Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-26 @ 12:28 AM
Study NCT ID:
NCT01551459
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2012-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
Sponsor:
The Clatterbridge Cancer Centre NHS Foundation Trust
Organization:
Study Overview
Official Title:
A Randomised Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUAVE
Brief Summary:
Doctors usually treat uveal melanoma with radiotherapy or surgery. But if this cancer spreads, it is more difficult to treat.
Doctors usually treat uveal melanoma that has spread with a chemotherapy called dacarbazine, but they are always looking to find new ways to treat uveal melanoma.
This study aims to find out how well Sunitinib works to treat uveal melanoma and to see how long Sunitinib and Dacarbazine can help to prevent the cancer from getting worse.
Doctors usually treat uveal melanoma that has spread with a chemotherapy called dacarbazine, but they are always looking to find new ways to treat uveal melanoma.
This study aims to find out how well Sunitinib works to treat uveal melanoma and to see how long Sunitinib and Dacarbazine can help to prevent the cancer from getting worse.
Detailed Description:
124 eligible patients will be randomised to either Sunitinib or Dacarbazine treatment. Participants will then attend 3-weekly clinic visits and undergo 12-weekly tumour assessment (CT or MRI scan) until disease progression (according to RECIST 1.1) has been identified.
At progression, patients may crossover to the other study treatment and continue with 3-weekly clinic visits and 12-weekly imaging until second progression.
At progression, patients may crossover to the other study treatment and continue with 3-weekly clinic visits and 12-weekly imaging until second progression.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: