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NCT01149720 · ClinicalTrials.gov registry record · Phase 1

Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors

A Phase 1 study of Solid Tumors, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
4
Study locations

NCT01149720 is a Phase 1 study of Solid Tumors that has completed, run by Daiichi Sankyo. The registered enrollment target is 24 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT01149720, a Phase 1 study of Solid Tumors, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
4
Study locations

Study Summary

This is a Phase 1, randomized, open label, 2 treatment, 2 period, 2-way crossover study, with an extension phase design in which the steady state PK of ARQ 197 will be investigated using the tablet administered in fed state (test treatment) and capsule administered at least 1 hour before or 2 hours after a meal (reference treatment) in subjects with advanced solid tumors.

Conditions Studied

Solid Tumors

Interventions

  • DRUG Tivantinib (ARQ 197) Capsule
  • DRUG Tivantinib (ARQ 197) Tablet
  • DRUG Tivantinib (ARQ 197) Capsule D, oral

Study Locations (4)

California

  • Premiere Oncology - Santa Monica

Florida

  • Florida Cancer Specialists - Fort Myers

Tennessee

  • Sarah Cannon Research Institute (SCRI) - Nashville

Texas

  • START - South Texas Accelerated Research Therapeutics, LLC - San Antonio

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2010-07
Est. Completion 2011-03
Phase Phase 1

Sponsor

Daiichi Sankyo

236 total trials

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What the Registry Record Tells You About NCT01149720

The ClinicalTrials.gov registry entry for NCT01149720 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 (92% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 3 interventions - of which Tivantinib (ARQ 197) Capsule is the first listed.

NCT01149720 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Tennessee.

Frequently Asked Questions

What is clinical trial NCT01149720 about?

NCT01149720 is a clinical study titled "Determination of the Relative Bioavailability of ARQ 197 Tablet Formulation With Capsule C Formulation as a Reference in Subjects With Advanced Solid Tumors". This is a Phase 1, randomized, open label, 2 treatment, 2 period, 2-way crossover study, with an extension phase design in which the steady state PK of ARQ 197 will be investigated using the tablet administered in fed state (test treatment) and capsule administered at least 1 hour before or 2 hours ...

What is the current status of trial NCT01149720?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-07. Estimated completion is 2011-03.

What conditions does trial NCT01149720 study?

This clinical trial studies the following conditions: Solid Tumors.

What interventions are being tested in trial NCT01149720?

The interventions under investigation include: Tivantinib (ARQ 197) Capsule (DRUG), Tivantinib (ARQ 197) Tablet (DRUG), Tivantinib (ARQ 197) Capsule D, oral (DRUG).

Who is sponsoring clinical trial NCT01149720?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01149720 being conducted?

This trial has 4 study locations across California, Florida, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.