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Trial record 3 of 6 for:    loxo-101

Study of LOXO-101 (Larotrectinib) in Subjects With NTRK Fusion Positive Solid Tumors (NAVIGATE)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Loxo Oncology, Inc.
Sponsor:
Information provided by (Responsible Party):
Loxo Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT02576431
First received: October 12, 2015
Last updated: May 26, 2017
Last verified: May 2017
  Purpose
Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3.

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung Thyroid Neoplasms Sarcoma Colorectal Neoplasms Salivary Gland Neoplasms Biliary Tract Neoplasms Brain Neoplasm, Primary Carcinoma, Ductal, Breast Melanoma Solid Tumors Glioblastoma Bile Duct Neoplasms Astrocytoma Head and Neck Squamous Cell Carcinoma Pontine Glioma Pancreatic Neoplasms Ovarian Neoplasms Carcinoma, Renal Cell Cholangiocarcinoma Carcinoma Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Drug: LOXO-101 Phase 2

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Basket Study of the Oral TRK Inhibitor LOXO-101 (Larotrectinib) in Subjects With NTRK Fusion-Positive Tumors

Resource links provided by NLM:


Further study details as provided by Loxo Oncology, Inc.:

Primary Outcome Measures:
  • Overall Response Rate of confirmed CR or PR as determined by an Independent Radiology Committee using RECIST 1.1 or RANO criteria [ Time Frame: Up to 30 Months ]

Secondary Outcome Measures:
  • Overall Response Rate of confirmed CR or PR as determined by the treating investigator using RECIST 1.1 or RANO criteria [ Time Frame: Up to 30 months ]
  • Duration of response for subjects with best overall response of confirmed CR or PR by Independent Radiology Committee [ Time Frame: Up to 30 months ]
  • Duration of response for subjects with best overall response of confirmed CR or PR by the treating investigator [ Time Frame: Up to 30 months ]
  • Progression Free Survival [ Time Frame: Up to 30 months ]
    Number of moths from initiation of Loxo-101 to the earlier of diease progression or death due to any cause

  • Overall Survival (OS) [ Time Frame: Through study completion up to 42 months ]
    Number of months from the initiation of LOXO-101 to the date of death due to any cause.

  • Comparison of Progression Free Survival following initiation of Loxo-101 to that following the line of therapy immediately preceding Loxo-101 [ Time Frame: UP to 30 months ]
    In each subject who has received prior therapy

  • Incidence of Adverse Events [ Time Frame: Up to 30 months ]
  • Severity of Adverse Events [ Time Frame: Up to 30 months ]
  • Duration of Adverse Events [ Time Frame: Up to 30 months ]
  • Changes from baseline in clinical safety laboratory values [ Time Frame: Up to 30 months ]
  • Changes from baseline in vital signs [ Time Frame: Up to 30 months ]

Estimated Enrollment: 151
Study Start Date: October 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Non Small Cell Lung Cancer
Adult Solid Tumors Measurable Disease by RECIST 1.1 Oral LOXO-101
Drug: LOXO-101
Oral capsule of LOXO-101 - 100mg BID
Thyroid
Adult Solid Tumors Measurable Disease by RECIST 1.1 Oral LOXO-101
Drug: LOXO-101
Oral capsule of LOXO-101 - 100mg BID
Sarcoma
Adult Solid Tumors Measurable Disease by RECIST 1.1 Oral LOXO-101
Drug: LOXO-101
Oral capsule of LOXO-101 - 100mg BID
Colorectal
Adult Solid Tumors Measurable Disease by RECIST 1.1 Oral LOXO-101
Drug: LOXO-101
Oral capsule of LOXO-101 - 100mg BID
Salivary
Adult Solid Tumors Measurable Disease by RECIST 1.1 Oral LOXO-101
Drug: LOXO-101
Oral capsule of LOXO-101 - 100mg BID
Biliary
Adult Solid Tumors Measurable Disease by RECIST 1.1 Oral LOXO-101
Drug: LOXO-101
Oral capsule of LOXO-101 - 100mg BID
Primary CNS
Brain Tumor Measurable by RANO Oral LOXO-101
Drug: LOXO-101
Oral capsule of LOXO-101 - 100mg BID
All Other Solid Tumors
Tumor Histology not in Cohorts 1-7 Evaluable but not Measurable Disease Oral LOXO-101
Drug: LOXO-101
Oral capsule of LOXO-101 - 100mg BID

Detailed Description:

This is a Phase II, multi-center, open-label study of patients with advanced solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3. Patients with NTRK1, NTRK2 or NTRK3 fusion-positive cancers will be identified through molecular assay.

LOXO-101 will be administered orally at 100mg twice daily (BID), with each cycle consisting of 28 days of dosing administered on a continuous basis.

The study will analyze 8 cohorts of patients with tumors bearing NTRK fusions, including non small cell lung cancer, thyroid cancer, sarcoma, colorectal cancer, salivary gland cancer, biliary cancer and primary CNS tumor, as well as a cohort that will enroll patients not included in the histologies listed above.

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Locally-advanced or metastatic malignancy with an NTRK1, NTRK2 or NTRK3 gene fusion, identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories.
  2. Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinical benefit from appropriate standard of care therapy.
  3. Adequate organ function as defined by the following criteria:

    • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 upper limit of normal (ULN), or AST and ALT < 5 ULN if liver function abnormalities are due to underlying malignancy.
    • Total bilirubin < 2.5 ULN. Subjects with a known history of Gilberts Disease and an isolated elevation of indirect bilirubin are eligible.
    • Serum creatinine < 2.0 ULN OR an estimated glomerular filtration rate ≥ 30 mL/minute using the Cockroft-Gault formula.

Key Exclusion Criteria:

1. Pregnancy or lactation.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02576431

Contacts
Contact: Patient Advocacy 1-855-NTRK-123 clinicaltrials@loxooncology.com

  Show 33 Study Locations
Sponsors and Collaborators
Loxo Oncology, Inc.
Investigators
Study Director: Nora Ku, MD Loxo Oncology
  More Information

Responsible Party: Loxo Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02576431     History of Changes
Other Study ID Numbers: LOXO-TRK-15002
Study First Received: October 12, 2015
Last Updated: May 26, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Loxo Oncology, Inc.:
LOXO-101
NTRK Fusion Positive
Loxo
TRK
TRK Fusion
NTRK1
NTRK2
NTRK3
TRKA
TRKB
TRKC
ETV6
NTRK
larotrectinib
fusion
tumors
CNS tumors
solid tumors
central nervous system tumors
solid CNS tumors
primary CNS tumor
Advanced CNS tumor
Metastatic CNS tumor
NTRK1 fusion
NTRK2 fusion
NTRK3 fusion
ETV6-NTRK3
ETV6 fusion

Additional relevant MeSH terms:
Carcinoma
Neoplasms
Melanoma
Carcinoma, Squamous Cell
Glioblastoma
Astrocytoma
Cholangiocarcinoma
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Lung Neoplasms
Head and Neck Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Brain Neoplasms
Carcinoma, Renal Cell
Thyroid Neoplasms
Biliary Tract Neoplasms
Thoracic Neoplasms
Respiratory Tract Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Carcinoma, Ductal
Bile Duct Neoplasms
Salivary Gland Neoplasms
Carcinoma, Ductal, Breast
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroendocrine Tumors

ClinicalTrials.gov processed this record on June 23, 2017