| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01284920 | A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients | PHASE1 | COMPLETED | 47 | — | — | Nov 2, 2010 | Jul 2, 2014 | Nov 21, 2024 | 7 | Japan |
| NCT01565928 | Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer | PHASE1 | COMPLETED | 23 | — | — | Jan 24, 2012 | Feb 26, 2018 | Apr 22, 2019 | 3 | United States |
| NCT00510718 | A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer | PHASE1 | COMPLETED | 140 | — | — | Jul 23, 2007 | Apr 2, 2018 | Oct 3, 2019 | 9 | United States |
This measure will be assessed on the dose escalation cohorts.
This measure will be assessed on the dose expansion cohort
Percentage of participants that required dose reductions of Docetaxel and Enzalutamide treatment were reported in this outcome measure. Dose modifications (interruptions or dose reductions) were permitted for participants who had adverse events that were intolerable or could not be improved by other means. Dose reductions or delays were determined according to the prescribing information and at the discretion of the investigator.
AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Percentage of participants that discontinued study drug due to adverse events were reported in this outcome measure.
An adverse events (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both SAEs and non-SAEs.
DLT was defined as a national cancer institute's common toxicity criteria for adverse events (NCI-CTCAE) version 3.0 grade 3 or greater toxicity regardless of perceived causality that is not improved by the use of adequate/maximal medical intervention. Grade 3 alopecia, fever without neutropenia, nausea, vomiting, fatigue, and self-limited or medically controllable adverse events were not considered as DLTs.
Tolerability was defined as if less than (\<) 4/12 in participants with no prior exposure to MDV3100 (chemo-naive) and \< 4/12 prior chemotherapy participants experienced a DLT within the first 35 days of the multiple dose period. For doses higher than 360 mg/day, tolerability was defined if \<8/24 participants previously treated with chemotherapy experience a DLT within the first 35 days of the multiple dose period. MTD was defined as a dose below the intolerable dose.
| Arm | Type | Description |
|---|---|---|
| dose-escalation cohort-1 | EXPERIMENTAL | MDV3100 low dose arm |
| dose-escalation cohort-2 | EXPERIMENTAL | MDV3100 middle dose arm |
| dose-escalation cohort-3 | EXPERIMENTAL | MDV3100 high dose arm |
| dose-expansion cohort | EXPERIMENTAL | dose expansion with MDV3100 middle dose |
| MDV3100 | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | MDV3100 |
| Name | Type | Description |
|---|---|---|
| MDV3100 | DRUG | oral |
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Ongoing androgen deprivation therapy with a GnRH analogue or a bilateral orchiectomy * Progressive disease after prior androgen deprivation therapy (medical or surgical castration) * For Expansion Cohor...