A Phase 1a/1b Study to Evaluate the Safety of EZN-4176, in Adult Patients With Castration-Resistant Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01337518|
Recruitment Status : Suspended (Reassessment of strategic direction)
First Posted : April 19, 2011
Last Update Posted : December 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasm||Drug: EZN-4176||Phase 1|
This study will be conducted in two phases:
- Phase 1a will involve dose escalation to determine the maximum tolerated dose (MTD). The MTD will be determined on the basis of the results from the safety evaluation.
- Phase 1b will involve cohort expansion at one or more dose levels to determine the recommended Phase 2 dose. The recommended Phase 2 dose, which may differ from the MTD, will be determined on the basis of results from safety, activity, and pharmacologic and correlative studies.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1a/1b, Open-Label Study Evaluating the Safety and Tolerability of EZN-4176, an Androgen Receptor mRNA Antagonist, in Adult Patients With Castration-Resistant Prostate Cancer|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
EZN-4176 can be administered as a weekly one-hour i.v. infusion; weekly for 3 weeks followed by a 1 week rest; or 1 out of 2 weeks (every other week)
Other Name: Androgen Receptor mRNA Antagonist
- Determine the Maximum Tolerated Dose (MTD) of EZN-4176 administered as a weekly 1-hour IV infusion. [ Time Frame: 2012 ]Evaluate incidence, severity and duration of adverse events using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0, during first cycle.
- Determine the recommended Phase 2 dose of EZN-4176 [ Time Frame: 2013 ]Incidence, severity and duration of adverse events using National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0, during all cycles; Objective response, as assessed per recommendations of the Prostate Cancer Clinical Trials Working Group (PCWG2).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01337518
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Institute of Cancer Research, Royal Marsden Hospital|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Study Director:||Aby Buchbinder, MD||Enzon Pharmaceuticals, Inc.|
|Principal Investigator:||Daniel Danila, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Johann de Bono, MD||Institute of Cancer Research, Royal Marsden Hospital|