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A Research Study for Patients With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00106418
Recruitment Status : Completed
First Posted : March 25, 2005
Last Update Posted : November 18, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastases Drug: Romidepsin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Phase II, Multicenter, Open-label Trial Evaluating the Activity and Tolerability of FK228 in Androgen Independent Metastatic Prostate Cancer Patients With Rising PSA
Actual Study Start Date : May 7, 2003
Actual Primary Completion Date : September 1, 2006
Actual Study Completion Date : September 1, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Romidepsin

Arm Intervention/treatment
Experimental: Romidepsin
13 mg/m^2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
Drug: Romidepsin
13 mg/m2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
Other Names:
  • Istodax
  • depsipeptide
  • FK 228

Primary Outcome Measures :
  1. Rate of objective disease control [ Time Frame: Up to 6 months ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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);
  • Patients with uncontrolled hypertension i.e., ≥160/95;
  • Patients with any cardiac arrhythmia requiring anti-arrhythmic medication;
  • Concomitant use of medications which may cause a prolongation of QT/QTc (see Appendix D) interval;
  • Concomitant use of medications that are inhibitors of the cytochrome P-450 isoenzyme CYP 3A4 (see Appendix E);
  • Clinically significant active infection;
  • Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
  • Previous extensive radiotherapy involving 30% of bone marrow (e.g., whole of pelvis, half of spine);
  • Clinical or radiological imaging evidence of brain metastasis (computed tomography [CT] or MRI scans are required only if brain metastasis is suspected clinically);
  • Inadequate bone marrow or other organ function, as evidenced by:

    • hemoglobin <9.0 g/dL (transfusions and/or erythropoietin are permitted);
    • absolute neutrophil count (ANC) ≤1.5 x 109 cells/L;
    • platelet count <100 x 109 cells/L;
    • total bilirubin >1.25 x upper limit of normal (ULN) for institution or >2.0 x ULN in the presence of demonstrable liver metastases;
    • aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >2.0 x ULN or >5.0 x ULN in the presence of demonstrable liver metastases;
    • serum creatinine >2 mg/dL;
  • Serum potassium levels < 4.0 mEq/L and serum magnesium levels <2.0 mg/dL;
  • Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively); or
  • Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.


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Responsible Party: Celgene Identifier: NCT00106418    
Obsolete Identifiers: NCT00058643
Other Study ID Numbers: FJ-228-0002
First Posted: March 25, 2005    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Keywords provided by Celgene:
Prostate Cancer
Androgen independent metastatic prostate cancer patients with rising PSA
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents