|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
16 December 2019 |
|
Main ID: |
EUCTR2004-001907-36-GB |
|
Date of registration:
|
10/02/2005 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients with Relapsed Diffuse Large B-Cell Lymphoma (DLBCL) - L-001079038 in Relapsed DLBCL
|
|
Scientific title:
|
A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (L-001079038) in Patients with Relapsed Diffuse Large B-Cell Lymphoma (DLBCL) - L-001079038 in Relapsed DLBCL |
|
Date of first enrolment:
|
18/03/2005 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001907-36 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: no
Open: yes
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
|
|
Phase:
|
Human pharmacology (Phase I):
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV):
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Eligible patients must be =18 years with relapsed DLBCL (de novo or transformed)following standard first line chemotherapy and at least one salvage systemic therapy. Patients who have disease that is refractory to their last chemotherapy regimen are not eligible. Other eligibility criteria include: 3 months or longer without evidence of progression on the most recent treatment; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2; = 4 weeks from prior chemotherapy, radiation therapy, major surgery, or other investigational anticancer therapy; and adequate hematologic (absolute neutrophil count >1000/mm3, platelets > 75,000 /mm3), hepatic and renal function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Patients to be excluded from the trial if:
had prior treatment with any HDAC inhibitor (e.g., Depsipeptide, MS-275, LAQ 824);
had a response or stable disease less than 3 m to the most recent treatment;
have failed more than 3 prior regimens ;
have had an allogenenic transplantation.
have certain co-mobility including HIV infection.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
|
Relapsed Diffuse Large B-Cell Lymphoma
|
|
Intervention(s)
|
Product Name: suberoylanilide hydroxamic acid (SAHA)
Product Code: MK-0683/L-001079038
Pharmaceutical Form: Capsule*
|
|
Primary Outcome(s)
|
|
Primary end point(s): The primary efficacy endpoint is ORR based on PET and CT scan findings in patients with measurable disease defined as those that can be accurately measured in at least one dimension of ?2 cm by conventional CT scan.
|
|
Secondary Objective: To assess response duration (RD), progression-free survival time (PFS), time to progression, time to response, and progression free survival rate at 3 months and 6 months; and to assess the safety of oral SAHA in this patient population.
|
|
Main Objective: To determine the anti-tumor effectiveness of oral suberoylanilide hydroxamic acid (SAHA) as measured by overall objective response rate (ORR) in patients with relapsed DLBCL (de novo or transformed).
|
|
Secondary ID(s)
|
|
0683 013-02
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
|