TRIAL DETAIL

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Drug:
Trial Name:
Study of the Glutaminase Inhibitor CB-839 in Solid Tumors
NCT#:
Conditions:
Solid Tumors
Status:
Active, not recruiting
Phase:
1
Start Date 02/01/2014
Age of Trial (yrs) 5.6
Treatment Phase:
Gleevec-resistant
Drug Category:
SDH-directed
Strategy:
Block related tumor signal paths
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
CX-839-001
Sponsor:
Calithera Biosciences, Inc
Patient Contact:
clinicaltrials@calithera.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
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 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, and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will be enrolled to evaluate the safety and tolerability of standard dose paclitaxel and 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.

Trial Links

Trial Results

 

Drug Information

Calithera Prgrams CB-839
 
2014 AACR Poster
 

Trial Sites

Name
Address
City
State
Zip
Country
1505 Holcombe Blvd.
Houston
TX
77030
USA
Philadelphia
PA
19104
USA
1275 York Ave
New York
NY
10065
USA
1450 3rd St.
San Francisco
CA
94115
USA
Palo Alto
CA
94304
USA
Sarasota
FL
34232
USA
Nashville
TN
37203
USA
1365C Clifton Road
Atlanta
GA
30322
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
330 Brookline Ave.
Boston
MA
02215
USA
55 Fruit Street
Boston
MA
02114
USA
New York
NY
10032
USA
Building 10, Room 1-3750
Bethesda
MD
20814
USA