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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00080080
• Date of registration: 23/03/2004
• Primary sponsor: Point Therapeutics
• Public title: Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
• Scientific title: Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
• Date of first enrolment: March 2004
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00080080
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lung Cancer

Intervention(s)

Drug: Docetaxel

Drug: talabostat (PT-100) tablets

Secondary ID(s)

PTH-302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors