At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 53 enrolled
Drug / intervention
BVD-523drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1/2 Dose-Escalation, Safety, Clinical Activity, Pharmacokinetic and Pharmacodynamic Study of the ERK1/2 Inhibitor BVD-523 in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndromes
In Brief
A Phase 2 clinical trial evaluating BVD-523 for Acute Myelogenous Leukemia and Myelodysplastic Syndrome. Completed, enrolled 53 participants across 5 sites.
Detailed Summary
This study is being performed to assess the safety, tolerability, and preliminary clinical effects of BVD-523 given orally, twice daily for 21-day cycles, in patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedNov 2014
Primary CompletionJun 2017
TodayJul 2026
First PostedNov 20, 2014
Enrollment StartNov 1, 2014
Primary CompletionJun 15, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.6 years ago
Interventions
BVD-523drug
Oral, multiple escalating doses, twice daily, for 21 days in each treatment cycle