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

Lung Cancer Clinical Trial

Official title:

Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00080080
• Other study ID #: PTH-302
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2004
• Last updated: June 7, 2007

Study information

• Verified date: June 2007
• Source: Point Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• talabostat (PT-100) tablets

• Docetaxel

Locations

Country	Name	City	State
United States	New York Oncology/Hematology--Albany Regional Cancer Center	Albany	New York
United States	University of Chicago	Chicago	Illinois
United States	Mary Crowley Medical Research Center	Dallas	Texas
United States	Van Elslander Cancer Center	Grosse Pointe Woods	Michigan
United States	Dayton Oncology & Hematology	Kettering	Ohio
United States	Mt. Sinai School of Medicine	New York	New York
United States	USB Cancer Center-- Nyack Hospital	Nyack	New York
United States	Cancer Center of Florida	Ocoee	Florida
United States	Cancer Care Northwest	Spokane	Washington
United States	Tyler Cancer Center	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Point Therapeutics

Country where clinical trial is conducted

United States,