Clinical trial · Interventional
A Research Study for Patients With Metastatic Renal Cell Carcinoma
An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Patients With Metastatic Renal Cell Carcinoma That is Progressive Following or During Immunotherapy
NCT00106613CI-TRIAL-00041201completedPhase 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 activity of FK228 in metastatic renal cell carcinoma (RCC) patients who have developed progressive disease (PD) following or during treatment with immunotherapy.
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 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
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
- 13 mg/m2 of romidepsin
- interventionNames
- Drug: FK228 (romidepsin)
Primary outcomes (1)
- measure
- To evaluate the rate of objective response (the best response of Complete Response (CR), Partial Response (PR)).
- timeFrame
- Up to 6 months
Secondary outcomes (5)
- measure
- Rate of disease control, Complete Response, Partial Response, or Stable Disease
- timeFrame
- Up to 6 months
- measure
- Time to objective disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients must fulfill all of the following criteria to be eligible for study participation: * Age ≥ 18 years; * Histologically confirmed Renal Cell Carcinoma (RCC); * Metastatic disease, with measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST); * Failure of prior cytokine therapy; * Documented progressive disease; Exclusion Criteria: Patients are ineligible for entry if any of the following criteria are met: * Significant cardiac disease including congestive heart failure, history of myocardial infarction within one year, uncontrolled dysrhythmias, or poorly controlled angina * History of serious ventricular arrhythmia * Corrected QT interval (QTc) ≥ 500 msec * Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C; * Previous extensive radiotherapy involving ≥ 30% of bone marrow * Coexistent second malignancy or history of prior malignancy within previous 5 years
References
Publications (6)
- 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
- BACKGROUNDStadler W, et al. A phase II study of depsipeptide (Dep) in patients (pts) with metastatic renal cell cancer (RCC). J Clin Oncol. 2005 Jun; 23(16_suppl):4669.
- RESULTStadler WM, Margolin K, Ferber S, McCulloch W, Thompson JA. A phase II study of depsipeptide in refractory metastatic renal cell cancer. Clin Genitourin Cancer. 2006 Jun;5(1):57-60. doi: 10.3816/CGC.2006.n.018. PMID 16859580