A Research Study for Patients With Prostate Cancer

NCT00106418 | Completed Phase 2

• 1 other identifier: FJ-228-0002
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the activity of romidepsin (depsipeptide,FK228) in patients with metastatic prostate cancer who have developed a rising prostate specific antigen (PSA) while undergoing hormonal therapy.

Conditions

Prostate Cancer; Metastases

Keywords

Prostate Cancer; Androgen independent metastatic prostate cancer patients with rising PSA; romidepsin

Outcome Measures

Primary Outcomes (1)

• Rate of objective disease control

  Rate of objective disease control was defined as the proportion of patients with confirmed CR, PR, or SD for at least 6 months, as determined by the Response Evaluation Criteria for Solid Tumors (RECIST).

  Up to 6 months

Study Arms (1)

Romidepsin

EXPERIMENTAL

13 mg/m\^2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.

Drug: Romidepsin

Interventions

Romidepsin DRUG

13 mg/m2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.

Also known as: Istodax, depsipeptide, FK 228

Romidepsin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males ≥18 years;
• Written informed consent/authorization;
• Histological or cytological confirmation of metastatic prostate cancer with documented progression on hormonal therapy (objective progressive disease \[PD\], new bone lesions, or stable soft tissue or bone lesions with PSA increase);
• Patients must have either measurable disease or bone metastasis. Patients with measurable disease are preferred;
• Rising PSA, with a minimum study entry PSA of ≥5 ng/mL;
• Karnofsky performance status of ≥80%;
• Life expectancy of \>12 weeks;
• For patients treated with anti-androgens, elevation of PSA must be demonstrated after cessation of anti-androgen treatment;
• Three lines of hormonal therapy are permitted prior to study entry (anti-androgen withdrawal is not considered as a second hormonal treatment);
• Serum testosterone level of \<50 ng/mL in patients without surgical castration;
• Patients must have serum potassium levels \>4.0 mEq/L and serum magnesium levels \>2.0 mg/dL.

You may not qualify if:

• Concomitant use of any anti-cancer therapy, except for continued use of luteinizing hormone-releasing hormone (LHRH) agonists or antiandrogens, or bisphosphonates or steroids initiated at least 4 weeks prior to study entry;
• Concomitant use of any investigational agent, including PC-SPES;
• Use of any investigational agent within 4 weeks of study entry;
• Concomitant use of warfarin (due to a potential drug-to-drug interaction with depsipeptide);
• Major surgery within 2 weeks of study entry;
• Prior treatment with chemotherapy;
• Patients with known cardiac abnormalities such as:
• Congenital long QT syndrome;
• QTc interval \> 480 milliseconds;
• Patients who have had a myocardial infarction within 12 months of study entry;
• Patients who have a history of coronary artery disease (CAD) e.g., angina Canadian Class II IV (see Appendix K). In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
• Patients with an ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥2 mm). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
• Patients with congestive heart failure that meets NYHA Class II to IV (see Appendix J) definitions and/or ejection fraction \<40% by MUGA scan or \<50% by echocardiogram and/or magnetic resonance imaging (MRI);
• Patients with a history of sustained VT, VF, Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD);
• Patients with hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction criteria above);

Sponsors & Collaborators

• Celgene: lead

Related Publications (5)

• Molife LR, Attard G, Fong PC, Karavasilis V, Reid AH, Patterson S, Riggs CE Jr, Higano C, Stadler WM, McCulloch W, Dearnaley D, Parker C, de Bono JS. Phase II, two-stage, single-arm trial of the histone deacetylase inhibitor (HDACi) romidepsin in metastatic castration-resistant prostate cancer (CRPC). Ann Oncol. 2010 Jan;21(1):109-13. doi: 10.1093/annonc/mdp270. Epub 2009 Jul 16.

  PMID: 19608618 BACKGROUND

• Rodon J, Perez-Fidalgo A, Krop IE, Burris H, Guerrero-Zotano A, Britten CD, Becerra C, Schellens J, Richards DA, Schuler M, Abu-Khalaf M, Johnson FM, Ranson M, Edenfield J, Silva AP, Hackl W, Quadt C, Demanse D, Duval V, Baselga J. Phase 1/1b dose escalation and expansion study of BEZ235, a dual PI3K/mTOR inhibitor, in patients with advanced solid tumors including patients with advanced breast cancer. Cancer Chemother Pharmacol. 2018 Aug;82(2):285-298. doi: 10.1007/s00280-018-3610-z. Epub 2018 Jun 7.

  PMID: 29882016 BACKGROUND

• Barata PC, Cooney M, Mendiratta P, Tyler A, Dreicer R, Garcia JA. Ketoconazole plus Lenalidomide in patients with Castration-Resistant Prostate Cancer (CRPC): results of an open-label phase II study. Invest New Drugs. 2018 Dec;36(6):1085-1092. doi: 10.1007/s10637-018-0660-3. Epub 2018 Sep 6.

  PMID: 30191523 BACKGROUND

• Komrokji RS, Al Ali NH, Padron E, Cogle C, Tinsley S, Sallman D, Lancet JE, Lis AF. Lenalidomide and Prednisone in Low and Intermediate-1 IPSS Risk, Non-Del(5q) Patients With Myelodysplastic Syndromes: Phase 2 Clinical Trial. Clin Lymphoma Myeloma Leuk. 2019 Apr;19(4):251-254. doi: 10.1016/j.clml.2018.12.014. Epub 2019 Jan 2.

  PMID: 30852241 BACKGROUND

• 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.

  PMID: 30624766 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

romidepsin; Depsipeptides

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2005
• First Posted: March 25, 2005
• Study Start: May 7, 2003
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: November 18, 2019

Record last verified: 2019-11