Phase 1
Completed N=22
Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer
Source: ClinicalTrials.gov NCT01565928 ↗Enrolled (actual)
22
Serious AEs
34.9%
Results posted
Apr 2019
Primary outcomePrimary: Percentage of Participants Who Required Study Drug Dose Reduction During Treatment Periods 1 and 2 — 4.5; 0.0 percentage of participants
Summary
The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Required Study Drug Dose Reduction During Treatment Periods 1 and 2 |
4.5; 0.0 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) |
9.1 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs |
0; 1; 1; 0; 10; 7 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Electrocardiograms (ECG) |
1; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Docetaxel With and Without Enzalutamide Treatment |
1722.1; 1662.9 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Docetaxel With and Without Enzalutamide Treatment |
1866.6; 1674.4 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of Docetaxel With and Without Enzalutamide Treatment |
2020.1; 1769.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01565928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.