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

Gemin X47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Mayo Clinic College of Medicine

Scottsdale, Arizona, United States

Tower Oncology

Beverly Hills, California, United States

Georgetown University

Washington D.C., 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

Outcomes

Primary Outcomes

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.

Time frame: 18 months

Secondary Outcomes

Peripheral blood counts; Bone marrow aspirates and biopsies

Time frame: 18 months