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Brief Title: Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer
Official Title: 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)
Study ID: NCT00405951
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic College of Medicine, Scottsdale, Arizona, United States
Tower Oncology, Beverly Hills, California, United States
Georgetown University, Washington, 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
Name: Jean Viallet, MD
Affiliation: Gemin X Pharmaceuticals
Role: STUDY_DIRECTOR