A Phase 2 interventional study of FK228 (romidepsin) in Carcinoma, Renal Cell and Prostatic Neoplasms, sponsored by Celgene. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-18.
Sponsored by Celgene · Phase 2, Interventional, and Treatment
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.
This is a Phase II, non-randomized, open-label, single arm, continuation trial.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 2 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
romidepsin
Drug: FK228 (romidepsin)
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.
Also known as: romidepsin
Number of participants with adverse events
Time frame: Up to 6 months
To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment
Time frame: Up to 6 months
To evaluate the time to objective disease progression.
Time frame: Up to 6 months
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Celgene