Back to resultsA Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients
Primary Purpose
Prostate Cancer, Prostate Neoplasms, Castration Resistant Prostate Cancer (CRPC)
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
MDV3100
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring docetaxel, Response Evaluation Criteria in Solid Tumor (RECIST), PSA level, MDV3100
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
dose-escalation cohort-1
dose-escalation cohort-2
dose-escalation cohort-3
dose-expansion cohort
Arm Description
MDV3100 low dose arm
MDV3100 middle dose arm
MDV3100 high dose arm
dose expansion with MDV3100 middle dose
Outcomes
Primary Outcome Measures
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.
Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
This measure will be assessed on the dose expansion cohort
Secondary Outcome Measures
Prostate Specific Antigen (PSA) Response
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.
Full Information
NCT ID
NCT01284920
First Posted
January 18, 2011
Last Updated
November 9, 2018
Sponsor
Astellas Pharma Inc
Collaborators
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01284920
Brief Title
A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients
Official Title
A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 2, 2010 (Actual)
Primary Completion Date
July 12, 2012 (Actual)
Study Completion Date
July 2, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Neoplasms, Castration Resistant Prostate Cancer (CRPC)
Keywords
docetaxel, Response Evaluation Criteria in Solid Tumor (RECIST), PSA level, MDV3100
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dose-escalation cohort-1
Arm Type
Experimental
Arm Description
MDV3100 low dose arm
Arm Title
dose-escalation cohort-2
Arm Type
Experimental
Arm Description
MDV3100 middle dose arm
Arm Title
dose-escalation cohort-3
Arm Type
Experimental
Arm Description
MDV3100 high dose arm
Arm Title
dose-expansion cohort
Arm Type
Experimental
Arm Description
dose expansion with MDV3100 middle dose
Intervention Type
Drug
Intervention Name(s)
MDV3100
Intervention Description
oral
Primary Outcome Measure Information:
Title
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead EGC
Description
This measure will be assessed on the dose escalation cohorts.
Time Frame
3 months during the study
Title
Tumor response assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Description
This measure will be assessed on the dose expansion cohort
Time Frame
Day 85 and end of long term dosing period
Secondary Outcome Measure Information:
Title
Prostate Specific Antigen (PSA) Response
Time Frame
Day 85 and end of long term dosing period
Title
Safety assessed by the vital signs, incidence of adverse events, labo-tests and 12-lead ECG
Description
This measure will be assessed on the dose expansion cohort.
Time Frame
3 months during the study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu
Country
Japan
City
Chugoku
Country
Japan
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kanto
Country
Japan
City
Kyusyu
Country
Japan
City
Shikoku
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Citations:
PubMed Identifier
26793974
Citation
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.
Results Reference
derived
Links:
URL
https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=110
Description
Link to results on the Astellas Clinical Study Results website
Learn more about this trial
A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients
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