Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer

This study has been completed.

Sponsor:

Information provided by:

Point Therapeutics

ClinicalTrials.gov Identifier:

NCT00080080

First received: March 23, 2004

Last updated: June 7, 2007

Last verified: June 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	March 23, 2004
Last Updated Date	June 7, 2007
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 NCT00080080 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
Official Title ^ICMJE	Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
Brief Summary	The purpose of this study is to determine the antitumor activity (response rate, time to tumor progression, survival) and safety of docetaxel in combination with talabostat in patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior platinum-containing regimen.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Lung Cancer
Intervention ^ICMJE	Drug: talabostat (PT-100) tablets Drug: Docetaxel
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Histologically or cytologically confirmed Stage IIIb/IV NSCLC Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC Measurable disease ECOG Performance Status of 0 or 1 Expected survival ≥12 weeks Provide written informed consent Exclusion Criteria: More than 2 prior chemotherapy regimens Brain metastases (exception: patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month) Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy A history of severe hypersensitivity reactions to drugs formulated with polysorbate 80 A history of myocardial infarction within 1 year of study entry, CABG within 6 months of study entry, severe congestive heart failure (ejection fraction <30%), history of ventricular arrhythmia, or other uncontrolled cardiac arrhythmia Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment in order to be enrolled. Pregnant or lactating women. Clinically significant laboratory abnormalities, specifically: Total bilirubin ≥institutional upper limit of normal (ULN); Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN; Hepatitis B surface antigen or antibody to Hepatitis C (anti-HCV antibody); Serum creatinine ≥2.0mg/dL; or Granulocytes <1500/μL or platelets <100,000/μL.
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 Number ^ICMJE	NCT00080080
Other Study ID Numbers ^ICMJE	PTH-302
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Point Therapeutics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Point Therapeutics
Verification Date	June 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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