Clinical trial NCT00405951: Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-12-04
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 18 months
Secondary outcomes:
measure: Peripheral blood counts; Bone marrow aspirates and biopsies
timeFrame: 18 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic College of Medicine
state: Arizona
city: Beverly Hills
country: United States
facility: Tower Oncology
state: California
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: MedStar Research Institute
state: Maryland
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
Study officials:
affiliation: Gemin X Pharmaceuticals
name: Jean Viallet, MD
role: STUDY_DIRECTOR
References: