Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer

Phase 1

Completed

• Conditions: Lung Cancer
• Interventions: Drug: Obatoclax mesylate 250 ml; Drug: Docetaxel

• Registration Number: NCT00405951
• Lead Sponsor: Gemin X

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

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-30
• Study First Submitted QC: 2006-11-30
• Study First Posted: 2006-12-04
• Primary Completion: 2008-11
• Study Completion: 2009-09
• Disposition First Submitted: 2013-08-16
• Disposition First Submitted QC: 2013-08-16
• Disposition First Posted: 2013-08-26
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Obatoclax Mesylate + Docetaxel	Docetaxel	Obatoclax Mesylate 250mL in combination with Docetaxel
Obatoclax Mesylate + Docetaxel	Obatoclax mesylate 250 ml	Obatoclax Mesylate 250mL in combination with Docetaxel

Primary Outcome Measures

Name	Time	Method
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	18 months	Determine the response rate to obatoclax in combination with docetaxel and characterize the safety profile.; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.

Secondary Outcome Measures

Name	Time	Method
Peripheral blood counts; Bone marrow aspirates and biopsies	18 months

Trial Locations

Locations (7)

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Arlington Cancer Center; 🇺🇸 Arlington, Texas, United States

Mayo Clinic College of Medicine; 🇺🇸 Scottsdale, Arizona, United States

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

Tower Oncology; 🇺🇸 Beverly Hills, California, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

MedStar Research Institute; 🇺🇸 Baltimore, Maryland, United States