Oral TRK Inhibitor LOXO-101 for Treatment of Advanced Adult Solid Tumors

Description

This is a multicenter, open-label, Phase 1a/1b study of orally administered LOXO-101 in adult subjects with advanced solid tumors that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists.

Study Start Date

April 2014

Estimated Completion Date

January 2017

Interventions

  • Drug: LOXO-101

Specialties

  • Oncology: Pharmacology/Therapy
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Adult Solid Tumor
  • LOXO-101
  • Neoplasms

Study ID

Loxo Oncology, Inc. -- LOXO-TRK-14001

Status

Unknown

Trial ID

NCT02122913

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

108

Sponsor

Loxo Oncology, Inc.

Phase 1a [Inclusion]
  • Locally advanced or metastatic adult solid tumor that has progressed or was nonresponsive to available therapies and for which no standard or available curative therapy exists
  • ECOG score of 0 or 1
  • Adequate hematologic, hepatic, and renal function
  • Phase 1a [Exclusion] • Prior exposure to a selective TRK-blocking agent Phase 1b [Inclusion]
  • Phase 1a inclusion criteria
  • Tumor that is positive for TRK alteration Phase 1b [Exclusion] • Phase 1a exclusion criteria
  • Gender

    Both

    Ages

    18 Years and older

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (7)

    Study Location Distance Name Phone Email
    University Hospitals Case Medical Center - Cleveland, Ohio 48.3 miles None None None
    University of Pennsylvania - Philadelphia, Pennsylvania 134.5 miles None None None
    Massachusetts General Hospital - Boston, Massachusetts 137.9 miles None None None
    SCRI - Nashville, Tennessee 810.5 miles None None None
    MD Anderson Cancer Center - Houston, Texas 1,475.7 miles None None None
    University of Colorado Cancer Center - Aurora, Colorado 1,658.2 miles None None None
    OHSU - Portland, Oregon 2,468.2 miles None None None

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