Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436579
Status:
TERMINATED
Last Update Posted:
2014-02-24
First Post:
2007-02-15
Brief Title:
Sorafenib in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Dose Escalation Study of Sorafenib BAY 43-9006 NSC 724772 in Nomotensive Patients With Advanced Malignancies
Status:
TERMINATED
Status Verified Date:
2011-10
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:
This randomized phase I trial is studying the side effects such as high blood pressure and best dose of sorafenib in treating patients with advanced solid tumors Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Determine whether increasing the dose of sorafenib tosylate increases the plasma steady-state concentration in patients with advanced solid tumors
II Determine whether increasing the dose of this drug affects blood pressure in these patients
SECONDARY OBJECTIVES
I Determine whether the variability in blood pressure elevation is due to pharmacokinetic or pharmacodynamic variability
II Compare the toxicity and differences in pharmacokinetics of delivering a higher dose of this drug per day using two different schedules vs delivering the currently recommended dose of this drug
III Investigate mechanisms of sorafenib tosylate-induced hypophosphatemia with serial measurements of phosphate metabolism no longer assessed as of 4292009 in these patients detailed baseline measurements in all patients and detailed evaluations of patients developing grade 3 or greater hypophosphatemia
IV Detect subclinical effects of this drug on measures of thyroid function V Identify biomarkers predicting the categorization of patient response
OUTLINE This is a randomized dose-escalation study
Patients receive oral sorafenib tosylate twice daily on days 1-7 and once on day 8 Patients not experiencing at least one grade 2 or higher toxicity during the initial sorafenib treatment are randomized to 1 of 3 dose-escalated treatment arms
ARM I Patients receive higher-dose oral sorafenib tosylate twice daily on days 15-36
ARM II Patients receive standard-dose oral sorafenib tosylate three times daily on days 15-36
ARM III closed to accrual as of 4292009 Patients receive standard-dose oral sorafenib tosylate twice daily on days 15-36
In all arms treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients undergo ambulatory blood pressure monitoring at baseline on days 7 14 and 21 and at 6 and 12 months Blood samples are collected periodically throughout study and evaluated for pharmacokinetic studies thyroid function serum markers and phosphate metabolism CT perfusion imaging is performed at baseline week 6 week 12 and then every 8-12 weeks thereafter
NOTE Phosphate metabolism no longer assessed as of 4292009
After completion of study treatment patients are followed every 4 weeks for 1 year and then every 3 months thereafter
I Determine whether increasing the dose of sorafenib tosylate increases the plasma steady-state concentration in patients with advanced solid tumors
II Determine whether increasing the dose of this drug affects blood pressure in these patients
SECONDARY OBJECTIVES
I Determine whether the variability in blood pressure elevation is due to pharmacokinetic or pharmacodynamic variability
II Compare the toxicity and differences in pharmacokinetics of delivering a higher dose of this drug per day using two different schedules vs delivering the currently recommended dose of this drug
III Investigate mechanisms of sorafenib tosylate-induced hypophosphatemia with serial measurements of phosphate metabolism no longer assessed as of 4292009 in these patients detailed baseline measurements in all patients and detailed evaluations of patients developing grade 3 or greater hypophosphatemia
IV Detect subclinical effects of this drug on measures of thyroid function V Identify biomarkers predicting the categorization of patient response
OUTLINE This is a randomized dose-escalation study
Patients receive oral sorafenib tosylate twice daily on days 1-7 and once on day 8 Patients not experiencing at least one grade 2 or higher toxicity during the initial sorafenib treatment are randomized to 1 of 3 dose-escalated treatment arms
ARM I Patients receive higher-dose oral sorafenib tosylate twice daily on days 15-36
ARM II Patients receive standard-dose oral sorafenib tosylate three times daily on days 15-36
ARM III closed to accrual as of 4292009 Patients receive standard-dose oral sorafenib tosylate twice daily on days 15-36
In all arms treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients undergo ambulatory blood pressure monitoring at baseline on days 7 14 and 21 and at 6 and 12 months Blood samples are collected periodically throughout study and evaluated for pharmacokinetic studies thyroid function serum markers and phosphate metabolism CT perfusion imaging is performed at baseline week 6 week 12 and then every 8-12 weeks thereafter
NOTE Phosphate metabolism no longer assessed as of 4292009
After completion of study treatment patients are followed every 4 weeks for 1 year and then every 3 months thereafter
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 |
|---|---|---|---|
| NCI-2009-00221 | REGISTRY | None | None |
| UCCRC-15002A | None | None | None |
| CDR0000528261 | None | None | None |
| 15002A | OTHER | None | None |
| 7768 | OTHER | None | None |
| U01CA069852 | NIH | None | None |
| P30CA014599 | NIH | CTEP | httpsreporternihgovquickSearchP30CA014599 |