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

Sponsor

Mirati Therapeutics Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00431873

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lymphocytic Leukemia, Chronic	Drug: MGCD0103	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 MGCD0103 administered orally three times per week.	Drug: MGCD0103 MGCD0103 Administered orally three times per week.

Arm

Intervention/Treatment

Experimental: 1

MGCD0103 administered orally three times per week.

Drug: MGCD0103

MGCD0103 Administered orally three times per week.

Outcome Measures

Primary Outcome Measures

Response rate [1 year (anticipated)]

Secondary Outcome Measures

Duration of objective response [1 year (anticipated)]
Safety profile [1 year (anticipated)]
Pharmacodynamics (biomarkers) [1 year (anticipated)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veteran Affairs Medical Center Research Service	Kansas City	Missouri	United States	64128
2	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021-6007
3	Gabrail Cancer Center	Canton	Ohio	United States	44718
4	Cleveland Clinic/Chronic Leukemia/Multiple Myeloma Program	Cleveland	Ohio	United States	44195
5	Ohio State University, James Cancer Hospital	Colombus	Ohio	United States	43210
6	MD Anderson Cancer Center	Houston	Texas	United States	77030
7	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 2Y9
8	McMaster University Health Center	Hamilton	Ontario	Canada	L8N 3Z5
9	Ottawa Hospital - General Campus	Ottawa	Ontario	Canada	K1H 8L6
10	UHN - Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M6
11	Hopital Charles-LeMoyne	Greenfield Park	Quebec	Canada	J4V 2H1
12	Hopital Maisonneuve-Rosemont	Montreal	Quebec	Canada	H1T 2M4
13	CHA, Hopital Enfant-Jesus	Quebec		Canada	G1J 1Z4