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

Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00358982
• Other study ID #: 0103-010
• Status: Terminated
• Phase: Phase 2
• First received: July 31, 2006
• Last updated: June 5, 2015
• Start date: August 2006
• Est. completion date: January 2009

Study information

• Verified date: June 2015
• Source: Mirati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Drug:
• MGCD0103
MGCD0103 administered orally three times per wek

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Rush University Medical Center	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas
United States	Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Mirati Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate		1 year (anticipated)	No
Secondary	Progression-free survival		1 year (anticipated)	Yes
Secondary	Duration of objective response		1 year (anticipated)	No
Secondary	Safety profile		1 year (anticipated)	Yes
Secondary	Pharmacodynamics (biomarkers)		1 year (anticipated)	No