We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    CB-839 lung

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

This study is currently recruiting participants.
Verified August 2016 by Calithera Biosciences, Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT02071862
First Posted: February 26, 2014
Last Update Posted: August 22, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Calithera Biosciences, Inc
February 14, 2014
February 26, 2014
August 22, 2016
February 2014
June 2017   (Final data collection date for primary outcome measure)
Safety and tolerability of CB-839: Incidence of adverse events [ Time Frame: Every 21 days from study start until disease progression or unacceptable toxicity, assessed for an expected average of 6 months ]
Same as current
Complete list of historical versions of study NCT02071862 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics: Area under the Curve (AUC) of CB-839 concentration in blood [ Time Frame: Study Days 1, 15, and 22 ]
  • Pharmacodynamics: % inhibition of glutaminase in blood [ Time Frame: Study Days 1 and 15 ]
  • Clinical activity: Change in tumor volume from baseline [ Time Frame: Every 9 weeks until disease progression or unacceptable toxicity, assessed for an expected average of 6 months ]
Same as current
Not Provided
Not Provided
 
Study of the Glutaminase Inhibitor CB-839 in Solid Tumors
Ph1 Study of the Safety, PK, and PDn of Escalating Oral Doses of the Glutaminase Inhibitor CB-839, as a Single Agent and in Combination With Standard Chemotherapy in Patients With Advanced and/or Treatment-Refractory Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. To exploit the dependence of tumors on glutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this Phase 1 study in patients with solid tumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solid tumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrolling patients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839 capsules orally twice or three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-Negative Breast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D) Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors, H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, and I) cMyc mutation tumors.

As an extension of Parts 1 & 2, patients will be treated with CB-839 in combination with standard chemotherapy. Combination groups include: Pac-CB, CBE, CB-Erl, CBD, and CB-Cabo. Pac-CB: patients with locally-advanced or metastatic TNBC will be treated with paclitaxel and CB-839. CBE: patients with advanced clear cell RCC or papillary RCC will be treated with everolimus in combination with CB-839. CB-Erl: patients with advanced NSCLC lacking the T790M EGFR mutation will be treated with erlotinib and CB-839. CBD: patients with NSCLC harboring KRAS mutation will be treated with docetaxel and CB-839. CB-Cabo: patients with histologically confirmed diagnosis of locally-advanced, inoperable or metastatic RCC treated with cabozantinib in combination with CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may predict responsiveness in later studies), and tumor response.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Solid Tumors
  • Triple-Negative Breast Cancer
  • Non Small Cell Lung Cancer
  • Renal Cell Carcinoma
  • Mesothelioma
  • Fumarate Hydratase (FH)-Deficient Tumors
  • Succinate Dehydrogenase (SDH)-Deficient Gastrointestinal Stromal Tumors (GIST)
  • Succinate Dehydrogenase (SDH)-Deficient Non-gastrointestinal Stromal Tumors
  • Tumors Harboring Isocitrate Dehydrogenase-1 (IDH1) and IDH2 Mutations
  • Tumors Harboring Amplifications in the cMyc Gene
  • Drug: CB-839
    CB-839 monotherapy
    Other Name: Glutaminase Inhibitor
  • Drug: Pac-CB
    CB-839 in combination with standard dose paclitaxel
    Other Name: combo CB-839 and Paclitaxel
  • Drug: CBE
    CB-839 in combination with standard dose everolimus
    Other Name: combo CB-839 and everolimus
  • Drug: CB-Erl
    CB-839 in combination with standard dose erlotnib
    Other Name: combo CB-839 and erlotnib
  • Drug: CBD
    CB-839 in combination with standard dose docetaxel
    Other Name: combo CB-839 and docetaxel
  • Drug: CB-Cabo
    CB-839 in combination with standard dose cabozantinib
    Other Name: combo CB-839 and cabozantinib
  • Experimental: CB-839
    CB-839 administered as oral capsules two (BID) or three times daily (TID) in 21-day cycles until disease progression or unacceptable toxicity
    Intervention: Drug: CB-839
  • Experimental: Pac-CB
    CB-839 administered as oral capsules twice daily (BID) in combination with standard dose paclitaxel in 28-day cycles until disease progression or unacceptable toxicity
    Interventions:
    • Drug: CB-839
    • Drug: Pac-CB
  • Experimental: CBE
    CB-839 administered as oral capsules twice daily (BID) in combination with standard dose everolimus in 28-day cycles until disease progression or unacceptable toxicity
    Interventions:
    • Drug: CB-839
    • Drug: CBE
  • Experimental: CB-Erl
    CB-839 administered as oral capsules twice daily (BID) in combination with standard dose erlotnib in 28-day cycles until disease progression or unacceptable toxicity
    Interventions:
    • Drug: CB-839
    • Drug: CB-Erl
  • Experimental: CBD
    CB-839 administered as oral capsules twice daily (BID) in combination with standard dose docetaxel in 21-day cycles until disease progression or unacceptable toxicity
    Interventions:
    • Drug: CB-839
    • Drug: CBD
  • Experimental: CB-Cabo
    CB-839 administered as oral capsules twice daily (BID) in combination with standard dose cabozantinib in 28-day cycles until disease progression or unacceptable toxicity
    Intervention: Drug: CB-Cabo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
205
September 2017
June 2017   (Final data collection date for primary outcome measure)

Inclusion criteria

  • Advanced malignancy that is relapsed and/or refractory to all available therapies that will confer clinical benefit. Newly diagnosed patients who refuse standard treatment regimens are also eligible
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Life Expectancy of at least 3 months
  • Adequate hepatic, renal, cardiac, and hematologic function
  • Measurable disease by RECIST criteria
  • Ability to provide written informed consent in accordance with federal, local, and institutional guidelines

Exclusion Criteria

  • Any other current or previous malignancy
  • Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological therapy, or investigational agent within 21 days
  • Unable to receive medications oral medications
  • Major surgery within 28 days before Cycle 1 Day 1
  • Active infection requiring within 2 weeks prior to first dose of study drug
  • Patients who have HIV, Hepatitis A, B or C or CMV reactivation
  • Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose of study drug
  • Conditions that could interfere with treatment or protocol-related procedures
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Clinical Administrator clinicaltrials@calithera.com
United States
 
 
NCT02071862
CX-839-001
No
Not Provided
Not Provided
Calithera Biosciences, Inc
Calithera Biosciences, Inc
Not Provided
Study Director: Samuel Whiting, MD, PhD Calithera Biosciences, Inc
Calithera Biosciences, Inc
August 2016

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