NCT00358982

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2006

Geographic Reach
2 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

July 3, 2015

Status Verified

June 1, 2015

Enrollment Period

2.4 years

First QC Date

July 31, 2006

Last Update Submit

June 5, 2015

Conditions

Hodgkin's Lymphoma

Keywords

Relapsed or Refractory Hodgkin's LymphomaPhase II

Outcome Measures

Primary Outcomes (1)

  • Success rate

    1 year (anticipated)

Secondary Outcomes (4)

  • Progression-free survival

    1 year (anticipated)

  • Duration of objective response

    1 year (anticipated)

  • Safety profile

    1 year (anticipated)

  • Pharmacodynamics (biomarkers)

    1 year (anticipated)

Study Arms (1)

1

EXPERIMENTAL
Drug: MGCD0103

Interventions

MGCD0103DRUG

MGCD0103 administered orally three times per wek

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (1)

  • 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.

    PMID: 22033282DERIVED

MeSH Terms

Conditions

Hodgkin DiseaseRecurrence

Interventions

mocetinostat

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gregory Reid, MSc, MBA

    MethylGene Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2006

First Posted

August 1, 2006

Study Start

August 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

July 3, 2015

Record last verified: 2015-06

Locations

CA(2)US(3)