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

Sponsor
Mirati Therapeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00359086
Collaborator
(none)
74
5
1
65
14.8
0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
74 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) Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma
Study Start Date :
Aug 1, 2006
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: MGCD0103
MGCD0103 given orally three times per week

Outcome Measures

Primary Outcome Measures

  1. Response rate [1 year (anticipated)]

Secondary Outcome Measures

  1. Progression-free survival [1 year (anticipated)]

  2. Duration of objective response [1 year (anticipated)]

  3. Safety profile [1 year (anticipated)]

  4. Pharmacokinetics [1 year (anticipated)]

  5. Pharmacodynamics [1 year (anticipated)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Adult Bone Marrow Transplant Clinic Durham North Carolina United States 27710
2 MD Anderson Cancer Center Houston Texas United States 77030
3 Ottawa Hospital - General Campus Ottawa Ontario Canada K1H 8L6
4 Charles LeMoyne Hospital Greenfield Park Quebec Canada J4V 2H1
5 Sir Mortimer Davis-Jewish General Hospital Montreal Quebec Canada H3T 1E2

Sponsors and Collaborators

  • Mirati Therapeutics Inc.

Investigators

  • Study Director: Gregory Reid, MSc, MBA, MethylGene Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00359086
Other Study ID Numbers:
  • 0103-008
First Posted:
Aug 1, 2006
Last Update Posted:
Jul 1, 2015
Last Verified:
Jun 1, 2015
Keywords provided by Mirati Therapeutics Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2015