Phase 1 Study of LOXO-292 in Patients With Advanced Solid Tumors, RET-Fusion Lung Cancer and Medullary Thyroid Cancer

Description

This is a Phase 1, open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of LOXO-292 administered orally to patients with advanced solid tumors, including RET-fusion non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other tumors with increased RET activity.

Study Start Date

May, 09 2017

Estimated Completion Date

December 2019

Interventions

  • Drug: LOXO-292

Study ID

Loxo Oncology, Inc. -- LOXO-RET-17001

Status

Recruiting

Trial ID

NCT03157128

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

105

Sponsor

Loxo Oncology, Inc.

Key

Inclusion Criteria

  • Diagnosis during Dose Escalation (Part 1)
  • Locally advanced or metastatic solid tumor refractory to standard of care therapy, or for whom no standard of care therapy is available, or who in the opinion of the Investigator, is not a candidate for, or would be unlikely to tolerate or derive significant clinical benefit from standard of care therapy.
  • Once a safe dose level is achieved that is consistent with inhibiting RET, patients must have advanced NSCLC, MTC or other advanced solid tumor with evidence of RET alteration or other evidence of increased RET activity in tumor tissue and/or blood.
  • Any number of prior TKIs.
  • Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate to tumor type.
  • Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
  • Adequate hematologic, hepatic and renal function.
  • Life expectancy of at least 3 months.

    Inclusion Criteria

    • Diagnosis during Dose Expansion (Part 2)
    • Group 1: Advanced RET-fusion NSCLC with ? 1 prior tyrosine kinase inhibitor (TKI) that inhibit RET
    • Group 2: Advanced RET-fusion NSCLC with no prior TKI that inhibits RET
    • Group 3: Advanced RET-mutant MTC with ? 1 prior TKI that inhibit RET
    • Group 4: Advanced RET-mutant MTC with no prior TKI that inhibits RET
    • Group 5: Disease not measurable, other RET-altered tumors, other RET alterations, cfDNA positive for RET alteration with tumor discordant or negative, RET mutation-negative MTC with any number of prior TKIs that inhibit RET
    • For MTC: PD within the previous 14 months as defined by RECIST 1.1.
    • Any number of prior TKIs.
    • At least one measurable lesion as defined by RECIST 1.1 or RANO, as appropriate to tumor type, not previously irradiated and not chosen for biopsy during the screening period. Patients without RECIST 1.1 or RANO measurable disease may be eligible for enrollment to Group 5.
    • ECOG score of 0, 1, or 2.
    • Adequate hematologic, hepatic and renal function.
    • Life expectancy of at least 3 months. Key Exclusion Criteria (Dose Escalation and Dose Expansion):
    • For NSCLC patients, a targetable mutation in EGFR, or targetable rearrangement involving ALK or ROS1.
    • Investigational agent or anticancer therapy within 2 weeks (14 days) prior to planned start of LOXO-292.
    • Major surgery (excluding placement of vascular access) within 4 weeks prior to planned start of LOXO-292.
    • Radiotherapy with a limited field of radiation for palliation within 1 week of planned start of LOXO-292, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study treatment.
    • Symptomatic primary CNS tumor or metastases (stable CNS tumor/metastases is allowed).
    • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292 or prolongation of the QT interval corrected (QTcF) > 470 msec.
    • Required treatment with certain strong CYP3A4 inhibitors or inducers.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (25)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles None None None
DanaFarber Cancer Institute - Boston, Massachusetts 2.6 miles None None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles None None None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles None None None
Cleveland Clinic - Cleveland, Ohio 544.9 miles None None None
The James Cancer Hospital and Solove Research Institute The Ohio State University Comprehensive Cancer Center - Columbus, Ohio 644.2 miles None None None
The James Cancer Hospital and Solove Research Institute The Ohio State University Comprehensive Cancer Center - Columbus, Ohio 644.2 miles None None None
The James Cancer Hospital and Solove Research Institute The Ohio State University Comprehensive Cancer Center - Columbus, Ohio 644.2 miles None None None
The James Cancer Hospital and Solove Research Institute The Ohio State University Comprehensive Cancer Center - Columbus, Ohio 644.2 miles None None None
The James Cancer Hospital and Solove Research Institute The Ohio State University Comprehensive Cancer Center - Columbus, Ohio 644.2 miles None None None
South Texas Accelerated Research Therapeutics START Midwest - Grand Rapids, Michigan 741.6 miles None None None
South Texas Accelerated Research Therapeutics START Midwest - Grand Rapids, Michigan 741.6 miles None None None
South Texas Accelerated Research Therapeutics START Midwest - Grand Rapids, Michigan 741.6 miles None None None
South Texas Accelerated Research Therapeutics START Midwest - Grand Rapids, Michigan 741.6 miles None None None
South Texas Accelerated Research Therapeutics START Midwest - Grand Rapids, Michigan 741.6 miles None None None
University of Chicago Medicine - Chicago, Illinois 848.0 miles None None None
Sarah Cannon Research Institute LLC - Nashville, Tennessee 942.8 miles None None None
Sarah Cannon Research Institute LLC - Nashville, Tennessee 942.8 miles None None None
Sarah Cannon Research Institute LLC - Nashville, Tennessee 942.8 miles None None None
Sarah Cannon Research Institute LLC - Nashville, Tennessee 942.8 miles None None None
Sarah Cannon Research Institute LLC - Nashville, Tennessee 942.8 miles None None None
MD Anderson Cancer Center - Houston, Texas 1,609.9 miles None None None

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