Carcinoma, Non-Small Cell Lung
Conditions
Keywords
Stage IIIb/IV non-small cell lung cancer, NSCLC, Lung Cancer
Brief summary
This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.
Interventions
DRUGdocetaxel
Sponsors
Point Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women age 18 years or older * Histologically or cytologically confirmed NSCLC * Recurrent, locally advanced or metastatic, inoperable NSCLC (Stage IIIB/IV) * Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion * Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC * Measurable disease on computerized tomography (CT) scan * ECOG Performance Status of 0 or 1 * Expected survival ≥12 weeks * Provide written informed consent
Exclusion criteria
* More than 2 prior chemotherapy regimens * 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 * Serum creatinine ≥2.0mg/dL * Absolute neutrophil count \<1500/μL or platelets \<100,000/μL * Untreated or symptomatic brain metastases * 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 * A history of severe hypersensitivity to drugs formulated with polysorbate 80 * 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 28 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC. * Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.
Countries
United States
Outcome results
None listed