NCT01149720

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

June 22, 2010

Last Update Submit

February 8, 2019

Conditions

Solid Tumors

Keywords

Relative bioavailabilityARQ 197

Outcome Measures

Primary Outcomes (1)

  • Determination of the relative bioavailability of ARQ 197 tablet formulation with capsule C formulation

    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).

    14 days

Secondary Outcomes (1)

  • Assessment of additional pharmacokinetic parameters of ARQ 197 tablet formulation and capsule C formulation

    14 days

Study Arms (3)

ARQ 197 Capsule, oral

EXPERIMENTAL

Oral BID 360 mg dose (Capsule C: 6 X 60 mg) of ARQ 197 at least 1 hour before or 2 hours after a meal for 7 days

Drug: Tivantinib (ARQ 197) Capsule

ARQ 197 Tablet, oral

EXPERIMENTAL

Oral BID 360 mg dose (Tablet: 3 x 120 mg) of ARQ 197 under fed conditions for 7 days

Drug: Tivantinib (ARQ 197) Tablet

ARQ 197 Capsule D, oral

EXPERIMENTAL

Oral BID 360 mg dose (Capsule D: 3 x 120 mg) of ARQ 197 under fed conditions in the extension phase

Drug: Tivantinib (ARQ 197) Capsule D, oral

Interventions

Tivantinib (ARQ 197) CapsuleDRUG

Oral BID 360 mg dose (Capsule C: 6 X 60 mg) of ARQ 197 at least 1 hour before or 2 hours after a meal for 7 days

Also known as: Tivantinib
ARQ 197 Capsule, oral
Tivantinib (ARQ 197) TabletDRUG

Oral BID 360 mg dose (Tablet: 3 x 120 mg) of ARQ 197 under fed conditions for 7 days

Also known as: Tivantinib
ARQ 197 Tablet, oral
Tivantinib (ARQ 197) Capsule D, oralDRUG

Oral BID 360 mg dose (Capsule D: 3 x 120 mg) of ARQ 197 under fed conditions in the extension phase

Also known as: Tivantinib
ARQ 197 Capsule D, oral

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have a histologically or cytologically confirmed advanced solid tumor at screening.
  • Male or female equal or greater than 18 years of age.
  • All female subjects of childbearing potential must each have a negative serum pregnancy test result before initiating study treatment.
  • An Eastern Cooperative Oncology Group (ECOG) performance status equal or less than 2
  • Adequate bone marrow, liver, and renal function, defined as:
  • Platelet count equal or greater than 75 x 10(9)/L
  • Hemoglobin (Hb) equal or greater than 9.0 g/dL
  • Absolute neutrophil count (ANC) equal or greater than 1.5 x 10(9)/L
  • Total bilirubin equal or less than 1.5 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) equal or less than 3 x ULN (equal or less than 5 x ULN for subjects with liver metastases)
  • Serum creatinine equal or less than 1.5 x ULN

You may not qualify if:

  • History of cardiac disease: Active coronary artery disease (CAD), defined as myocardial infarction (MI), unstable angina, coronary bypass graft (CABG), or stenting within 6 months prior to study entry (an MI that occurred \> 6 months prior to study entry is permitted)
  • Evidence of uncontrolled bradycardia or other cardiac arrhythmia defined as equal or greater than Grade 2 according to NCI CTCAE, version 4.0, or uncontrolled hypertension
  • Active, clinically serious infection(s) defined as equal or greater than Grade 2 according to NCI CTCAE, version 4.0.
  • Known metastatic brain or meningeal tumors, unless the subject is \> 3 months from definitive therapy and clinically stable (supportive therapy with steroids or anticonvulsant medications is allowed) with respect to the tumor at the time of first dose of study drug.
  • Prior therapy with mesenchymal-epithelial transition factor (c-MET) inhibitors, including ARQ 197.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Premiere Oncology

Santa Monica, California, 90404, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

Sarah Cannon Research Institute (SCRI)

Nashville, Tennessee, 37203, United States

Location

START - South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

ARQ 197CapsulesTablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2010

First Posted

June 23, 2010

Study Start

July 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

February 12, 2019

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
More information

Locations

US(4)