Clinical trial · Interventional
Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228
A Multicenter, Open-Label Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Have Completed a Prior Clinical Study With FK228
NCT00106301CI-TRIAL-00041715completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FK228 (romidepsin) | Drug | Romidepsin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FK228 (romidepsin)
- description
- romidepsin
- interventionNames
- Drug: FK228 (romidepsin)
Primary outcomes (1)
- measure
- Number of participants with adverse events
- timeFrame
- Up to 6 months
Secondary outcomes (2)
- measure
- To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment
- timeFrame
- Up to 6 months
- measure
- To evaluate the time to objective disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDMoreno 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. PMID 29936064
- BACKGROUNDWolchok J. Putting the Immunologic Brakes on Cancer. Cell. 2018 Nov 29;175(6):1452-1454. doi: 10.1016/j.cell.2018.11.006. PMID 30500529
- BACKGROUNDMansfield 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. PMID 30446588
- BACKGROUNDPal 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. PMID 30624766