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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Obatoclax Mesylate + Docetaxel

Obatoclax Mesylate 250mL in combination with Docetaxel

Group Type EXPERIMENTAL

Obatoclax mesylate 250 ml

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Interventions

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Obatoclax mesylate 250 ml

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No