Phase 1/2 Study of LOXO-195 in Patients With Previously Treated NTRK Fusion Cancers



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Colorectal Cancer, Skin Cancer, Ovarian Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer, Brain Cancer, Brain Cancer, Brain Cancer, Neurology, Endocrine, Thyroid Cancer
Therapuetic Areas:Endocrinology, Neurology, Oncology
Healthy:No
Age Range:Any
Updated:1/27/2019
Start Date:July 10, 2017
End Date:December 2019
Contact:Patient Advocacy
Email:clinicaltrials@loxooncology.com
Phone:1-855-NTRK-123

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A Phase 1/2 Study of the TRK Inhibitor LOXO-195 in Adult and Pediatric Subjects With Previously Treated NTRK Fusion Cancers

This is a Phase 1/2, multi-center, open-label study designed to evaluate the safety and
efficacy of LOXO-195 when administered orally to patients age ≥ 1 month and older with NTRK
fusion cancers treated with a prior TRK inhibitor.

The trial will be conducted in 2 parts: dose escalation (Phase I ) and dose expansion (Phase
2) . Patients with unresectable or metastatic solid tumors are eligible if progressed or
intolerant to prior TRK inhibitor. During Phase 1, a maximum tolerated dose (MTD)/recommended
dose for further study will be identified for in patients age 12 and older and patients age
<12. During Phase 2, the same patient population as designated for Phase 1 will be treated
with the dose of LOXO-195 which has been identified during phase 1 to assess specified
endpoints.

Key Inclusion Criteria:

- Advanced solid tumor for which, in the opinion of the Investigator, no other standard
therapy offers greater benefit.

- A solid tumor diagnosis in the setting of:

1. a documented NTRK fusion and a clinical history of relapse following a response
to a prior TRK inhibitor

2. a documented NTRK fusion unresponsive to a prior TRK inhibitor

3. a documented NTRK fusion and a clinical history of intolerance to a prior TRK
inhibitor

- NTRK gene fusions will be identified via a CLIA certified (or equivalent) laboratory.
Exception: Patients with Infantile Fibrosarcoma (IFS) and congenital mesoblastic
nephroma (CMN) may be enrolled based on ETV6+ FISH test without identifying NTRK3

- Performance Status: Eastern Cooperative Oncology Group (ECOG) score ≤ 3 (age ≥16) or
Lansky Performance Score (LPS) ≥40% (age<16). If enrolled with primary CNS tumor to be
assessed by RANO, Karnofsky Performance Status (KPS) (age ≥16) or LPS (age<16) ≥ 50%

- Life expectancy > 4 weeks

- Adequate hematologic, hepatic and renal function.

- Patients with stable CNS primary tumor, brain metastases, or treated spinal cord
compression are eligible if neurological symptoms and steroid use (if applicable) have
been stable for 7 days prior to the first dose of LOXO-195

- Ability to receive study drug orally or by enteral administration

Key Exclusion Criteria:

- Required treatment with certain strong CYP3A4 inhibitors or inducers.

- Clinically significant active cardiovascular disease or history of myocardial
infarction within 3 months prior to planned start of LOXO-195 or prolongation of the
QT interval corrected (QTcF) > 480 msec within the past 6 months

- Major surgery within 7 days of enrollment

- Uncontrolled systemic bacterial, fungal or viral infection

- Pregnancy or lactation.

- Known hypersensitivity to any of the components of LOXO-195 or Ora-Sweet® SF and
OraOlus, for patients receiving liquid suspension
We found this trial at
12
sites
Houston, Texas 77030
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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Denver, CO
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Norfolk, VA
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Randwick,
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Seattle, Washington 98115
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Seattle, WA
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Stanford, California 94305
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Stanford, CA
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