Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • NF1 Mutation Positive Malignant Peripheral Nerve Sheath Tumor
  • Unresectable Malignant Solid Neoplasm
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVE: I. To assess the best overall response rate (BORR) achieved by 6 months of telaglenastat hydrochloride (CB-839 HCl) treatment in specific pathway aberrant tumors (MPNST, NF1, KEAP1/NRF2 & STK11/ LKB1). SECONDARY OBJECTIVES: I. To determine the safety, progression-free survival (PF...

PRIMARY OBJECTIVE: I. To assess the best overall response rate (BORR) achieved by 6 months of telaglenastat hydrochloride (CB-839 HCl) treatment in specific pathway aberrant tumors (MPNST, NF1, KEAP1/NRF2 & STK11/ LKB1). SECONDARY OBJECTIVES: I. To determine the safety, progression-free survival (PFS), time to progression (TTP) and overall survival (OS). II. To determine the overall response rate (ORR) (highest objective response achieved between start of therapy and progression), time to response (TTR) and clinical benefit rate (CBR) of CB-839 HCl. III. To assess pharmacodynamic changes and adaptive responses and correlate with response to treatment as well as disease progression (correlative objective). EXPLORATORY OBJECTIVES: I. Correlate fludeoxyglucose F-18 (18-F FDG) positron emission tomography (PET)/computed tomography (CT) pre-therapy and 8-weeks post-therapy response to CB-839 HCl therapy. II. Evaluate changes in level of circulating tumor deoxyribonucleic acid (DNA) at baseline, one month on-treatment and time of progression to treatment response. III. Quantify the peripheral blood concentrations of the metabolites: aspartate, glutamate, glutamine and arginine and correlate with response. IV. Evaluate the pharmacodynamic (PD) effect of CB-839 HCl on systemic levels of the tricarboxylic acid (TCA) cycle metabolites in peripheral blood (baseline and one month) as part of the protocol. V. Evaluate tumor by reverse phase protein array and ribonucleic acid (RNA) sequencing (seq) to evaluate changes from pre-treatment, during treatment and post treatment specimens. VI. Perform patient-derived tumor xenograft (PDX) modelling-co-clinical trials to understand response/resistance mechanisms and also evaluate combination therapies for future development. OUTLINE: Patients receive telaglenastat hydrochloride orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months thereafter.

Tracking Information

NCT #
NCT03872427
Collaborators
Not Provided
Investigators
Principal Investigator: Vivek Subbiah University of Texas MD Anderson Cancer Center LAO