Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Sponsor

Mirati Therapeutics Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00358982

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

10.2

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

MGCD0103 is an experimental drug that belongs to a class of drugs known as the histone deacetylase inhibitors, which may restore normal control in cancer cells by affecting the genes and proteins that are being made. Laboratory tests show that this new investigational anti-cancer drug can slow down the growth of human cancer cells in mice; two clinical research studies are currently being performed in humans with cancer and a similar study is being performed in patients with the same disease.

The purpose of this study is to find out what effect the experimental drug MGCD0103 has on patients with relapsed and refractory Hodgkin's lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin's Lymphoma	Drug: MGCD0103	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

51 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 Relapsed or Refractory Hodgkin's Lymphoma

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: MGCD0103 MGCD0103 administered orally three times per wek

Arm

Intervention/Treatment

Experimental: 1

Drug: MGCD0103

MGCD0103 administered orally three times per wek

Outcome Measures

Primary Outcome Measures

Success rate [1 year (anticipated)]

Secondary Outcome Measures

Progression-free survival [1 year (anticipated)]
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 relapsed or refractory classical Hodgkin's lymphoma.
The patient has at least one site of measurable disease (≥ 2.0 cm) as measured by conventional techniques such as CT or MRI.
Prior treatment: there is no limit to number of prior therapies. Patients who had prior allogeneic stem cell transplants and do not have evidence of graft versus host disease and are not receiving immunosuppressive agents are eligible if they meet all other inclusion criteria.
ECOG performance status of 0 or 1.
Aged 18 years or older (no safety data yet for ages < 18).
Laboratory requirements (must be done within 7 days prior to study initiation).

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 to start of study drug.
WOCBP and men whose partners are WOCBP must use an acceptable method of contraception while enrolled in this study, and for a period of 3 months following study drug treatment.
Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever > 38.5°C (not due to tumor fever) on the day of scheduled dosing.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612
2	Nebraska Medical Center	Omaha	Nebraska	United States	68198
3	MD Anderson Cancer Center	Houston	Texas	United States	77030
4	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
5	Royal Victoria Hospital	Montreal	Quebec	Canada	H3A 1A1