NCT00431873

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2007

Geographic Reach
2 countries

13 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

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

1.8 years

First QC Date

February 2, 2007

Last Update Submit

June 4, 2015

Conditions

Lymphocytic Leukemia, Chronic

Keywords

Lymphocytic Leukemia, Chronic (Refractory)Phase II

Outcome Measures

Primary Outcomes (1)

  • Response rate

    1 year (anticipated)

Secondary Outcomes (3)

  • Duration of objective response

    1 year (anticipated)

  • Safety profile

    1 year (anticipated)

  • Pharmacodynamics (biomarkers)

    1 year (anticipated)

Study Arms (1)

1

EXPERIMENTAL

MGCD0103 administered orally three times per week.

Drug: MGCD0103

Interventions

MGCD0103DRUG

MGCD0103 Administered orally three times per week.

1

Eligibility Criteria

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

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Veteran Affairs Medical Center Research Service

Kansas City, Missouri, 64128, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021-6007, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Cleveland Clinic/Chronic Leukemia/Multiple Myeloma Program

Cleveland, Ohio, 44195, United States

Location

Ohio State University, James Cancer Hospital

Colombus, Ohio, 43210, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

McMaster University Health Center

Hamilton, Ontario, L8N 3Z5, Canada

Location

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

UHN - Princess Margaret Hospital

Toronto, Ontario, M5G 2M6, Canada

Location

Hopital Charles-LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

CHA, Hopital Enfant-Jesus

Québec, Quebec, G1J 1Z4, Canada

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemia, LymphoidBronchiolitis Obliterans Syndrome

Interventions

mocetinostat

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host Disease

Study Officials

  • Gregory Reid, MSc, MBA

    MethylGene Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2007

First Posted

February 6, 2007

Study Start

January 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

July 1, 2015

Record last verified: 2015-06

Locations

US(6)CA(7)