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Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

Primary Purpose

Metastatic Castration-Resistant Prostate Cancer

Status

Approved for marketing

Phase

Locations

Study Type

Expanded Access

Intervention

MDV3100

About this trial

This is an expanded access trial for Metastatic Castration-Resistant Prostate Cancer focused on measuring prostate, MDV3100, cancer

Eligibility Criteria

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Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate
Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) or orchiectomy
At least one prior chemotherapy regimen for metastatic castration-resistant prostate cancer with at least one regimen containing docetaxel
Progressive disease as evidenced by prostate specific antigen (PSA) rise or radiographic or clinical worsening of disease
No known or suspected brain metastasis
There is no comparable or satisfactory alternative therapy to treat the subject's disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

History of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or alcoholism
History of loss of consciousness or transient ischemic attack within the last 12 months
Clinically significant cardiovascular disease
Following lab values:
- Absolute neutrophil count is <1,000/µL
- Platelet count is <50,000/µL
- Hemoglobin is < 5.6 mmol/L (9 g/dL)
- Total bilirubin ≥1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥2.5 x ULN
- Creatinine clearance is less than 30 ml/min by the Cockcroft and Gault formula
Subject's conditions suggests that a bone fracture or complication of a bone fracture (such as compression of the spinal cord or other nerves) is likely to occur very soon
Subject has participated in a previous clinical study of MDV3100 for which the primary endpoint has not yet been reported (e.g., the PREVAIL trial)

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01606982

First Posted

May 24, 2012

Last Updated

February 15, 2017

Sponsor

Astellas Pharma Global Development, Inc.

Collaborators

Medivation, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01606982

Brief Title

Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

Official Title

A Multicenter, Single-arm, Open Label Treatment Protocol to Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

Study Type

Expanded Access

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Approved for marketing

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Global Development, Inc.

Collaborators

Medivation, Inc.

4. Oversight

5. Study Description

Brief Summary

The purpose of this treatment protocol is to provide expanded access to MDV3100 and monitor its safety in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.

Detailed Description

THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) AND HEALTH CANADA HAVE APPROVED MDV3100 (ENZALUTAMIDE) FOR SALE TO THE PUBLIC, ENROLLMENT IS CLOSED IN BOTH THE UNITED STATES AND CANADA. The expanded access treatment protocol is being conducted while marketing approval of enzalutamide is being sought. There is no age requirement. Subjects will complete visits on Day 1, Week 4, Week 12 and then every subsequent 12 weeks until discontinued from the study. The study will end if enzalutamide is approved for sale to the public by the country's health authority (commercially available) or if the sponsor otherwise decides or is required to end the study. If a subject would like to receive enzalutamide after the study ends, he and the doctor will decide if he should receive a prescription for enzalutamide, with a goal of avoiding any interruption in treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Castration-Resistant Prostate Cancer

Keywords

prostate, MDV3100, cancer

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

MDV3100

Other Intervention Name(s)

Xtandi, enzalutamide (USAN)

Intervention Description

oral

10. Eligibility

Sex

Male

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) or orchiectomy At least one prior chemotherapy regimen for metastatic castration-resistant prostate cancer with at least one regimen containing docetaxel Progressive disease as evidenced by prostate specific antigen (PSA) rise or radiographic or clinical worsening of disease No known or suspected brain metastasis There is no comparable or satisfactory alternative therapy to treat the subject's disease Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion Criteria: History of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or alcoholism History of loss of consciousness or transient ischemic attack within the last 12 months Clinically significant cardiovascular disease Following lab values: Absolute neutrophil count is <1,000/µL Platelet count is <50,000/µL Hemoglobin is < 5.6 mmol/L (9 g/dL) Total bilirubin ≥1.5 x upper limit of normal (ULN) Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥2.5 x ULN Creatinine clearance is less than 30 ml/min by the Cockcroft and Gault formula Subject's conditions suggests that a bone fracture or complication of a bone fracture (such as compression of the spinal cord or other nerves) is likely to occur very soon Subject has participated in a previous clinical study of MDV3100 for which the primary endpoint has not yet been reported (e.g., the PREVAIL trial)

12. IPD Sharing Statement

Citations:

PubMed Identifier

25683285

Citation

Joshua AM, Shore ND, Saad F, Chi KN, Olsson CA, Emmenegger U, Scholz M, Berry W, Mukherjee SD, Winquist E, Haas NB, Foley MA, Dmuchowski C, Perabo F, Hirmand M, Hasabou N, Rathkopf D; Enzalutamide Expanded Access Study Investigators. Safety of enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel: expanded access in North America. Prostate. 2015 Jun;75(8):836-44. doi: 10.1002/pros.22965. Epub 2015 Feb 14.

Results Reference

derived

Links:

URL

https://www.astellasclinicalstudyresults.com/study.aspx?ID=23

Description

Link to results on Astellas Clinical Study Results website

Learn more about this trial

Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

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