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

Tracking Information
First Received Date ^ICMJE	October 18, 2002
Last Updated Date	January 10, 2008
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00047801 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel in Platinum-Resistant Non-Small Cell Lung Cancer
Official Title ^ICMJE	Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Docetaxel (Taxotere) in Platinum-Resistant Non-Small Cell Lung Cancer
Brief Summary	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
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Carcinoma, Non-Small-Cell Lung
Intervention ^ICMJE	Drug: TLK286 in combination with docetaxel
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	28
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00047801
Responsible Party
Study ID Numbers ^ICMJE	TLK286.2012
Study Sponsor ^ICMJE	Telik
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Telik
Verification Date	February 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP