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NCT00602030 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Erlotinib With or Without SNDX-275 (Entinostat) in the Treatment of Patients With Advanced NSCLC
A Phase 1 study of Carcinoma, Non-Small Cell Lung and Non-Small-Cell Lung Carcinoma, sponsored by Syndax Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 141
- Enrollment target
- 20
- Study locations
NCT00602030: Completed Phase 1 study of Carcinoma, Non-Small Cell Lung and Non-Small-Cell Lung Carcinoma, sponsored by Syndax Pharmaceuticals.
NCT00602030 is a Phase 1 study of Carcinoma, Non-Small Cell Lung and Non-Small-Cell Lung Carcinoma that has completed, run by Syndax Pharmaceuticals. The registered enrollment target is 141 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00602030, a Phase 1 study of Carcinoma, Non-Small Cell Lung and Non-Small-Cell Lung Carcinoma, has completed, sponsored by Syndax Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 141 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
Safe recommended Phase 2 dose was determined based on dose-limiting toxicities (DLT) in Cycle 1. A DLT was defined as any of the following occurring in Cycle 1: Grade 3 or greater nonhematologic toxicity that was considered related to either entinostat or erlotinib or a Grade 4 hematologic toxicity lasting more than 7 days and/or resulting in a dose delay. Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 scale was used where Grade 1=mild, Grade 2=Moderate, Grade 3=Severe, medic
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Entinostat
- DRUG Erlotinib
Study Locations (20)
Texas
- Texas Oncology - Amarillo
- Texas Oncology - Austin
- Texas Oncology - Bedford
- Texas Oncology, Sammons Cancer Center - Dallas
- Texas Oncology - Dallas
- Texas Oncology - Fort Worth
Florida
- Advanced Medical Specialties - Miami
- Ocala Oncology Center - Ocala
- Cancer Centers of Florida - Ocoee
Missouri
- St Joseph Oncology - Saint Joseph
- The Center for Cancer Care & Research - St Louis
Ohio
- Mahonig Valley Hematology Oncology Associates - Boardman
- Dayton Oncology & Hematology - Kettering
Arizona
- HOPE (Hematology Oncology Physicians & Extenders) - Tucson
Colorado
- Rocky Mountain Cancer Center - Denver
Illinois
- Hematology Oncology Associates of Illinois - Chicago
Indiana
- Central Indiana Cancer Centers - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2008-01-08 |
| Est. Completion | 2012-02-01 |
| Phase | Phase 1 |
What the finished NCT00602030 record still lists
NCT00602030 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (56% lower).
The record links to 2 conditions, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00602030 names 20 study sites across 11 states, led by Texas, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT00602030 about?
NCT00602030 is a clinical study titled "Study to Evaluate Erlotinib With or Without SNDX-275 (Entinostat) in the Treatment of Patients With Advanced NSCLC". 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).
What is the current status of trial NCT00602030?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 141 participants. The study started on 2008-01-08. Estimated completion is 2012-02-01.
What conditions does trial NCT00602030 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung, Non-Small-Cell Lung Carcinoma.
What interventions are being tested in trial NCT00602030?
The interventions under investigation include: Placebo (DRUG), Entinostat (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT00602030?
This trial is sponsored by Syndax Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00602030 being conducted?
This trial has 20 study locations across Arizona, Colorado, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Carcinoma, Non-Small Cell Lung
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00602030's enrollment target sits among peer trials
141 59th of 130 higher than 72 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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