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

May 9, 2014 updated by: Gemin X

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of CA- San Diego
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Lombardi Cancer Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S Hershey Medical Center Penn State Cancer Institute
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Obatoclax
Drug: GX15-070MS
GX15-070MS at various doses and schedules
Other Names:
  • Obatoclax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gemin X

Investigators

  • Study Director: Jean Viallet, MD, Gemin X, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

January 15, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Estimate)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GX004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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