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

Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405951
• Other study ID #: GEM010
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 30, 2006
• Last updated: July 19, 2016
• Start date: October 2006
• Est. completion date: September 2009

Study information

• Verified date: July 2016
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Obatoclax mesylate 250 ml

• Docetaxel

Locations

Country	Name	City	State
United States	Arlington Cancer Center	Arlington	Texas
United States	MedStar Research Institute	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Tower Oncology	Beverly Hills	California
United States	Mayo Clinic College of Medicine	Scottsdale	Arizona
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Gemin X

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine the response rate to obatoclax in combination with docetaxel and characterize the safety profile.; Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.	18 months	Yes
Secondary	Peripheral blood counts; Bone marrow aspirates and biopsies		18 months	No