Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 4:21 AM
Study NCT ID:
NCT01308034
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2011-03-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy
Sponsor:
Centre Leon Berard
Organization:
Study Overview
Official Title:
Phase I Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy
Status:
COMPLETED
Status Verified Date:
2022-01
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:
The purpose of this study is to determine the safety of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST (gastro intestinal stromal tumor) sarcomas who cannot be treated by surgery.
The primary objective of the study is to determine the maximum tolerated dose (MTD) of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST sarcomas who cannot be treated by surgery.
This study is a multicentre, open-label phase I with dose escalation : 2 dose levels.
3-6 patients will be included at each dose level.3-18 patients will be included in the study.
The primary objective of the study is to determine the maximum tolerated dose (MTD) of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST sarcomas who cannot be treated by surgery.
This study is a multicentre, open-label phase I with dose escalation : 2 dose levels.
3-6 patients will be included at each dose level.3-18 patients will be included in the study.
Detailed Description:
Study design : 2 dose levels
Step 1 : 25 mg once daily Step 2 : 37.5 mg once daily
3-6 patients will be included at each of the sunitinib dose levels, depending on the number of DLTs (dose limiting toxicity) occurring in 14 weeks after start of treatment
DLT is defined as :
any grade 3 or 4 musculoskeletal or cutaneous toxicity within the field of radiation any other toxicity \> or = 4
Secondary objectives are :
* to evaluate the safety with late toxicities
* to estimate the response rate at 6 months
* to estimate the progression free survival
* to evaluate the proportion of patients with an operable tumour after treatment
Exploratory objectives are :
* to study evolution during treatment of neo-angiogenesis measured by dynamic contrast enhanced-ultrasonography (DCE-US)
* to study the correlation between clinical response and changes of tumor perfusion measured by DCE-US
Step 1 : 25 mg once daily Step 2 : 37.5 mg once daily
3-6 patients will be included at each of the sunitinib dose levels, depending on the number of DLTs (dose limiting toxicity) occurring in 14 weeks after start of treatment
DLT is defined as :
any grade 3 or 4 musculoskeletal or cutaneous toxicity within the field of radiation any other toxicity \> or = 4
Secondary objectives are :
* to evaluate the safety with late toxicities
* to estimate the response rate at 6 months
* to estimate the progression free survival
* to evaluate the proportion of patients with an operable tumour after treatment
Exploratory objectives are :
* to study evolution during treatment of neo-angiogenesis measured by dynamic contrast enhanced-ultrasonography (DCE-US)
* to study the correlation between clinical response and changes of tumor perfusion measured by DCE-US
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-021551-11 | EUDRACT_NUMBER | None | View |