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NCT02279433 · ClinicalTrials.gov registry record · Phase 1

A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b

A Phase 1 study of Solid Tumors, sponsored by Nuvation Bio.

Completed
Registry status
Phase 1
Development phase
46
Enrollment target
6
Study locations

NCT02279433 is a Phase 1 study of Solid Tumors that has completed, run by Nuvation Bio. The registered enrollment target is 46 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (84% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT02279433, a Phase 1 study of Solid Tumors, has completed, sponsored by Nuvation Bio.

COMPLETED
Registry status
Phase 1
Development phase
46 participants
Enrollment target
6
Study locations

Study Summary

DS-6051b is an orally administered inhibitor of the tyrosine kinases (ROS1) and neurotropic tyrosine kinase receptors (NTRK). This phase 1 first-in-human study evaluates safety and tolerability of DS-6051b in cancer subjects and identify a recommended phase 2 dose (RP2D). In addition, this study will also assess the pharmacokinetic (PK)/pharmacodynamic (PD) profiles and preliminary efficacy of DS-6051b.

Conditions Studied

Interventions

  • DRUG DS6051b

Study Locations (6)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana Farber Cancer Inst. - Boston

Arizona

  • HonorHealth Research Institute - Scottsdale

California

  • Chao Family Comprehensive Cancer Center of - Orange

New York

  • New York University - New York

Texas

  • South Texas Accelerated Research Therapeutics - San Antonio

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2014-09
Est. Completion 2019-03
Phase Phase 1

Sponsor

Nuvation Bio

7 total trials

What the Registry Record Tells You About NCT02279433

The ClinicalTrials.gov registry entry for NCT02279433 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (84% lower). The listed sponsor is Nuvation Bio, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which DS6051b is the first listed.

NCT02279433 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Massachusetts, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT02279433 about?

NCT02279433 is a clinical study titled "A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b". DS-6051b is an orally administered inhibitor of the tyrosine kinases (ROS1) and neurotropic tyrosine kinase receptors (NTRK). This phase 1 first-in-human study evaluates safety and tolerability of DS-6051b in cancer subjects and identify a recommended phase 2 dose (RP2D). In addition, this study wil...

What is the current status of trial NCT02279433?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2014-09. Estimated completion is 2019-03.

What conditions does trial NCT02279433 study?

This clinical trial studies the following conditions: Solid Tumors.

What interventions are being tested in trial NCT02279433?

The interventions under investigation include: DS6051b (DRUG).

Who is sponsoring clinical trial NCT02279433?

This trial is sponsored by Nuvation Bio, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02279433 being conducted?

This trial has 6 study locations across Arizona, California, Massachusetts, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.