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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: Completed Phase 1 study of Solid Tumors, sponsored by Daiichi Sankyo.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoints are the area under the concentration time curve from time of dosing until 12 hours post-dose (AUC0-12) and maximum observed concentration in plasma (Cmax) of ARQ 197 following the administration of the tablet (fed conditions) and capsule formulation (at least 1 hour before or 2 hours after a meal).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
What the finished NCT01149720 record still lists
NCT01149720 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01149720's enrollment target sits among peer trials
24 112th of 125 higher than 14 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
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Study of AUBE00 in Patients With Solid Tumors
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