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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

47

Study ID:

NCT00405951

Recruitment Status:

Completed

Sponsor:

Gemin X

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There are 7 Locations for this study

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Mayo Clinic College of Medicine
Scottsdale Arizona, 85259, United States
Tower Oncology
Beverly Hills California, 90210, United States
Georgetown University
Washington District of Columbia, 20007, United States
H. Lee Moffitt Cancer Center
Tampa Florida, 33612, United States
University of Maryland
Baltimore Maryland, 21201, United States
MedStar Research Institute
Baltimore Maryland, 21225, United States
Arlington Cancer Center
Arlington Texas, 76012, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

47

Study ID:

NCT00405951

Recruitment Status:

Completed

Sponsor:


Gemin X

How clear is this clinincal trial information?

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