Phase 1
Completed N=27
A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
Prostate Cancer · Hormone Refractory Prostate Cancer
Source: ClinicalTrials.gov NCT00510718 ↗
Enrolled (actual)
27
Serious AEs
29.1%
Results posted
Oct 2019
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) — 0; 6; 14; 8 Participants
Summary
This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) |
0; 6; 14; 8; 6; 1 | — |
| PRIMARY Percentage of Participants With at Least 1 Dose-limiting Toxicity (DLT): Multiple Dose Period |
0; 0; 0; 0; 1; 1 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of MDV3100: Multiple Dose Period |
240 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Single Dose Period |
5.43; 15.64; 38.21; 58.39; 79.26 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of MDV3100: Single Dose Period |
21.2; 53.1; 145.3; 208.5; 320.2; 363.4 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of MDV3100: Single Dose Period |
51.3; 92.7; 331.5; 459.2; 706.7; 952.7 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Single Dose Period |
1.98; 0.50; 0.53; 1.00; 1.03; 1.54 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of MDV3100: Single Dose Period |
0.43; 1.65; 3.30; 5.19; 6.68; 5.93 | — |
| SECONDARY Apparent Terminal Elimination Half-Life (T1/2) of MDV3100: Single Dose Period |
164.9; 100.5; 143.7; 138.9; 149.1; 144.0 | — |
| SECONDARY Apparent Volume of Distribution (V/F) of MDV3100: Single Dose Period |
131.7; 90.5; 91.89; 103.8; 108.2; 97.4 | — |
| SECONDARY Apparent Total Plasma Clearance (CL/F) of MDV3100: Single Dose Period |
0.585; 0.647; 0.453; 0.523; 0.509; 0.504 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Multiple Dose Period |
60.0; 109.8; 291.7; 395.7; 488.9; 463.1 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Multiple Dose Period |
2.07; 1.07; 1.00; 1.08; 1.57; 0.00 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of MDV3100: Multiple Dose Period |
2.76; 5.49; 14.07; 18.91; 24.57; 27.90 | — |
| SECONDARY Minimum Observed Plasma Concentration (Cmin) of MDV3100: Multiple Dose Period |
0.10; 0.00; 0.04; 0.00; 0.00; 0.00 | — |
| SECONDARY Apparent Total Plasma Clearance (CL/F) of MDV3100: Multiple Dose Period |
0.507; 0.580; 0.530; 0.628; 0.755; 1.037 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate;
- Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);
- Progressive disease after medical or surgical castration,
Exclusion Criteria
- Metastases in the brain or active epidural disease. (Note: patients with treated epidural disease are allowed);
Data sourced from ClinicalTrials.gov (NCT00510718). 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.