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

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ClinicalTrials.gov Identifier: NCT00358982
Recruitment Status : Terminated
First Posted : August 1, 2006
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE July 31, 2006
First Posted Date  ICMJE August 1, 2006
Last Update Posted Date July 3, 2015
Study Start Date  ICMJE August 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2007)
Success rate [ Time Frame: 1 year (anticipated) ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
  • Estimate the success rate (SD + PR + CR) with MG-0103 in patients with relapsed or refractory classical Hodgkin's lymphoma using physical exam
  • Imaging studies to evaluate disease (eg, CT, MRI)
  • Bone marrow biopsy
  • PET scan
Change History Complete list of historical versions of study NCT00358982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2007)
  • Progression-free survival [ Time Frame: 1 year (anticipated) ]
  • Duration of objective response [ Time Frame: 1 year (anticipated) ]
  • Safety profile [ Time Frame: 1 year (anticipated) ]
  • Pharmacodynamics (biomarkers) [ Time Frame: 1 year (anticipated) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
  • Estimate duration of objective response
  • Estimate progression-free survival
  • Characterize the safety profile of MG-0103
  • Assess biomarkers and predictive markers for efficacy or toxicity of MG-0103
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Official Title  ICMJE A Phase II Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin's Lymphoma
Intervention  ICMJE Drug: MGCD0103
MGCD0103 administered orally three times per wek
Study Arms  ICMJE Experimental: 1
Intervention: Drug: MGCD0103
Publications * Younes A, Oki Y, Bociek RG, Kuruvilla J, Fanale M, Neelapu S, Copeland A, Buglio D, Galal A, Besterman J, Li Z, Drouin M, Patterson T, Ward MR, Paulus JK, Ji Y, Medeiros LJ, Martell RE. Mocetinostat for relapsed classical Hodgkin's lymphoma: an open-label, single-arm, phase 2 trial. Lancet Oncol. 2011 Dec;12(13):1222-8. doi: 10.1016/S1470-2045(11)70265-0. Epub 2011 Oct 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 5, 2015)
51
Original Enrollment  ICMJE
 (submitted: July 31, 2006)
35
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00358982
Other Study ID Numbers  ICMJE 0103-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mirati Therapeutics Inc.
Study Sponsor  ICMJE Mirati Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
PRS Account Mirati Therapeutics Inc.
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP