Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139360
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2005-08-30
Brief Title:
Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma
Sponsor:
Haukeland University Hospital
Organization:
Haukeland University Hospital
Study Overview
Official Title:
Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma and Predictive Value of Angiogenic Markers
Status:
COMPLETED
Status Verified Date:
2015-08
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:
None
Brief Summary:
To determine the efficacy as measured by objective tumor response of first-line treatment of metastatic melanoma with bevacizumab monotherapy
Detailed Description:
In Norway cutaneous malignant melanoma is the second most frequent and the most frequent cancer type in middle-aged 30-54 years females and males respectively and the incidence has six-doubled during the last 30 years Median survival for patients with metastatic melanoma is 6 months
Many agents have been investigated for anti-tumor effect in melanoma but there is no accepted standard therapy Biochemotherapy combining cytotoxic drugs with Interleukin-2 or Interferon alpha has not been shown to be superior to single agent Dacarbazine DTIC which is regarded to be the most active agent Other biological approaches like vaccination are currently under investigation but still no efficient treatment for metastatic melanoma is available DTIC induces objective remission in 20 of the patients but without significant impact on survival
The need of a new and effective treatment for the group of melanoma patients is urgently needed This will be the first study to assess response rates of bevacizumab monotherapy in first line treatment of metastatic melanoma In addition there will be a major focus on the identification of predictive biomarkers of bevacizumab efficacy
Many agents have been investigated for anti-tumor effect in melanoma but there is no accepted standard therapy Biochemotherapy combining cytotoxic drugs with Interleukin-2 or Interferon alpha has not been shown to be superior to single agent Dacarbazine DTIC which is regarded to be the most active agent Other biological approaches like vaccination are currently under investigation but still no efficient treatment for metastatic melanoma is available DTIC induces objective remission in 20 of the patients but without significant impact on survival
The need of a new and effective treatment for the group of melanoma patients is urgently needed This will be the first study to assess response rates of bevacizumab monotherapy in first line treatment of metastatic melanoma In addition there will be a major focus on the identification of predictive biomarkers of bevacizumab efficacy
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 94070013 | None | None | None |