Phase I Clinical Study of MK-0683 in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
20 Years
N/A
Both
Lymphoma
Trial Information
Phase I Clinical Study of MK-0683 in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
Inclusion Criteria
Inclusion Criteria (Parts I & II):
- Patients With CTCL Who Have Progressive, Persistent Or Recurrent Disease Subsequent
To At Least One Prior Therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status Must Be 0-2
- Patients Have Adequate Bone Marrow, Liver Function And Renal Function
Exclusion Criteria (Parts I & II):
- Patients Had Prior Therapy Within 3 Weeks Before Registration, Or Have Not Recovered
From Toxicities Of Prior Therapy
- Patients Have Uncontrolled Intercurrent Illness
- Pregnant Or Women Have A Will To Be Pregnant And Lactating Woman
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)
Outcome Description:
A laboratory AE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body.
Outcome Time Frame:
Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)
Safety Issue:
Yes
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
MK-0683-089
NCT ID:
NCT00771472
Start Date:
August 2008
Completion Date:
July 2011
Related Keywords:
- Lymphoma
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Cutaneous
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