Study of MGCD0103 Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma

Lymphoma Clinical Trial

Official title:

A Phase II Study of MGCD0103 (MG-0103) Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359086
• Other study ID #: 0103-008
• Status: Completed
• Phase: Phase 2
• First received: July 31, 2006
• Last updated: June 4, 2015
• Start date: August 2006
• Est. completion date: January 2012

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

In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with relapsed and refractory lymphoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathologic confirmation of relapsed or refractory lymphoma.

1. DLBCL stage II-IV

2. Follicular lymphoma

• At least one site of measurable disease (= 2.0 cm with conventional techniques; physical exam [PE], CT, X-ray, MRI).

• Prior treatment:

1. DLBCL cohort: Disease progression following initial therapy and transplant (unless the patient is ineligible or refused transplant). There is no limit to number of prior therapies.

2. Follicular lymphoma cohort: Follicular lymphoma that is relapsed following or refractory to standard therapy and/or existing therapies or are not eligible for or are unlikely to achieve clinical benefit from those therapies. Patients must have failed 3 or more prior therapies.

• Must have at least one of the following considered related to disease:

1. Local symptoms due to progressive or bulky nodal disease.

2. Compromise of normal organ function due to progressive or bulky disease.

3. Presence of systemic B symptoms.

4. Presence of symptomatic extranodal disease.

5. Cytopenias due to extensive bone marrow infiltration, autoimmune hemolytic anemia or thrombocytopenia, or hypersplenism.

• ECOG performance status of 0 or 1.

• Aged 18 years or older.

• Laboratory requirements.

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.

• Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever >38.5 Celsius (not due to tumor fever) on the day of scheduled dosing.

• Patients with a history of pericardial disease.

• Patients with small, moderate or large pericardial effusions or patients with a diagnosis of pericarditis.

• Patients with significant cardiac abnormalities.

• Patients with serious illnesses, medical conditions, or other medical history which would be likely to interfere with 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.

• Known hypersensitivity to HDAC inhibitors and to any components of MGCD0103.

• Known human immunodeficiency virus (HIV) or active Hepatitis B or C.

• Central nervous system lymphoma and lymphoma involving leptomeningeal area.

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

• Lymphoma

Intervention

Drug:
• MGCD0103
MGCD0103 given orally three times per week

Locations

Country	Name	City	State
Canada	Charles LeMoyne Hospital	Greenfield Park	Quebec
Canada	Sir Mortimer Davis-Jewish General Hospital	Montreal	Quebec
Canada	Ottawa Hospital - General Campus	Ottawa	Ontario
United States	Duke University Adult Bone Marrow Transplant Clinic	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas

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	Response 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	Pharmacokinetics		1 year (anticipated)	No
Secondary	Pharmacodynamics		1 year (anticipated)	No