Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel in Platinum-Resistant Non-Small Cell Lung Cancer

NCT ID: NCT00047801

Last Updated: 2011-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2004-09-30

Brief Summary

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The purpose of this study is to determine the effectiveness and safety of TLK286 given intravenously once every three weeks in combination with docetaxel (Taxotere) in the treatment of patients with non-small cell lung cancer that is resistant to platinum-based chemotherapy.

Detailed Description

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Conditions

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Carcinoma, Non-small-cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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TLK286 in combination with docetaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed non-small cell bronchogenic carcinoma, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma with squamous cell carcinoma), bronchoalveolar carcinoma, or large cell carcinoma
* Stage IV or Stage IIIB
* Progressed during or after first-line therapies with platinum-containing regimens in the advanced or metastatic treatment regimen
* At least 18 years of age
* Good performance status (ECOG 0 to 1)
* Adequate liver, renal, and bone marrow function

Exclusion Criteria

* Pregnant or lactating women
* Treatment with more than one cytotoxic therapy
* Prior radiation to the whole pelvis
* Unstable medical conditions such as uncontrolled cardiac arrhythmia
* Patients with known history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Telik

INDUSTRY

Sponsor Role lead

Responsible Party

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Telik, Inc.

Locations

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Cancer Institute Medical Group

Los Angeles, California, United States

Site Status

UCLA Medical Center

Los Angeles, California, United States

Site Status

Indiana University Cancer Center

Indianapolis, Indiana, United States

Site Status

M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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TLK286.2012

Identifier Type: -

Identifier Source: org_study_id

NCT00068705

Identifier Type: -

Identifier Source: nct_alias

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