Lung Cancer Clinical Trial
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer
Summary
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.
Eligibility Criteria
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
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There are 7 Locations for this study
Scottsdale Arizona, 85259, United States
Beverly Hills California, 90210, United States
Washington District of Columbia, 20007, United States
Tampa Florida, 33612, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21225, United States
Arlington Texas, 76012, United States
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