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Lymphocytic Leukemia, ChronicPhase 2NCT00431873

A Phase II Study of MGCD0103 (MG-0103) in Patients With Refractory Chronic Lymphocytic Leukemia

A Phase 2 study testing MGCD0103 in people with Lymphocytic Leukemia, Chronic, run by Mirati Therapeutics Inc. at 13 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

In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with refractory chronic lymphocytic leukemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphocytic Leukemia, Chronic
What is being tested?
MGCD0103
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
13 sitesin 2 countries
Study dates
Jan 2007to Nov 2008
Phase
Phase 2
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

  • Pathologic confirmation of CLL.
  • Prior Treatment. There will be no limit to prior therapy. Therapy with fludarabine and Rituxan must have failed (disease progression, intolerance, or not a candidate).
  • Age 18 years or greater.
  • ECOG performance status of 0 or 1.
  • Laboratory requirements (must be done within 7 days prior to study initiation):
  • Total Bilirubin ≤ 1.5 x Upper Limit of Normal (ULN).
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  • Aspartate transaminase (AST/SGOT) and Alanine transaminase (ALT/SGPT) ≤ 2.5 x ULN.
  • Serum Creatinine ≤1 .5 x ULN.
  • Patients or their legal representative must be able to read, understand, and sign a written informed consent (approved by the institutional review board/Ethics Committee (IRB/EC)) within 14 days prior to start of treatment.

Who cannot join

  • Patients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia (CIN/cervical in situ) or melanoma in situ). Prior history of cancer is allowed, as long as there is no active disease.
  • Pregnant or lactating women. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test documented within 7 days prior start of study drug.
  • WOCBP and men whose partners are WOCBP must use an acceptable method of contraception while enrolled on this study, and for a period of 3 months following study drug treatment. Patients unwilling or unable to follow this guideline will be excluded. An example of an acceptable form of contraception is a double barrier method, such as condom with diaphragm.
  • Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever > 38.5ºC (not due to tumor fever) on the day of scheduled dosing.
  • Patients with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.
  • Patients who have been treated with any investigational drug within 28 days prior to study initiation (an investigational drug is one for which there is no approved indication), or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy. Patients must have recovered from all transient toxicity induced by prior therapy.
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  • Known hypersensitivity to HDAC inhibitors, to any of the components of MG-0103 (refer to IB). Patients who have known anaphylaxis or IgE-mediated hypersensitivity to murine proteins or to any component of rituximab will not be allowed to receive rituximab concomitantly on this study.
  • Known human immunodeficiency virus (HIV) or known active Hepatitis B or C. Testing is not required for patients not suspected of having these conditions. For patients with a history of Hepatitis B or C that is no longer active, the Investigator should contact MethylGene in advance to confirm patient's eligibility.
  • Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc) that, in the judgment of the investigator, may affect the patient's ability to sign the informed consent and undergo study procedures.
  • Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures. For example, consider requirement to take MG-0103 with a low-pH drink and recommendation to avoid agents that increase gastric-pH.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Canada7 sites

  • Hopital Charles-LeMoyne

    Greenfield Park, Quebec, J4V 2H1

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • McMaster University Health Center

    Hamilton, Ontario, L8N 3Z5

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • CHA, Hopital Enfant-Jesus

    Québec, Quebec, G1J 1Z4

  • UHN - Princess Margaret Hospital

    Toronto, Ontario, M5G 2M6

Other trials in Canada

United States6 sites

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Cleveland Clinic/Chronic Leukemia/Multiple Myeloma Program

    Cleveland, Ohio, 44195

  • Ohio State University, James Cancer Hospital

    Colombus, Ohio, 43210

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Veteran Affairs Medical Center Research Service

    Kansas City, Missouri, 64128

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021-6007

Other trials in United States

About this study

In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with refractory chronic lymphocytic leukemia.

Being tested
MGCD0103
Keywords
Lymphocytic Leukemia, Chronic (Refractory), Phase II
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Lymphoid, Bronchiolitis Obliterans Syndrome

What participants receive

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

  • MGCD0103Drug

    MGCD0103 Administered orally three times per week.

Study groups in NCT00431873
Study groupRoleWhat they receive
1ExperimentalMGCD0103 administered orally three times per week.
Receives: Drug: MGCD0103

What is being measured

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

  1. Response rate

    Measured: 1 year (anticipated)

Secondary outcomes (3)

  1. Duration of objective response

    Measured: 1 year (anticipated)

  2. Safety profile

    Measured: 1 year (anticipated)

  3. Pharmacodynamics (biomarkers)

    Measured: 1 year (anticipated)

Timeline

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

  1. First posted6 Feb 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionNov 2008
  4. Study completionNov 2008

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00431873
Sponsor's protocol ID
0103-009
Status last verified
Jun 2015
First submitted
2 Feb 2007
Last updated
1 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MGCD0103 in people with Lymphocytic Leukemia, Chronic, run by Mirati Therapeutics Inc. at 13 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 9 inclusion and 10 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 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Canada, United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Response rate (time frame: 1 year (anticipated)). 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 NCT00431873.

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 1 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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