NCT00405951

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1 lung-cancer

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

2.1 years

First QC Date

November 30, 2006

Last Update Submit

July 19, 2016

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Peripheral blood counts; Bone marrow aspirates and biopsies

    18 months

Study Arms (1)

Obatoclax Mesylate + Docetaxel

EXPERIMENTAL

Obatoclax Mesylate 250mL in combination with Docetaxel

Drug: Obatoclax mesylate 250 mlDrug: Docetaxel

Interventions

Obatoclax mesylate 250 mlDRUG
Obatoclax Mesylate + Docetaxel
DocetaxelDRUG
Obatoclax Mesylate + Docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mayo Clinic College of Medicine

Scottsdale, Arizona, 85259, United States

Location

Tower Oncology

Beverly Hills, California, 90210, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MedStar Research Institute

Baltimore, Maryland, 21225, United States

Location

Arlington Cancer Center

Arlington, Texas, 76012, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

obatoclaxDocetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Jean Viallet, MD

    Gemin X Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

October 1, 2006

Primary Completion

November 1, 2008

Study Completion

September 1, 2009

Last Updated

July 21, 2016

Record last verified: 2016-07

Locations

US(7)