Status:
TERMINATED
Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Lead Sponsor:
Mirati Therapeutics Inc.
Conditions:
Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00358982
Start Date
August 1 2006
End Date
January 1 2009
Last Update
July 3 2015
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
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