A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered Every 3 Weeks in Combination With Docetaxel to Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase I/II Study of Obatoclax Mesylate (GX15-070MS) Administered Every 3 Weeks in Combination With Docetaxel to Patients With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
Inclusion Criteria:
- Pathological confirmation of Non-Small Cell Lung Cancer (NSCLC)
- Must have been previously treated with a single platinum-based chemotherapy regimen
and shown evidence of disease progression; no further limitations
- Must have normal organ function
- Must be willing to submit to blood sampling for planned PK and PD analysis
- Must have the ability to understand and willingness to sign a written informed
consent form
Exclusion Criteria:
- No other agents or therapies administered with the intent to treat malignancy
- Patients with prior exposure to obatoclax or docetaxel
- Uncontrolled, intercurrent illness
- Pregnant women and women who are breast feeding
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
Outcome Measure:
RECIST criteria with at least one lesion equal to or greater than 2.0cm using conventional technique or equal to greater than 1.0cm with spiral comupted tomography (CT) scan in a single dimension
Outcome Description:
Determine the response rate to obatoclax in combination with docetaxel and characterize the safety profile.; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
Outcome Time Frame:
18 months
Safety Issue:
Yes
Principal Investigator
Jean Viallet, MD
Investigator Role:
Study Director
Investigator Affiliation:
Gemin X Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
GEM010
NCT ID:
NCT00405951
Start Date:
October 2006
Completion Date:
September 2009
Related Keywords:
- Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Arlington Cancer Center | Arlington, Texas 76012 |
| Georgetown University | Washington, District of Columbia 20007-2197 |
| H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
| University of Maryland | Baltimore, Maryland 21201 |
| Tower Oncology | Beverly Hills, California 90211 |
| Mayo Clinic College of Medicine | Scottsdale, Arizona 85259 |
| MedStar Research Institute | Baltimore, Maryland 21225 |
