A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer
20 Years
N/A
Male
Prostate Neoplasms, Prostate Cancer, Castration Resistant Prostate Cancer (CRPC)
Trial Information
A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC
Outcome Description:
This measure will be assessed on the dose escalation cohorts.
Outcome Time Frame:
3 months during the study
Safety Issue:
No
Principal Investigator
Use Central Contact
Investigator Role:
Study Chair
Investigator Affiliation:
Astellas Pharma Inc
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
9785-CL-0111
NCT ID:
NCT01284920
Start Date:
November 2010
Completion Date:
December 2013
Related Keywords:
- Prostate Neoplasms
- Prostate Cancer
- Castration Resistant Prostate Cancer (CRPC)
- MDV3100
- Response Evaluation Criteria in Solid Tumor (RECIST)
- docetaxel
- PSA level
- Neoplasms
- Prostatic Neoplasms
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