ENTRATA: CB-839 With Everolimus vs. Placebo With Everolimus in Patients With RCC (ENTRATA)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03163667 |
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Recruitment Status :
Active, not recruiting
First Posted : May 23, 2017
Last Update Posted : February 15, 2019
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Sponsor:
Calithera Biosciences, Inc
Information provided by (Responsible Party):
Calithera Biosciences, Inc
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Brief Summary:
Phase 2 Study Comparing CB-839 in Combination with Everolimus (CBE) vs. Placebo with Everolimus (PboE) in Patients with Advanced or Metastatic RCC
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Clear Cell Renal Cell Carcinoma | Drug: CB-839 plus everolimus Drug: Placebo plus everolimus | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 63 participants |
| 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) |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Double blinded, placebo-controlled |
| Primary Purpose: | Treatment |
| Official Title: | ENTRATA- 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) |
| Actual Study Start Date : | July 1, 2017 |
| Estimated Primary Completion Date : | December 2019 |
| Estimated Study Completion Date : | December 2020 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Everolimus
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: CB-839 plus everolimus
CBE: CB-839 is administered twice daily in combination with standard doses of everolimus
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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 Name: Afinitor |
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Placebo Comparator: Placebo plus everolimus
PboE: Placebo is administered twice daily in combination with standard doses of everolimus
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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 Name: Afinitor |
Primary Outcome Measures :
- Progression Free Survival (PFS) [ Time Frame: 30 months ]Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary Outcome Measures :
- Overall Survival (OS) [ Time Frame: 42 months ]Assessed by time from randomization to death by any cause
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163667
Locations
Show 38 study locations
Sponsors and Collaborators
Calithera Biosciences, Inc
Investigators
| Study Director: | Sam Whiting | Calithera Biosciences |
Additional Information:
| Responsible Party: | Calithera Biosciences, Inc |
| ClinicalTrials.gov Identifier: | NCT03163667 |
| Other Study ID Numbers: |
CX-839-005 |
| First Posted: | May 23, 2017 Key Record Dates |
| Last Update Posted: | February 15, 2019 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Calithera Biosciences, Inc:
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advanced, metastatic RCC RCC CB-839 Everolimus CBE |
Glutaminase Inhibitor Glutaminase Tumor Metabolism Glutamine |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Sirolimus Everolimus Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents |