- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00047801
Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel in Platinum-Resistant Non-Small Cell Lung Cancer
July 21, 2011 updated by: Telik
Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel (Taxotere) in Platinum-Resistant Non-Small Cell Lung Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
28
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA Medical Center
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Los Angeles, California, United States, 90025
- Cancer Institute Medical Group
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Cancer Center
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Texas
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Houston, Texas, United States, 77030
- M.D. Anderson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria include:
- 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 include:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Primary Completion (Actual)
September 1, 2004
Study Completion (Actual)
September 1, 2004
Study Registration Dates
First Submitted
October 18, 2002
First Submitted That Met QC Criteria
October 18, 2002
First Posted (Estimate)
October 21, 2002
Study Record Updates
Last Update Posted (Estimate)
July 25, 2011
Last Update Submitted That Met QC Criteria
July 21, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- TLK286.2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Norwegian Breast Cancer GroupCompletedBreast NeoplasmNorway
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Yonsei UniversityWithdrawn
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Shen LinUnknownColorectal Cancer | Esophageal Squamous Cell Carcinoma | Biliary Tract Cancer | Targeted Therapy | HER2China
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Hunan Province Tumor HospitalNot yet recruitingNon-Small Cell Lung CancerChina
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AkesoNot yet recruiting
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Sun Yat-sen UniversityRecruitingPeripheral T-cell LymphomaChina
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Aurora Health CareRecruiting