Castration Resistant Prostate Cancer (CRPC), Prostate Cancer, Prostate Neoplasms
Conditions
Keywords
docetaxel, Response Evaluation Criteria in Solid Tumor (RECIST), PSA level, MDV3100
Brief summary
This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.
Detailed description
This is a Phase1/2, open-label, uncontrolled study, involving Dose-Escalation Cohorts, where dose will be escalated to next dose with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients and an Expansion Cohort, where the efficacy, safety, and PK of MDV3100 in post-chemo mCRPC patients will be evaluated. After evaluation of the safety and tolerability in Dose-Escalation Cohorts, additional patients are included in Expansion Cohort.
Interventions
DRUGMDV3100
oral
Sponsors
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC | 3 months during the study | This measure will be assessed on the dose escalation cohorts. |
| Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) | Day 85 and end of long term dosing period | This measure will be assessed on the dose expansion cohort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Specific Antigen (PSA) Response | Day 85 and end of long term dosing period | — |
| Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG | 3 months during the study | This measure will be assessed on the dose expansion cohort. |
Countries
Japan
Outcome results
None listed