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An Open-Label, Phase 1, Randomized, Two-Treatment, Two-Period, Two-Way Crossover, Relative Bioavailability Study Of A Capsule And A Tablet Formulation Of ARQ 197 In Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

An Open-Label, Phase 1, Randomized, Two-Treatment, Two-Period, Two-Way Crossover, Relative Bioavailability Study Of A Capsule And A Tablet Formulation Of ARQ 197 In Subjects With Advanced Solid Tumors


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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).

Outcome Time Frame:

14 days

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

ARQ 197-A-U157

NCT ID:

NCT01149720

Start Date:

July 2010

Completion Date:

March 2011

Related Keywords:

  • Solid Tumors
  • Relative bioavailability
  • ARQ 197
  • Neoplasms

Name

Location

Florida Cancer SpecialistsFort Myers, Florida  33901
Premiere OncologySanta Monica, California  90404
Sarah Cannon Research Institute (SCRI)Nashville, Tennessee  37203
START - South Texas Accelerated Research Therapeutics, LLCSan Antonio, Texas  78229