Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
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
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expanded_access
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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.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2012
CompletedFirst Posted
Study publicly available on registry
May 28, 2012
CompletedFebruary 17, 2017
February 1, 2017
May 24, 2012
February 15, 2017
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Global Development, Inc.lead
- Medivation, Inc.collaborator
Related Publications (1)
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.
PMID: 25683285DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2012
First Posted
May 28, 2012
Last Updated
February 17, 2017
Record last verified: 2017-02