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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 belowSelect...
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.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 months
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 moreOther 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking part in another study with a new or experimental treatment.There is no information about the effects of CB-839 HCl (telaglenastat) and MLN0128 (sapanisertib) on a growing baby in the womb.You cannot swallow pills.You have a serious heart or lung condition that is currently active.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.You have had an allergic reaction to drugs that are similar to CB-839 HCl (telaglenastat) and MLN0128 (sapanisertib).You have a medical condition that affects how your body absorbs MLN0128 (sapanisertib). This condition could be due to prior gastrointestinal (GI) surgery, GI disease or for an unknown reason.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CB-839 HCl, sapanisertib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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