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AzTrials

Prostate CancerPhase 2NCT00106418

A Research Study for Patients With Prostate Cancer

A Phase 2 study testing Romidepsin in people with Prostate Cancer and Metastases, run by Celgene.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer, Metastases
What is being tested?
Romidepsin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
7 May 2003to 1 Sep 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%;
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  • 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.

Who cannot join

  • 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;
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  • 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.

About this study

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

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.

Being tested
Romidepsin
Keywords
Prostate Cancer, Androgen independent metastatic prostate cancer patients with rising PSA, romidepsin
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RomidepsinDrug

    Also called Istodax, depsipeptide, FK 228

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

Study groups in NCT00106418
Study groupRoleWhat they receive
RomidepsinExperimental13 mg/m^2 of romidepsin intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle.
Receives: Drug: Romidepsin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2005 (estimated)
  2. Study start7 May 2003
  3. Primary completion1 Sep 2006
  4. Study completion1 Sep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00106418
Sponsor's protocol ID
FJ-228-0002
Status last verified
Nov 2019
First submitted
24 Mar 2005
Last updated
18 Nov 2019
Results posted
No

Publications

  • 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.

    PubMed 19608618

  • 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.

    PubMed 29882016

  • 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.

    PubMed 30191523

  • 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.

    PubMed 30852241

  • 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.

    PubMed 30624766

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Romidepsin in people with Prostate Cancer and Metastases, run by Celgene.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of objective disease control (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00106418, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.

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