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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|