Clinical trial · Interventional
A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients
A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer
NCT01284920CI-TRIAL-00082817completedPhase 1 / Phase 2ClinicalTrials.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)
This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration Resistant Prostate Cancer (CRPC) | Castration-Resistant Prostate Carcinoma | ALIAS | 0.85 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Neoplasms | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDV3100 | Drug | Enzalutamide | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- dose-escalation cohort-1
- description
- MDV3100 low dose arm
- interventionNames
- Drug: MDV3100
- type
- EXPERIMENTAL
- label
- dose-escalation cohort-2
- description
- MDV3100 middle dose arm
- interventionNames
- Drug: MDV3100
- type
- EXPERIMENTAL
- label
- dose-escalation cohort-3
- description
- MDV3100 high dose arm
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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 Cohort, the patient has no more than two prior chemotherapy regimens with at least one regimen containing docetaxel * For Expansion Cohort, the patient must have measurable lesions by RECIST Exclusion Criteria: * Metastases in the brain * History of another malignancy except for adenocarcinoma of the prostate within the previous 5 years * Use of bicalutamide within 6 weeks prior to study * Radiation therapy within 12 weeks prior to study * Evidence of serious drug hypersensitivity
References
Publications (1)
- DERIVEDAkaza H, Uemura H, Tsukamoto T, Ozono S, Ogawa O, Sakai H, Oya M, Namiki M, Fukasawa S, Yamaguchi A, Uemura H, Ohashi Y, Maeda H, Saito A, Takeda K, Naito S. A multicenter phase I/II study of enzalutamide in Japanese patients with castration-resistant prostate cancer. Int J Clin Oncol. 2016 Aug;21(4):773-782. doi: 10.1007/s10147-016-0952-6. Epub 2016 Jan 21. PMID 26793974