Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer
Completed · Phase 1/Phase 2
Conditions studied: Lung Cancer
In brief
Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells. This is a multi-center, open-label, Phase I/II study of obatoclax administered in combination with docetaxel in 3-week cycles to patients with relapsed or refractory Non-Small Cell Lung Cancer. Treatment may be administered on an outpatient basis. No investigation or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Non-Small Cell Lung Cancer are allowed.
Key facts
- Study ID
- NCT00405951
- Run by
- Gemin X
- People needed
- 47
- Starts
- 2006-10-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2016-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic College of Medicine — Scottsdale, Arizona, United States
- Tower Oncology — Beverly Hills, California, United States
- Georgetown University — Washington D.C., District of Columbia, United States
- H. Lee Moffitt Cancer Center — Tampa, Florida, United States
- University of Maryland — Baltimore, Maryland, United States
- MedStar Research Institute — Baltimore, Maryland, United States
- Arlington Cancer Center — Arlington, Texas, United States
Full record on ClinicalTrials.gov
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