Expired Study
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Grosse Pointe Woods, Michigan 48236


Purpose:

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.


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.


Study is Available At:


Original ID:

PTH-302


NCT ID:

NCT00080080


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Point Therapeutics


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Study Dates

Verification Date:June 2007
Last Changed Date:June 7, 2007
First Received Date:March 23, 2004

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:talabostat (PT-100) tablets
Intervention Type:Drug
Name:Docetaxel

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Point Therapeutics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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