A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients

Astellas

Status and phase: Completed; Phase 2; Phase 1

Conditions: Castration Resistant Prostate Cancer (CRPC); Prostate Neoplasms; Prostate Cancer

Treatments: Drug: MDV3100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01284920

9785-CL-0111

Details and patient eligibility

About

This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.

Full 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.

Enrollment: 47 patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 4 patient groups

dose-escalation cohort-1

Experimental group

Description:

MDV3100 low dose arm

Treatment:

Drug: MDV3100

dose-escalation cohort-2

Experimental group

Description:

MDV3100 middle dose arm

Treatment:

Drug: MDV3100

dose-escalation cohort-3

Experimental group

Description:

MDV3100 high dose arm

Treatment:

Drug: MDV3100

dose-expansion cohort

Experimental group

Description:

dose expansion with MDV3100 middle dose

Treatment:

Drug: MDV3100