A Phase I Expanded Cohort Trial of Bortezomib and Sorafenib in Advanced Malignant Melanoma
- Since we are looking for the highest dose of the study drug that can be administered
safely without severe or unmanageable side effects in participants that have melanoma,
not everyone who participates will receive the same dose of the study drug. The dose
participants will get will depend upon the number of participants who have been
enrolled in the study before and how well they tolerated their doses.
- Each treatment cycle lasts 28 days. Participants will take sorafenib orally twice a
day and will receive bortezomib as an out-patient intravenous injection on Days 1, 8
and 15 of every cycle.
- At the end of each treatment cycle, participants will be examined to determine whether
their disease has worsened, improved or stayed the same, and to see if they are
experiencing any side effects of treatment. The following tests will be done at these
visits: physical examination, vital signs, blood tests and scans (repeated every 2
- Once the maximum tolerated dose of sorafenib and bortezomib have been determined, an
additional 12 participants will be enrolled in this study. This is called the
expansion cohort of this study. Participants enrolled in this cohort will be required
to undergo a biopsy of the tumor lesion before they start study treatment and an
additional biopsy after you start study treatment.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximally tolerated dose
To determine the maximally tolerated dose of weekly bortezomib in combination with 400mg twice daily sorafenib.
Ryan J. Sullivan, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|