Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072475
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2003-11-04
Brief Title:
Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of an Oral VEGF Receptor Tyrosine Kinase Inhibitor PTK787ZK222584 IND 66370 NSC 719335 in Myelodysplastic Syndrome MDS
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Vatalanib may be effective in preventing the development of leukemia in patients who have myelodysplastic syndromes
PURPOSE This phase II trial is studying vatalanib to see how well it works in treating patients with primary or secondary myelodysplastic syndromes
PURPOSE This phase II trial is studying vatalanib to see how well it works in treating patients with primary or secondary myelodysplastic syndromes
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in terms of hematologic improvement and complete and partial remission in patients with primary or secondary therapy-related myelodysplastic syndromes treated with vatalanib
Determine the time to transformation to acute myeloid leukemia at least 20 blasts or death in patients treated with this drug
Secondary
Determine the safety of this drug in these patients
Determine the duration of response in patients treated with this drug
Determine the cytogenetic response rate in patients treated with this drug
Determine the overall and progression-free survival of patients treated with this drug
Determine the incidence of infections requiring antibiotics or hospitalization or bleeding requiring red blood cell transfusions in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to risk group low grade refractory anemia with or without ringed sideroblasts refractory anemia with excess blasts-1 refractory cytopenia with multilineage dysplasia with or without ringed sideroblasts myelodysplastic syndromes-unclassified or chronic myelomonocytic leukemia-1 vs high grade refractory anemia with excess blasts-2 or chronic myelomonocytic leukemia-2
NOTE Stratification according to risk low vs high does not occur after 113006
Patients receive oral vatalanib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 6 additional courses after documentation of a CR
Patients are followed periodically for up to 5 years from study entry
PROJECTED ACCRUAL Approximately 144 patients will be accrued for this study within 25 years
Primary
Determine the response rate in terms of hematologic improvement and complete and partial remission in patients with primary or secondary therapy-related myelodysplastic syndromes treated with vatalanib
Determine the time to transformation to acute myeloid leukemia at least 20 blasts or death in patients treated with this drug
Secondary
Determine the safety of this drug in these patients
Determine the duration of response in patients treated with this drug
Determine the cytogenetic response rate in patients treated with this drug
Determine the overall and progression-free survival of patients treated with this drug
Determine the incidence of infections requiring antibiotics or hospitalization or bleeding requiring red blood cell transfusions in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to risk group low grade refractory anemia with or without ringed sideroblasts refractory anemia with excess blasts-1 refractory cytopenia with multilineage dysplasia with or without ringed sideroblasts myelodysplastic syndromes-unclassified or chronic myelomonocytic leukemia-1 vs high grade refractory anemia with excess blasts-2 or chronic myelomonocytic leukemia-2
NOTE Stratification according to risk low vs high does not occur after 113006
Patients receive oral vatalanib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 6 additional courses after documentation of a CR
Patients are followed periodically for up to 5 years from study entry
PROJECTED ACCRUAL Approximately 144 patients will be accrued for this study within 25 years
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 |
|---|---|---|---|
| CDR0000339810 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-10105 | None | None | None |