Carcinoma, Renal Cell, Prostatic Neoplasms
Conditions
Keywords
FK228, Hormone Refractory Prostate Cancer
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.
Interventions
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.
Sponsors
Celgene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | Up to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment | Up to 6 months |
| To evaluate the time to objective disease progression. | Up to 6 months |
Countries
United Kingdom, United States
Outcome results
None listed