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

Point Therapeutics

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Drug: Docetaxel

Drug: talabostat (PT-100) tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00080080

PTH-302

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.