Back to resultsContinuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228
Primary Purpose
Carcinoma, Renal Cell, Prostatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FK228 (romidepsin)
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring FK228, Hormone Refractory Prostate Cancer
Eligibility Criteria
Inclusion Criteria: Patient has completed 6 cycles of therapy in a prior Fujisawa-sponsored FK228 clinical trial; Patient has immediate past participation (not to exceed 21 days from Day 15 of cycle 6 in the previous study) in a prior Fujisawa-sponsored FK228 clinical trial; Patient has demonstrated stable disease, partial response or complete response as best overall response in their prior Fujisawa-sponsored FK228 clinical trial. Exclusion Criteria: Patient has been on a prior Fujisawa-sponsored FK228 clinical trial, left the trial and then received alternative anti-neoplastic therapy
Sites / Locations
- City of Hope National Medical Center
- University of Florida
- University of Chicago
- Seattle Cancer Care Alliance
- Royal Marsden Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FK228 (romidepsin)
Arm Description
romidepsin
Outcomes
Primary Outcome Measures
Number of participants with adverse events
Secondary Outcome Measures
To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment
To evaluate the time to objective disease progression.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00106301
Brief Title
Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228
Official Title
A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Have Completed a Prior Clinical Study With FK228
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2004 (Actual)
Primary Completion Date
September 1, 2006 (Actual)
Study Completion Date
September 1, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of extended treatment with FK228 in patients with metastatic renal cell carcinoma or hormone refractory prostate cancer who have at least demonstrated stable disease on prior Fujisawa sponsored FK228 clinical trials.
Detailed Description
This is a Phase II, non-randomized, open-label, single arm, continuation trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Renal Cell, Prostatic Neoplasms
Keywords
FK228, Hormone Refractory Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FK228 (romidepsin)
Arm Type
Experimental
Arm Description
romidepsin
Intervention Type
Drug
Intervention Name(s)
FK228 (romidepsin)
Other Intervention Name(s)
romidepsin
Intervention Description
Patients were continued at the same dose of romidepsin as in the previous study, which could have been 13 mg/m2 or a reduced dose of 10 mg/m2, administered intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment
Time Frame
Up to 6 months
Title
To evaluate the time to objective disease progression.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has completed 6 cycles of therapy in a prior Fujisawa-sponsored FK228 clinical trial;
Patient has immediate past participation (not to exceed 21 days from Day 15 of cycle 6 in the previous study) in a prior Fujisawa-sponsored FK228 clinical trial;
Patient has demonstrated stable disease, partial response or complete response as best overall response in their prior Fujisawa-sponsored FK228 clinical trial.
Exclusion Criteria:
Patient has been on a prior Fujisawa-sponsored FK228 clinical trial, left the trial and then received alternative anti-neoplastic therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William McCulloch, MB, FRCP
Organizational Affiliation
Gloucester Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29936064
Citation
Moreno L, Casanova M, Chisholm JC, Berlanga P, Chastagner PB, Baruchel S, Amoroso L, Gallego Melcon S, Gerber NU, Bisogno G, Fagioli F, Geoerger B, Glade Bender JL, Aerts I, Bergeron C, Hingorani P, Elias I, Simcock M, Ferrara S, Le Bruchec Y, Slepetis R, Chen N, Vassal G. Phase I results of a phase I/II study of weekly nab-paclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer. Eur J Cancer. 2018 Sep;100:27-34. doi: 10.1016/j.ejca.2018.05.002. Epub 2018 Jun 21.
Results Reference
background
PubMed Identifier
30500529
Citation
Wolchok J. Putting the Immunologic Brakes on Cancer. Cell. 2018 Nov 29;175(6):1452-1454. doi: 10.1016/j.cell.2018.11.006.
Results Reference
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PubMed Identifier
30446588
Citation
Mansfield AS, Jen J. Predicting Treatment Response Based on RNA Expression in Large Datasets. Clin Cancer Res. 2019 Mar 1;25(5):1443-1445. doi: 10.1158/1078-0432.CCR-18-2823. Epub 2018 Nov 16.
Results Reference
background
PubMed Identifier
30624766
Citation
Pal SK, Forero-Torres A, Thompson JA, Morris JC, Chhabra S, Hoimes CJ, Vogelzang NJ, Boyd T, Bergerot PG, Adashek JJ, Li H, Yu X, Gartner EM, Carret AS, Smith DC. A phase 1 trial of SGN-CD70A in patients with CD70-positive, metastatic renal cell carcinoma. Cancer. 2019 Apr 1;125(7):1124-1132. doi: 10.1002/cncr.31912. Epub 2019 Jan 9.
Results Reference
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Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228
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