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

Conditions

• Carcinoma, Non-Small Cell Lung
• Non-Small-Cell Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Entinostat — DRUG
  Entinostat tablets on Days 1 and 15 of a 28-day cycle.
• Placebo — DRUG
  Placebo-matching entinostat tablets on Days 1 and 15 of a 28-day cycle.
• Erlotinib — DRUG
  Erlotinib 150 mg tablets once daily.

Study Details

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).

Key Dates

First listed

Jan 28, 2008

Start date

Jan 8, 2008

Status verified

Aug 2022

Primary completion

Feb 4, 2010

Completion

Feb 1, 2012

Study Design

Enrollment

141 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lead-in Phase: Erlotinib + Entinostat 5 mg
  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.
• Experimental: Lead-in Phase: Erlotinib + Entinostat 10 mg
  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.
• Experimental: Double-blind Phase: Erlotinib + Entinostat 10 mg
  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.
• Placebo Comparator: Double-blind Phase: Erlotinib + Placebo
  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.
• Experimental: Crossover Phase: Erlotinib + Entinostat 10 mg
  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.

Primary Outcome Measure

Identification of Safe-dose for the Phase 2 Double-blind Phase in the Lead-in Phase [ Time Frame: Cycle 1 of Lead-in Phase ]

Locations (30)

Find similar trials in Tucson, AZ

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