EUCTR2010-022239-12-HU
Active, not recruiting
Not Applicable
A Phase 1b/2 Study of Docetaxel and Prednisone, with or without ISIS 183750 (an eIF4E Inhibitor), inPatients with Castrate-Resistant Prostate Cancer - N/A
Isis Pharmaceuticals, Inc.0 sites112 target enrollmentMay 31, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Isis Pharmaceuticals, Inc.
- Enrollment
- 112
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with castrate\-resistant prostate cancer are eligible to be included in the study only if they meet all of the
- •following criteria:
- •1\. Provide written informed consent prior to Screening.
- •2\. Age \= 18 years.
- •3\. Histological or cytological diagnosis of adenocarcinoma of the prostate.
- •4\. Metastatic disease for which no curative therapy exists and for which systemic
- •chemotherapy is indicated.
- •5\. Progression of disease despite either medical or surgical castration. If the patient
- •received medical androgen ablation, a castrate level of testosterone (\= 50 ng/dL)
- •must have been present concurrent with disease progression. Progressive disease is
Exclusion Criteria
- •Patients will be excluded from the study if they meet any of the following criteria:
- •1\. Treatment with another investigational drug or device within 4 weeks or biological
- •agent within 6 weeks before Screening or 5 half\-lives of study agent, whichever is
- •2\. Pre\-existing peripheral neuropathy \= Common Terminology Criteria for Adverse
- •Events, Version 4\.0 (CTCAE) Grade 2\.
- •3\. Patients with treated or untreated parenchymal brain metastases or leptomeningeal disease. Currently active
- •malignant epidural disease is also excluded. Previously treated epidural disease does not exclude the patient from
- •the study. (Note: CT or MRI of brain is not needed to rule these out unless the patient has clinical symptoms
- •suggestive of CNS metastases).
- •4\. Have active infection or serious concomitant systemic disorder (for example, heart
Outcomes
Primary Outcomes
Not specified
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