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Chronic Lymphocytic LeukemiaPhase 1NCT00600964

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

A Phase 1 study testing GX15-070MS in people with Chronic Lymphocytic Leukemia, run by Gemin X at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
GX15-070MS
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
5 sitesin 2 countries
Study dates
Sep 2004to Jan 2006
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • Milton S Hershey Medical Center Penn State Cancer Institute

    Hershey, Pennsylvania, 17033

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of CA- San Diego

    La Jolla, California, 92093

  • Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

Canada1 site

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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)

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

Read the detailed description

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

Being tested
GX15-070MS
Keywords
CLL, obatoclax
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GX15-070MSDrug

    Also called Obatoclax

    A 60-minute or 3-hour IV infusion every 2-3 weeks.

  • GX15-070MSDrug

    Also called Obatoclax

    GX15-070MS at various doses and schedules

Study groups in NCT00600964
Study groupRoleWhat they receive
GX15-070MSExperimentalGX15-070MS at various doses and schedules
Receives: Drug: GX15-070MS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the recommended Phase II dose of GX15-070MS administered as a 60-minute and/or 3-hour infusion every 2 to 3 weeks

    Measured: 14 days

Secondary outcomes (1)

  1. 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.

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2008 (estimated)
  2. Study startSep 2004
  3. Primary completionJan 2006
  4. Study completionJan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00600964
Sponsor's protocol ID
GX004
Status last verified
May 2014
First submitted
15 Jan 2008
Last updated
12 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • O'Brien SM, Claxton DF, Crump M, Faderl S, Kipps T, Keating MJ, Viallet J, Cheson BD. Phase I study of obatoclax mesylate (GX15-070), a small molecule pan-Bcl-2 family antagonist, in patients with advanced chronic lymphocytic leukemia. Blood. 2009 Jan 8;113(2):299-305. doi: 10.1182/blood-2008-02-137943. Epub 2008 Oct 17.

    PubMed 18931344

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GX15-070MS in people with Chronic Lymphocytic Leukemia, run by Gemin X at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00600964, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2014.

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