CI

At a glance

ClinicalIndex Comparison Record
Phase 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.

Search/NCT02296242
NCT02296242Phase 2Completed

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

BioMed Valley Discoveries, Inc·interventional·Posted Nov 20, 2014·Updated Jan 29, 2019

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
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