An Expanded Cohort Trial of Bortezomib and Sorafenib in Advanced Malignant Melanoma
|ClinicalTrials.gov Identifier: NCT01078961|
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : June 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: bortezomib Drug: sorafenib||Phase 1|
- 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 months).
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Expanded Cohort Trial of Bortezomib and Sorafenib in Advanced Malignant Melanoma|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||June 2016|
|Experimental: Dose Escalation||
Given intravenously on days 1, 8 and 15 of each 28 day cycle
400mg taken orally twice a day
- Maximally tolerated dose [ Time Frame: 2 years ]To determine the maximally tolerated dose of weekly bortezomib in combination with 400mg twice daily sorafenib.
- Document and summarize toxicities [ Time Frame: 2 years ]To document and summarize the toxicities of weekly bortezomib in combination with 400mg twice daily sorafenib
- Anti-tumor activity [ Time Frame: 2 years ]To document the anti-tumor activity of weekly bortezomib in combination with sorafenib by describing the six-month progression free survival, one-year progression-free survival, and objective response rate.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078961
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Ryan J. Sullivan, MD||Massachusetts General Hospital|