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

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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

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

- 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.

Type of Study:


Study Design:

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


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

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



Mary Crowley Medical Research Center Dallas, Texas  75246
Tyler Cancer Center Tyler, Texas  75702
Cancer Care Northwest Spokane, Washington  99202
University of Chicago Chicago, Illinois  60637
Cancer Center of Florida Ocoee, Florida  34761
Van Elslander Cancer Center Grosse Pointe Woods, Michigan  48236
New York Oncology/Hematology--Albany Regional Cancer Center Albany, New York  12208
Mt. Sinai School of Medicine New York, New York  10029
USB Cancer Center-- Nyack Hospital Nyack, New York  10960
Dayton Oncology & Hematology Kettering, Ohio  45409