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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Prostate Neoplasms; Castration Resistant Prostate Cancer (CRPC)
• Intervention / Treatment: Drug: MDV3100

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Chubu, Japan
  • Chugoku, Japan
  • Hokkaido, Japan
  • Kansai, Japan
  • Kanto, Japan
  • Kyusyu, Japan
  • Shikoku, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dose-escalation cohort-1; MDV3100 low dose arm	Drug: MDV3100; oral
Experimental: dose-escalation cohort-2; MDV3100 middle dose arm	Drug: MDV3100; oral
Experimental: dose-escalation cohort-3; MDV3100 high dose arm	Drug: MDV3100; oral
Experimental: dose-expansion cohort; dose expansion with MDV3100 middle dose	Drug: MDV3100; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC	This measure will be assessed on the dose escalation cohorts.	3 months during the study
Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST)	This measure will be assessed on the dose expansion cohort	Day 85 and end of long term dosing period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	This measure will be assessed on the dose expansion cohort.	3 months during the study

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
• Investigators: Study Chair: Use Central Contact, Astellas Pharma Inc

Publications and helpful links

General Publications

• Akaza 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.

Helpful Links

• Link to results on the Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2010
• Primary Completion (Actual): July 12, 2012
• Study Completion (Actual): July 2, 2014

Study Registration Dates

• First Submitted: January 18, 2011
• First Submitted That Met QC Criteria: January 26, 2011
• First Posted (Estimated): January 27, 2011

Study Record Updates

• Last Update Posted (Actual): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: MDV3100; docetaxel; Response Evaluation Criteria in Solid Tumor (RECIST); PSA level
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 9785-CL-0111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.