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NCT01781429 · ClinicalTrials.gov registry record · Phase 1
Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies
A Phase 1 study of Advanced Solid Tumors, sponsored by BioMed Valley Discoveries.
- Completed
- Registry status
- Phase 1
- Development phase
- 136
- Enrollment target
- 9
- Study locations
NCT01781429: Completed Phase 1 study of Advanced Solid Tumors, sponsored by BioMed Valley Discoveries.
NCT01781429 is a Phase 1 study of Advanced Solid Tumors that has completed, run by BioMed Valley Discoveries. The registered enrollment target is 136 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (31% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01781429, a Phase 1 study of Advanced Solid Tumors, has completed, sponsored by BioMed Valley Discoveries.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 136 participants
- Enrollment target
- 9
- Study locations
Study 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.
Primary Outcome
DLT is defined as any BVD-523 related toxicity in the first 21 days of treatment that results in: 1. ≥Grade 4 hematologic toxicity for \>1 day; 2. Grade 3 hematologic toxicity with complications e.g., thrombocytopenia with bleeding; 3. ≥Grade 3 non-hematologic toxicity, except untreated nausea, vomiting, constipation, pain and rash (these become DLTs if the adverse event (AE) persists despite adequate treatment), a doubling of aspartate transaminase (AST)/alanine transaminase (ALT) in patients
Conditions Studied
Interventions
- DRUG BVD-523
Study Locations (9)
Tennessee
- Sarah Cannon Research Institute Hospital at Vanderbilt - Nashville
- Vanderbilt-Ingram Cancer Center - Nashville
California
- UCLA Med-Hematology & Oncology - Los Angeles
Connecticut
- Yale Cancer Center - New Haven
Florida
- Florida Cancer Specialists and Research Group (Sarah Cannon Research Institute) - Sarasota
Massachusetts
- Massachusetts General Hospital (MGH) - Boston
Missouri
- Washington University School of Medicine - St Louis
New York
- Memorial Sloan-Kettering Cancer Center - New York
Texas
- UT M.D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2013-03 |
| Est. Completion | 2018-09 |
| Phase | Phase 1 |
What the finished NCT01781429 record still lists
NCT01781429 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which BVD-523 is the first listed.
NCT01781429 lists 9 locations in 8 states (Tennessee, California, Connecticut).
Frequently Asked Questions
What is clinical trial NCT01781429 about?
NCT01781429 is a clinical study titled "Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies". 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...
What is the current status of trial NCT01781429?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2013-03. Estimated completion is 2018-09.
What conditions does trial NCT01781429 study?
This clinical trial studies the following conditions: Advanced Solid Tumors.
What interventions are being tested in trial NCT01781429?
The interventions under investigation include: BVD-523 (DRUG).
Who is sponsoring clinical trial NCT01781429?
This trial is sponsored by BioMed Valley Discoveries, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01781429 being conducted?
This trial has 9 study locations across California, Connecticut, Florida, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
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Where NCT01781429's enrollment target sits among peer trials
136 63rd of 144 higher than 82 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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