A Phase 1a/1b Study to Evaluate the Safety of EZN-4176, in Adult Patients With Castration-Resistant Prostate Cancer

Paused · Phase 1

Conditions studied: Prostatic Neoplasm

In brief

This study will evaluate an experimental drug called EZN-4176 to determine the anticancer effects when it is given to patients with an advanced form of prostate cancer called castration-resistant prostate cancer (CRPC). Goals of this phase I study include finding out the dose of EZN-4176 that can be safely given without serious side effects and to determine the amount of EZN-4176 that should be given in future studies.

Key facts

Study ID

NCT01337518

Run by

Enzon Pharmaceuticals, Inc.

People needed

150

Starts

2011-03-01

Expected to finish

2013-12-01

Last updated by the study team

2012-12-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Capable of understanding protocol requirements \& risks \& providing written informed consent
• Histologically or cytologically confirmed diagnosis of metastatic prostate adenocarcinoma
• Ongoing gonadal androgen-deprivation therapy with LHRH analogs or orchiectomy. Patients without orchiectomy must receive effective LHRH analog therapy during the study
• Testosterone < 50 ng/dL
• Progressive disease after androgen deprivation - with all 3 of the following criteria:PSA evidence of progressive prostate cancer; PSA ≥ 5 ng/mL increasing on at least 2 successive occasions, at least 2 weeks apart. If confirmatory PSA < screening PSA, additional test for increasing PSA is needed
• Patients receiving anti-androgen agent as part of primary androgen ablation: disease progression after stopping the anti-androgen agent. This disease progression is defined: 2 consecutive increasing PSAs ≥ 2 weeks apart, or documented osseous or soft tissue progression. Flutamide patients: at least one of the PSAs ≥ 4 weeks after stopping flutamide. Bicalutamide or nilutamide patients: at least one PSA ≥ 6 weeks after stopping the anti-androgen agent.
• Patients who failed standard therapy or who, after physician discussion, wish to delay chemotherapy
• Age ≥ 18 yrs
• ECOG Score: 0-1
• Albumin ≥3.0 g/dL
• ANC ≥ 1,500/µL
• Plts ≥ 75,000/µL
• Hgb ≥ 9.0 g/dL
• Serum Creat. ≤ 1.5xULN or Calc Creat. clearance ≥ 60 mL/min
• Tot bili ≤ 1.5xULN
• AST; ALT: ≤ 2.5xULN

You may not qualify if…

• Prostate cancer other than adenocarcinoma, eg. neuroendocrine or small cell histology
• Concurrent serious medical illness that might interfere with protocol compliance
• Known chronic infectious disease, eg. AIDS or hepatitis
• Male patient of reproductive capacity unwilling to use methods appropriate to prevent pregnancy. In the UK, double-barrier contraception required. Patients should continue to use contraception for 3 months after stopping EZN-4176 due to potential for prolonged half-life of EZN-4176 in the liver.
• History of CNS tumor involvement
• Other hormonal therapy, eg. megestrol acetate (Megace®), finasteride (Proscar®), dutasteride (Avodart®), or any herbal product known to decrease PSA (e.g., saw palmetto, PC-SPES, and PC-HOPE)
• > 10 mg/day of prednisone or equivalent systemic corticosteroid within 4 weeks of first dose of EZN-4176
• Initiation of bisphosphonates within 4 weeks of enrollment. Patients receiving stable doses of bisphosphonates with subsequent tumor progression may continue to receive this medication; however, initiation of bisphosphonates is not allowed during the study.
• Therapy with supplements or complementary medicines/botanicals within 4 weeks of first dose of study drug, except for any combination of the following: Conventional multivitamin supplements; Selenium; Lycopene; and Soy supplements
• Prior chemotherapy, immunotherapy, investigational therapeutic agent, or other therapy used to treat the cancer within 4 weeks (6 weeks for prior treatment with mitomycin C or nitrosoureas) before first dose of EZN-4176
• Radiation or radioactive treatment within 4 weeks before first dose of EZN-4176. Single-fraction palliative radiation is allowed within 2 weeks before first dose of EZN-4176
• Lack of recovery from any reversible side effects (except alopecia and Grade 1 or 2 neuropathy) to Grade 0 or 1 toxicity related to administration of an investigational therapeutic agent, chemotherapy, immunotherapy, radiotherapy, or other agents previously used to treat the cancer
• Current participation in another clinical study with an investigational therapeutic agent and/or use of an investigational therapeutic drug (not including investigational use of an approved drug) in the 30 days before first dose of EZN-4176
• Inability to comply with study protocol
• Full anticoagulation therapy

Where it is running

• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Institute of Cancer Research, Royal Marsden Hospital — Sutton, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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