CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 155 enrolled
Drug / intervention
vatalanibdrug
Likely dose
750 mg/day orally (initial dose starting 1/15/05) or 1250 mg/day (for patients registered before 1/15/05), with potential escalation to 1000 mg/day and 1250 mg/day in 4-week intervals in absence of Grade 2 or greater toxicityAI-extracted
Key inclusion· 8
  • ✓Diagnosis of primary or secondary myelodysplastic syndrome (MDS) including RA, RAEB-1, RA with ringed sideroblasts, refractory cytopenia with multilineage dysplasia, MDS-unclassified, MDS with isolated del(5q), or CMML-1
  • ✓Age 18 years or older
  • ✓WHO performance status 0-2
  • ✓Bilirubin ≤1.5× ULN, AST ≤2.5× ULN, APTT ≤1.5× ULN, INR ≤1.5
Key exclusion· 8
  • ✕Prior leukemia (≥20% blasts)
  • ✕Prior primary or metastatic brain tumor or carcinomatous meningitis
  • ✕Prior low-dose antimetabolites for MDS (hydroxyurea, azacitidine, low-dose cytarabine)
  • ✕Prior cytotoxic therapy for MDS

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00072475
NCT00072475Phase 2Completed
CompareCT.gov

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

Alliance for Clinical Trials in Oncology·interventional·Posted Nov 6, 2003·Updated Aug 1, 2016

In Brief

A Phase 2 clinical trial evaluating vatalanib for Leukemia and 2 related conditions. Completed, enrolled 155 participants across 68 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2003
Enrollment StartDec 1, 2003
Primary CompletionNov 1, 2008
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 22.7 years ago

Interventions

vatalanibdrug

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)