Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106301
• Other study ID #: FJ-228-0007
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2004
• Est. completion date: September 1, 2006

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a Phase II, non-randomized, open-label, single arm, continuation trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 1, 2006
• Est. primary completion date: September 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital	Sutton
United States	University of Chicago	Chicago	Illinois
United States	City of Hope National Medical Center	Duarte	California
United States	University of Florida	Gainesville	Florida
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  United Kingdom, 

References & Publications (4)

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. — View Citation

Moreno L, Casanova M, Chisholm JC, Berlanga P, Chastagner PB, Baruchel S, Amoroso L, Gallego Melcón 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		Up to 6 months
Secondary	To evaluate the effect of depsipeptide therapy on performance status as measured by the Karnofsky score assessment		Up to 6 months
Secondary	To evaluate the time to objective disease progression.		Up to 6 months