EUCTR2013-002271-17-DE
Active, not recruiting
Phase 1
A Multi-center, Single Arm Study of Enzalutamide in Patients with Progressive Metastatic Castration-Resistant Prostate Cancer Previously Treated With Abiraterone Acetate
DrugsXtandi
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Astellas Pharma Europe B.V.
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject has histologically confirmed adenocarcinoma of the prostate
- •without neuro\-endocrine differentiation or small cell features.
- •2\. Subject has metastatic disease documented by bone scan or by soft
- •tissue disease observed by CT/MRI at screening, or within \=30 days
- •prior to Day 1\.
- •3\. Subject has a serum testosterone of \= 1\.7 nmol/L (or \= 50 ng/dL) at
- •4\. In the setting of castrate levels of testosterone \=1\.7 nmol/L (or \=50
- •ng/dL), subject has progressive disease at study entry defined as PSA
- •rise determined by a minimum of 2 rising PSA levels with an interval of \=
- •1 week between each assessment. The PSA value at the screening visit
Exclusion Criteria
- •1\. Subject has prior use of ketoconazole for the treatment of prostate cancer.
- •2\. Subject has prior use of cabazitaxel.
- •3\. Subject has prior use of enzalutamide.
- •4\. Subject has received ANY anti\-neoplastic therapy (including antiandrogens and chemotherapy) following abiraterone acetate discontinuation and prior to start of study drug at Day 1\.
- •5\. Subject has a known or suspected hypersensitivity to enzalutamide, or any components of the formulation used.
- •6\. Subject has known or suspected brain metastases or active leptomeningeal disease.
- •7\. Subject has history of seizure or any condition that may predispose to seizure (e.g., prior stroke or significant brain trauma).
- •8\. Subject has history of loss of consciousness or transient ischemic attack within 12 months of screening.
- •9\. Subject has concurrent disease or any clinically significant abnormality following the investigator’s review of the physical examination, electrocardiogram (ECG) and safety laboratory tests at screening, which in the judgment of the investigator would interfere with the subject's participation in this study or evaluation of study results.
- •10\. Subject has a history of another invasive cancer within 3 years prior to screening, with the exception of non\-melanoma skin cancers that have a remote probability of recurrence in the opinion of the Investigator in consultation with the medical monitor.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Enzalutamide Treatment of Metastatic Castration-Resistant Prostate Cancer Patients after Abiraterone AcetateMetastatic progressive castration-resistant prostate cancerMedDRA version: 16.1Level: PTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-002271-17-ESAstellas Pharma Europe B.V.200
Active, not recruiting
Phase 1
Enzalutamide Treatment of Metastatic Castration-Resistant Prostate Cancer Patients after Abiraterone AcetateMetastatic progressive castration-resistant prostate cancerMedDRA version: 19.0 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2013-002271-17-GBAstellas Pharma Europe B.V.215
Active, not recruiting
Phase 1
Enzalutamide Treatment of Metastatic Castration-Resistant Prostate Cancer Patients after Abiraterone AcetateEUCTR2013-002271-17-BEAstellas Pharma Europe B.V.200
Active, not recruiting
Phase 1
A study in patients with HER2-positive breast cancer that has spread and has not responded to one course of anti-cancer therapy.HER2-positive metastatic breast cancerMedDRA version: 14.1Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2012-001628-37-NOF. Hoffmann-La Roche Ltd2,003
Active, not recruiting
Phase 1
A study in patients with HER2-positive breast cancer that has spread and has not responded to one course of anti-cancer therapy.HER2 positive metastatic breast cancerMedDRA version: 15.0Level: LLTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2012-001628-37-ESF. Hoffmann-La Roche Ltd (representado en España por Roche Farma, S.A)1,000