Clinical trial · Interventional
Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer
A PHASE 1B, OPEN-LABEL, SAFETY AND TOLERABILITY STUDY OF ORAL MDV3100 IN COMBINATION WITH DOCETAXEL IN MEN WITH ADVANCED PROSTATE CANCER
NCT01565928CI-TRIAL-00038267completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDV3100 | Drug | Enzalutamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MDV3100
- interventionNames
- Drug: MDV3100
Primary outcomes (2)
- measure
- Percentage of Participants Who Required Study Drug Dose Reduction During Treatment Periods 1 and 2
- timeFrame
- Treatment Period 1 (Day 1) up to end of Treatment Period 2 (42 days)
- description
- 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.
- measure
- Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
- timeFrame
- Treatment Period 1 (Day 1) up to end of study treatment (maximum 70 months)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Willing and able to provide informed consent; * Men, 18 years of age or older; * Histologically or cytologically confirmed adenocarcinoma of the prostate; * Ongoing androgen deprivation therapy Exclusion Criteria: * Severe concurrent disease; * Known or suspected brain metastasis; * History of another malignancy within the previous 5 years; * Prior treatment with docetaxel-based chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.