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Trial record 1 of 1 for:    CX839-012
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A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT03965845
Recruitment Status : Completed
First Posted : May 29, 2019
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
Calithera Biosciences, Inc

Tracking Information
First Submitted Date  ICMJE May 24, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date October 29, 2021
Actual Study Start Date  ICMJE June 25, 2019
Actual Primary Completion Date September 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • Safety and Tolerability of telaglenestat (CB-839) in combination with palbociclib: (CR) number of participants with treatment related adverse events [ Time Frame: Start of treatment to 28 days post treatment ]
    Number of participants with treatment related adverse events as assessed by CTCAE v5.0
  • Maximum tolerated dose and/or Recommended Phase 2 Dose: [ Time Frame: Measured from Part 1 patients only within their first 28 day cycle ]
    Incidence and nature of dose-limiting toxicities
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • Maximum plasma concentration of telaglenastat and palbociclib: [ Time Frame: PKs are drawn on two different days (Day 8 and Day 15) during Cycle 1 ]
    Non-compartmental method of analysis will be used to analyze the plasma concentrations
  • Anti-tumor activity of telaglenestat and palbociclib: [ Time Frame: Approximately every 8 weeks until disease progression, for approximately 18 months ]
    Change in tumor size from baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors
Official Title  ICMJE A Phase 1b/2, Open Label, Dose Escalation and Expansion Study of the Glutaminase Inhibitor Telaglenastat (CB-839) in Combination With CDK4/6 Inhibitor Palbociclib in Patients With Advanced or Metastatic Solid Tumors
Brief Summary This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor telaglenestat (CB-839) with the CDK4/6 Inhibitor, palbociclib in participants with advanced/metastatic solid tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumors
  • NSCLC
  • CRC
  • KRAS Gene Mutation
Intervention  ICMJE
  • Drug: Telaglenestat (CB-839)
    Teleglenastat is an oral tablet administered twice daily with food at the assigned dose level. Dose is taken with palbociclib each day in 28-day cycles.
  • Drug: Palbociclib Oral Capsule or Tablet [Ibrance]
    Palbociclib (Ibrance) is an oral capsule or tablet administered once daily with food on Days 1-21 of every 28-day cycle in combination with telaglenestat. Days 22-28 of every cycle, palbociclib is not taken.
    Other Name: Ibrance
Study Arms  ICMJE
  • Experimental: Cohort 1: Telaglenastat 600 mg and Palbociclib 75 mg
    Interventions:
    • Drug: Telaglenestat (CB-839)
    • Drug: Palbociclib Oral Capsule or Tablet [Ibrance]
  • Experimental: Cohort 2: Telaglenastat 800 mg and Palbociclib 75 mg
    Interventions:
    • Drug: Telaglenestat (CB-839)
    • Drug: Palbociclib Oral Capsule or Tablet [Ibrance]
  • Experimental: Cohort 3: Telaglenastat 800 mg and Palbociclib 100 mg
    Interventions:
    • Drug: Telaglenestat (CB-839)
    • Drug: Palbociclib Oral Capsule or Tablet [Ibrance]
  • Experimental: Cohort 3: Telaglenastat 800 mg and Palbociclib 125 mg
    Interventions:
    • Drug: Telaglenestat (CB-839)
    • Drug: Palbociclib Oral Capsule or Tablet [Ibrance]
  • Experimental: Part 2: Expansion
    The recommended phase 2 dose (RP2D) determined from Part 1 will be the treatment for all cohorts in expansion Part 2.
    Interventions:
    • Drug: Telaglenestat (CB-839)
    • Drug: Palbociclib Oral Capsule or Tablet [Ibrance]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2021)
53
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2019)
85
Actual Study Completion Date  ICMJE September 24, 2021
Actual Primary Completion Date September 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Part 1: Have documented incurable/locally advanced or metastatic solid tumors that have either relapsed or are refractory or intolerant to the standard therapies of proven clinical benefit.
  • Part 2: Availability of archival tumor tissue block or slides (Fresh tumor biopsy will be required if archival tissue is not available)
  • Part 2, Cohort 1: Incurable/locally advanced or metastatic KRAS-mutant CRC previously treated with systemic therapy (examples include: oxaliplatin-, irinotecan-and 5 FU-based chemotherapy (unless contraindicated) with or without bevacizumab)
  • Part 2, Cohort 2: Incurable/locally advanced or metastatic KRAS-mutant NSCLC previously treated with systemic chemotherapy including platinum-based and anti-PD-1/PDL-1 therapy (unless contraindicated)
  • Part 2, Cohort 3: Advance KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC) harboring a mutation or loss in CDKN2A (PDAC) and received treatment with one or more lines of systemic chemotherapy with FOLFIRINOX and/or gemcitabine/abraxane in the neoadjuvant, adjuvant, or metastatic disease setting or unable to receive standard of care chemotherapy

Cohort 4 may be opened only if Cohort 3 achieves predefined criteria for efficacy

-Part 2 Cohort 4: Advanced KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC). · Histological or cytological diagnosis of advanced or metastatic KRAS-mutant with CDKN2A wild type (PDAC) and received treatment with one or more lines of systemic chemotherapy with FOLFIRINOX and/or gemcitabine/abraxane in the neoadjuvant, adjuvant, or metastatic disease setting or unable to receive standard of care chemotherapy.

For both Part 1 and 2:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Ability to provide written consent in accordance with federal, local and institutional guidelines
  • PER RECIST v1.1 evaluable disease (for part 1) or measurable disease (for Part 2)
  • Recovery to baseline or to Grade 1 CTCAE v5.0 of toxicities that were related to prior therapies

Exclusion Criteria:

  • Prior treatment with CB-839 or palbociclib
  • Unable to receive oral medication
  • Infection requiring more than 5 days of parenteral antibiotics, antivirals, or antifungals within two weeks prior to C1D1
  • Unable to discontinue proton pump inhibitor use before study treatment
  • Refractory nausea and vomiting, uncontrolled diarrhea, malabsorption, significant small bowel resection or gastric bypass surgery, use of feeding tubes or other situation that may preclude adequate absorption
  • Active and/or untreated central nervous system metastasis. Patients with treated brain metastasis must have (1) documented radiographic stability of at least 4 weeks in duration demonstrating on baseline central nervous system imaging prior to study treatment and (2) be symptomatically stable and off steroids for at least 2 weeks before administration of any study treatment.
  • Major surgery within 28 days prior to first dose of study drug
  • Receipt of any anticancer therapy within the following windows:

    1. small molecule TKI therapy (including investigational) within 2 weeks or 5 half-lives prior to expected Cycle 1 Day 1 dose
    2. any type of anti-cancer antibody or cytotoxic chemo within 4 weeks prior to Cycle 1 Day 1 Dose
    3. radiation therapy for bone metastasis within 2 weeks prior or any other external radiation therapy within 4 weeks prior to C1D1
    4. patients with clinically relevant ongoing complications from prior radiation therapy are not eligible
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03965845
Other Study ID Numbers  ICMJE CX-839-012
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Calithera Biosciences, Inc
Study Sponsor  ICMJE Calithera Biosciences, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Emil Kuriakose, MD Calithera Biosciences, Inc
PRS Account Calithera Biosciences, Inc
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP