TRIAL DETAIL

Study of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors

Drug:
Trial Name:
Study of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors
NCT#:
Conditions:
Sarcoma
Status:
Recruiting
Phase:
2
Start Date 10/01/2015
Age of Trial (yrs) 4
Treatment Phase:
Gleevec-resistant
Drug Category:
TRK Inhibitor
Strategy:
Block related tumor signal paths
Trial Type:
GIST not specified. GIST patient enrollment unknown.
Other Protocol IDs:
LOXO-TRK-15002
Sponsor:
Loxo Oncology, Inc.
Patient Contact:
Patient Advocacy 1-855-NTRK-123 clinicaltrials@loxooncology.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
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 at 100mg twice daily (BID), with each cycle consisting of 28 days of dosing administered on a continuous basis.

The study will include 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.

Incusion Criteria:

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.

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.

Subjects must have at least one measurable lesion as defined by RECIST 1.

Trial Links

Trial Results

 
 

Drug Information

LOXO NTRK
 
LOXO-101
 
Loxo Oncology TRK Inhibitor LOXO-101 Shows Durable Anti-Tumor Activity
 
Transcriptome sequencing identifies ETV6–NTRK3 as a gene fusion involved in GIST
 
SLITRK3 expression correlation to gastrointestinal stromal tumor risk rating and prognosis
 
ARRY-470
 

Trial Sites

Name
Address
City
State
Zip
Country
Palo Alto
CA
94304
USA
1275 York Ave
New York
NY
10065
USA
333 Cottman Ave
Philadelphia
PA
19111
USA
2220 Pierce Ave.
Nashville
TN
37232
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA
Seoul
Republic of Korea
Fairfax
VA
22031
USA
757 Westwood Plaza
Los Angeles
CA
90095
USA
55 Fruit Street
Boston
MA
02114
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
Lebanon
NH
03756
USA
Medical Center Boulevard
Winston-Salem
NC
27157
USA
Cleveland
OH
44195
USA
Seattle
WA
98109
USA
Singapore
Singapore
119-129
Barcelona
08035
Spain
Washington
DC
20010
USA
Pembroke Pines
FL
33028
USA
Philadelphia
PA
19107
USA
Morgantown
WV
26506
USA
Copenhagen
Denmark
Dublin
Ireland
Seoul
Republic of Korea
Hackensack
NJ
07601
USA
Sioux Falls
SD
57105
USA
Madrid
28040
Spain
229 Cours Argonne
Bordeaux
Gironde
33076
France
101 DAEHAK-RO
Seoul
110-774
Republic of Korea
London
NW1 2PG
UK
Buffalo
NY
14263
USA
5841 S. Maryland Ave
Chicago
IL
60637
USA
London
UK
Southampton
S016 6YD
UK
Madrid
28050
Spain
Porto
4200-072
Portugal
Chapel Hill
NC
27157
USA