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COMPLETED Phase 1

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

NCT01781429 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 136 participants
Start Date 2013-03
Est. Completion 2018-09
Phase Phase 1

Sponsor

BioMed Valley Discoveries

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01781429

The ClinicalTrials.gov registry entry for NCT01781429 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioMed Valley Discoveries, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01781429 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Tennessee, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01781429?

The interventions under investigation include: BVD-523 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01781429?

This trial is sponsored by BioMed Valley Discoveries, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial