NCT00072475

Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes

A Phase II Study of an Oral VEGF Receptor Tyrosine Kinase Inhibitor (PTK787/ZK222584) (IND #66370, NSC #719335) in Myelodysplastic Syndrome (MDS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 11/30/06. 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 2.5 years.

Conditions

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasms

Interventions

Type	Name	Description
DRUG	vatalanib	Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or \> tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)

Timeline

• Start date: 2003-12-01
• Primary completion: 2008-11-01
• Completion: 2014-06-01
• First posted: 2003-11-06
• Last updated: 2016-08-01
• Results posted: 2014-06-24

Locations

68 sites across 1 country: United States