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

Gemin X

Status and phase

Completed

Phase 2

Phase 1

Conditions

Lung Cancer

Treatments

Drug: Docetaxel

Drug: Obatoclax mesylate 250 ml

Study type

Interventional

Funder types

Industry

Identifiers

NCT00405951

GEM010

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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