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

Phase 2

Terminated

• Conditions: Hodgkin's Lymphoma
• Interventions: Drug: MGCD0103

• Registration Number: NCT00358982
• Lead Sponsor: Mirati Therapeutics Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-31
• Study First Submitted QC: 2006-07-31
• Study Start: 2006-08
• Study First Posted: 2006-08-01
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2015-06
• Disposition First Submitted: 2015-06-05
• Disposition First Submitted QC: 2015-06-05
• Last Update Submitted: 2015-06-05
• Disposition First Posted: 2015-07-03
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MGCD0103	-

Primary Outcome Measures

Name	Time	Method
Success rate	1 year (anticipated)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	1 year (anticipated)
Duration of objective response	1 year (anticipated)
Pharmacodynamics (biomarkers)	1 year (anticipated)
Safety profile	1 year (anticipated)

Trial Locations

Locations (5)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada