Clinical trial
Trametinib in treating patients with progressive metastatic hormone-resistant prostate cancer
This phase II trial studies how well trametinib works in treating patients with hormone-resistant prostate cancer that is growing or getting worse and has spread to other parts of the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label, Two-Stage Phase II Study of the MEK 1/2 Inhibitor Trametinib in Men With Progressive Metastatic Castrate Resistant Prostate Cancer
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment (trametinib)
Patients receive trametinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Drug: Trametinib
Given PO
Other Names:
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| Category | Value |
|---|---|
| Date last updated at source | 2016-08-25 |
| Study type(s) | Randomised clinical trial |
| Expected enrolment | 62 |
| Study start date | 2016-09-01 |
| Estimated primary completion date | 2019-09-01 |