CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 136 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/NCT01781429
NCT01781429Phase 2Completed

Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies

BioMed Valley Discoveries, Inc·interventional·Posted Feb 1, 2013·Updated Mar 20, 2020

In Brief

A Phase 2 clinical trial evaluating BVD-523 for Advanced Solid Tumors. Completed, enrolled 136 participants across 9 sites.

Detailed Summary

This open-label, multi-center Phase 1/2 study will assess the safety, pharmacokinetics, and pharmacodynamics of escalating doses of BVD-523 in patients with advanced malignancies. The study also seeks to demonstrate target modulation and early signs of clinical response in select patient populations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2013
Enrollment StartMar 1, 2013
Primary CompletionFeb 1, 2018
Study CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 13.4 years ago

Interventions

BVD-523drug

Oral, multiple escalating doses, twice daily, for 21 days in each treatment cycle