Study to Evaluate Erlotinib With or Without SNDX-275 (Entinostat) in the Treatment of Patients With Advanced NSCLC

Recruiting in Palo Alto (17 mi)

+33 other locations

Overseen bySamir Witta, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Syndax Pharmaceuticals

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and efficacy of entinostat in combination with erlotinib in the treatment of Advanced Non-Small Cell Lung Cancer (NSCLC).

Research Team

Robert Raju, MD

Principal Investigator

Dayton Oncology

Kartik Konduri, MD

Principal Investigator

Texas Oncology - Sammons Cancer Center

Samir Witta, MD

Principal Investigator

Rocky Mountain Cancer Centers

Eligibility Criteria

Inclusion Criteria

Bilirubin and creatinine less than 2 times the upper limit of normal for the institution

Albumin ≥ 2.5 g/dL

Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 times the upper limit of normal for the institution

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Treatment Details

Interventions

Entinostat (Histone Deacetylase Inhibitor)
Erlotinib (Tyrosine Kinase Inhibitor)

Participant Groups

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Lead-in Phase: Erlotinib + Entinostat 5 mgExperimental Treatment2 Interventions

Erlotinib 150 mg, tablets, orally, daily plus entinostat 5 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.

Group II: Lead-in Phase: Erlotinib + Entinostat 10 mgExperimental Treatment2 Interventions

Erlotinib 150 mg tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Lead-in Phase.

Group III: Double-blind Phase: Erlotinib + Entinostat 10 mgExperimental Treatment2 Interventions

Erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Day 1 and 15 of a 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.

Group IV: Crossover Phase: Erlotinib + Entinostat 10 mgExperimental Treatment2 Interventions

Participants in the Double-blind Phase Erlotinib + Placebo arm who experienced disease progression crossed over to receive open-label erlotinib 150 mg, tablets, orally, daily plus entinostat 10 mg, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities.

Group V: Double-blind Phase: Erlotinib + PlaceboPlacebo Group2 Interventions

Erlotinib 150 mg, tablets, orally, daily plus placebo matching entinostat, tablets, orally, on Days 1 and 15 of each 28-day cycle until disease progression or intolerable toxicities for up to 6 cycles in the Double-blind Phase.

Erlotinib is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Tarceva for: