial transition [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 human immunodeficiency virus (HIV), Hepatitis B or C virus
  6. Inability to discontinue proton-pump-inhibitor use before randomization
  7. Patients who are pregnant or lactating

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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