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Kinase Inhibitor

Treatment (CB-839 HCl, sapanisertib) for Lung Cancer

Phase 1
Recruiting
Led By Jonathan W Riess
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
The effects of CB-839 HCl (telaglenastat) and MLN0128 (sapanisertib) on the developing human fetus are unknown
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 months
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of two drugs, CB-839 HCl and sapanisertib, when given together to treat patients with non-small cell lung cancer that has spread to other places in the body.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that worsened after platinum-based chemotherapy or PD-(L)1 inhibitors. Participants must have specific mutations if they've had targeted therapies, manageable brain metastases, and meet certain health criteria like stable blood sugar and organ function. Pregnant women, those unable to swallow pills, or with severe illnesses are excluded.Check my eligibility
What is being tested?
The trial tests the safety and optimal doses of two anti-cancer drugs: CB-839 HCl (Telaglenastat) and MLN0128 (Sapanisertib), when used together in patients with NSCLC. These drugs aim to block enzymes essential for tumor cell growth.See study design
What are the potential side effects?
Potential side effects include issues affecting digestion, liver function changes, fatigue, blood sugar alterations, possible allergic reactions similar to other compounds in these drugs' class. The exact side effects will be monitored as part of determining the safest doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You may have had another type of cancer before or currently have another type of cancer, but it must not interfere with the safety or effectiveness of the study treatment.
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There is no information about the effects of CB-839 HCl (telaglenastat) and MLN0128 (sapanisertib) on a growing baby in the womb.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose/recommended phase II dose of MLN0128 (sapanisertib) and CB-839 HCl (telaglenastat) in combination (dose-escalation)
Median progression free survival (PFS) (dose-expansion)
Response rate (dose-expansion)
Secondary outcome measures
Disease control rate (DCR)
Cognitive Therapy
Objective response rate (ORR)
+1 more
Other outcome measures
Genomic and metabolic signatures

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (CB-839 HCl, sapanisertib)Experimental Treatment2 Interventions
Patients receive glutaminase inhibitor CB-839 hydrochloride PO BID and sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sapanisertib
2016
Completed Phase 2
~840

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,750 Total Patients Enrolled
Jonathan W RiessPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
4 Previous Clinical Trials
249 Total Patients Enrolled

Media Library

Sapanisertib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04250545 — Phase 1
Lung Cancer Research Study Groups: Treatment (CB-839 HCl, sapanisertib)
Lung Cancer Clinical Trial 2023: Sapanisertib Highlights & Side Effects. Trial Name: NCT04250545 — Phase 1
Sapanisertib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04250545 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~11 spots leftby Sep 2024