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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02071888
Other study ID # CX-839-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 2014
Est. completion date April 2016

Study information

Verified date July 2018
Source Calithera Biosciences, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 advanced hematologic malignancies.

This study is an open-label Phase 1 evaluation of CB-839 in subjects with hematological tumors. Patients will receive CB-839 capsules orally two or three times daily. The study will be conducted in 2 parts. Part 1 is a dose escalation study to identify the recommended Phase 2 dose and will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM)

In Part 2, all patients will receive the recommended Phase 2 dose. This part will enroll patients with advanced and/or treatment-refractory Non-Hodgkin's Lymphoma (NHL), Multiple Myeloma (MM), or Waldenström's macroglobulinemia (WM). 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.

As an extension of Part 2, a cohort of patients with relapsed and refractory MM will be enrolled to receive low dose dexamethasone and CB-839. A second cohort of patients with relapsed or refractory disease following at least 2 prior treatment regimens will be enrolled to receive CB-839 in combination with standard-dose pomalidomide and low-dose dexamethasone to further evaluate this triple combination.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Disease-Specific Inclusion Criteria

Patients must have one of the following diseases that is either relapsed or refractory to 2 or more prior treatments:

- NHL: At least one measurable lesion

- WM: Measurable IgM, with a minimum level of = 2x ULN

- MM: Serum M-protein = 0.5 g/dL and/or urine M-protein = 200 mg/24 hr. In Part 2, disease that is considered measurable per the IMWG criteria

Other Inclusion Criteria

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

- Life Expectancy of at least 3 months

- Adequate hepatic, renal, cardiac and hematological function

Exclusion Criteria

- Any other current malignancy

- Treatment with an unapproved, investigational therapeutic agent, immunotherapy or biological therapy within 21 days prior to the first dose of study drug

- Recent bone marrow transplant

- Unable to receive medications by mouth

- Major surgery within 28 days before the first dose of study drug

- Uncontrolled, active infection; patients who are known to have HIV infection/ seropositivity, Hepatitis A, B, or C, or CMV reactivation

- Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days prior to the first dose of study drug

- Refractory nausea and vomiting or other situation that may preclude adequate absorption

- Other conditions that could interfere with treatment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CB-839
Glutaminase inhibitor
CB-839 and low dose dexamethasone
CB-839 and low dose dexamethasone
CB-839, pomalidomide, and low dose dexamethasone
CB-839, pomalidomide, and low dose dexamethasone

Locations

Country Name City State
United States Winship Cancer Institute of Emory School of Medicine Atlanta Georgia
United States Colorado Blood Cancer Institute Denver Colorado
United States John Theruer Cancer Center at Hackensack University Medical Center Hackensack New Jersey
United States Tennessee Oncology, PLLC Nashville Tennessee
United States Weill Cornell Medical College New York New York
United States University of Pennsylvania, Abramson Cancer Center Philadelphia Pennsylvania
United States Mayo Clinic Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
Calithera Biosciences, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of CB-839: Incidence of adverse events Every 21 days from study start until disease progression or unacceptable toxicity, assessed for an expected average of 6 months
Secondary Pharmacokinetics: Area under the Curve (AUC) of CB-839 concentration in blood Study Days 1, 15, and 22
Secondary Pharmacodynamics: % inhibition of glutaminase in blood Study Days 1 and 15
Secondary Clinical activity: Change in tumor size from baseline Every 9 weeks (NHL) or 3 weeks (MM and WM), assessed for an expected average of 6 months
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