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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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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
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.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

PTH-302

NCT ID:

NCT00080080

Start Date:

Completion Date:

Related Keywords:

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

Name

Location

Mary Crowley Medical Research CenterDallas, Texas  75246
Tyler Cancer CenterTyler, Texas  75702
Cancer Care NorthwestSpokane, Washington  99202
University of ChicagoChicago, Illinois  60637
Cancer Center of FloridaOcoee, Florida  34761
Van Elslander Cancer CenterGrosse Pointe Woods, Michigan  48236
New York Oncology/Hematology--Albany Regional Cancer CenterAlbany, New York  12208
Mt. Sinai School of MedicineNew York, New York  10029
USB Cancer Center-- Nyack HospitalNyack, New York  10960
Dayton Oncology & HematologyKettering, Ohio  45409