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NCT00411632 · ClinicalTrials.gov registry record · Phase 2

BATTLE Program: Tarceva and Targretin in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
37
Enrollment target

NCT00411632: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00411632 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00411632, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
37 participants
Enrollment target

Study Summary

The goal of this clinical research study is to evaluate the effectiveness of Tarceva® (OSI-774, erlotinib hydrochloride) in combination with Targretin® (bexarotene) in treating NSCLC. The safety of this treatment will also be studied, as well as the treatment's effect on different cells in the body and the participants' overall response.

Primary Outcome

The primary objective is to determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced NSCLC who have failed at least one prior chemotherapy regimen. A radiologist independently assessed DC, which was defined as a complete or partial response or stable disease according to the RECIST(29) at the end of 8 weeks (start of treatment to end of second treatment cycle). PFS was assessed from the date of randomization to the earliest sign of disease progres

Interventions

  • DRUG Bexarotene
  • DRUG Erlotinib

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2006-11-29
Est. Completion 2018-02-23
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00411632 record still lists

NCT00411632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 2 interventions - of which Bexarotene is the first listed.

NCT00411632 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00411632 about?

NCT00411632 is a clinical study titled "BATTLE Program: Tarceva and Targretin in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)". The goal of this clinical research study is to evaluate the effectiveness of Tarceva® (OSI-774, erlotinib hydrochloride) in combination with Targretin® (bexarotene) in treating NSCLC. The safety of this treatment will also be studied, as well as the treatment's effect on different cells in the body ...

What is the current status of trial NCT00411632?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2006-11-29. Estimated completion is 2018-02-23.

What interventions are being tested in trial NCT00411632?

The interventions under investigation include: Bexarotene (DRUG), Erlotinib (DRUG).

Who is sponsoring clinical trial NCT00411632?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00411632's enrollment target sits among peer trials

37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00411632, the US trial registry maintained by the National Library of Medicine. NCT00411632 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.