A Phase I/II Study of GX15-070MS in Untreated CLL

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00600964
First received: January 15, 2008
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

This protocol is being run to determine the best phase II dose and schedule of obatoclax in patients with previously untreated CLL.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: GX15-070MS
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Phase I/II Study of Single-Agent GX15-070MS Administered Every 2 to 3 Weeks to Patients With Previously-Treated Chronic Lymphocytic Leukemia (CLL)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Estimate the response rate of previously-treated patients with CLL at the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: September 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GX15-070MS
GX15-070MS at various doses and schedules
Drug: GX15-070MS
A 60-minute or 3-hour IV infusion every 2-3 weeks.
Other Name: Obatoclax
Drug: GX15-070MS
GX15-070MS at various doses and schedules
Other Name: Obatoclax

Detailed Description:

Both 1 hour and 3 hour infusions of obatoclax every 3 weeks will be evaluated in ascending doses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed B-CLL
  • Previous standard systemic chemotherapy, including fludarabine. There are no limitations on additional, allowable type and amount of prior therapy. Acute toxicities from prior therapy must have resolved to ≤Grade 1
  • Age ≥18 years
  • ECOG Performance Status ≤1
  • Life expectancy of >8 weeks

Exclusion Criteria:

  • Patients receiving any other investigational agents (e.g., under another IND) or commercial agents or therapies administered with the intent to treat their malignancy
  • Patients with history of seizure disorders
  • Pregnant women and women who are breast feeding
  • HIV-positive patients receiving combination anti-retroviral therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600964

Locations
United States, California
University of CA- San Diego
La Jolla, California, United States, 92093
United States, District of Columbia
Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
United States, Pennsylvania
Milton S Hershey Medical Center Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Gemin X
Investigators
Study Director: Jean Viallet, MD Gemin X, Inc.
  More Information

Publications:
Responsible Party: Jean Viallet, MD, Gemin X, Inc.
ClinicalTrials.gov Identifier: NCT00600964     History of Changes
Other Study ID Numbers: GX004
Study First Received: January 15, 2008
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Teva Pharmaceutical Industries:
CLL
obatoclax

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014