Enzalutamide Plus Everolimus in Men With Metastatic Castrate-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02125084|
Recruitment Status : Active, not recruiting
First Posted : April 29, 2014
Last Update Posted : April 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Everolimus Drug: Enzalutamide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enzalutamide Plus Everolimus in Men With Metastatic Castrate-Resistant Prostate Cancer: A Phase I Study With a Maximum Tolerated Dose Expansion Cohort|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: Everolimus and Enzalutamide
Dose Escalation Phase (18 patients): 3-6 patients will be treated at each dose level until the Maximum Tolerated Dose (MTD) is determined.
Dose Expansion Phase (23 patients): Everolimus and Enzalutamide to be administered using the MTD determined in the dose escalation phase.
Other Name: MDV3100
- Maximum Tolerated Dose (MTD) of everolimus plus enzalutamide. [ Time Frame: 6-8 months ]MTD will be determined by testing increasing doses of everolimus with standard dose enzalutamide in 3-patient dose escalation cohorts. The MTD is defined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during 1 cycle (28 days) of therapy, assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
- Prostate-specific antigen (PSA) response rate [ Time Frame: every 8 weeks for up to 24 months ]PSA response will be measured by the percent decreased from the reported baseline value. The proportion of patients with documented PSA decreases of 50% and 85% in PSA levels will be reported separately.
- Number of patients with serious and non-serious adverse events. [ Time Frame: every 4 weeks up to 24 months ]Evaluate the safety of the combination per CTCAE v4.0, every 4 weeks from date of first study treatment until the date of documented progression, up to 24 months.
- Pharmacokinetic sampling for everolimus [ Time Frame: Cycle 1, Day 1: prior to initial dose and 2hrs post-dose; Cycles 2 and 3, Day 1: prior to initial dose ]Levels of everolimus in blood samples will be collected from patients at selected timepoints prior to dosing during the first 3 cycles of treatment.
- Time to PSA progression [ Time Frame: every 8 weeks up to 24 months ]Defined as the time from date of first protocol treatment until date of PSA progression. PSA progression is defined as when patient has both a ≥25% increase above the nadir or baseline value and when the absolute increase is ≥2ng/mL.
- Overall Response Rate (ORR) [ Time Frame: every 8 weeks up to 24 months ]Soft tissue response rate [percentage of complete responders (CR) and partial responders (PR) per RECIST v1.1]
- Progression-free survival (PFS) [ Time Frame: every 8 weeks up to 24 months ]Restaging will occur every 8 weeks from date of first treatment until date of first progression, or date of death from any cause, whichever comes first - up to 24 months.
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): NCT02125084
|United States, Florida|
|Florida Cancer Specialists|
|Fort Myers, Florida, United States, 33916|
|Florida Cancer Center|
|Saint Petersburg, Florida, United States, 33705|
|United States, Ohio|
|Oncology Hematology Care Inc.|
|Cincinnati, Ohio, United States, 45242|
|United States, Tennessee|
|Chattanooga, Tennessee, United States, 37404|
|Tennessee Oncology PLLC|
|Nashville, Tennessee, United States, 37203|
|Study Chair:||John D. Hainsworth, MD||SCRI Development Innovations, LLC|