TRIAL DETAIL

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK1/2/3, ROS1, or ALK Gene Rearrangements (Fusions) (STARTRK-2)

Drug:
Trial Name:
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK1/2/3, ROS1, or ALK Gene Rearrangements (Fusions) (STARTRK-2)
NCT#:
Conditions:
Sarcoma
Status:
Recruiting
Phase:
2
Start Date 10/01/2015
Age of Trial (yrs) 5.2
Treatment Phase:
All
Drug Category:
TRK Inhibitor
Strategy:
Block related tumor signal paths
Trial Type:
GIST not specified. GIST patient enrollment unknown.
Other Protocol IDs:
RXDX-101-02 2015‐003385‐84 ( EudraCT Number ) GO40782 ( Other Identifier: Hoffman-La Roche )
Sponsor:
Hoffmann-La Roche
Patient Contact:
Reference Study ID Number: GO40782 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Inclusion Criteria:

Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement

- Note: Patients diagnosed with anaplastic large cell lymphoma (ALCL) harboring a gene rearrangement of interest may be eligible provided they meet all other inclusion/exclusion criteria
For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment
Measurable or evaluable disease

Trial Links

Trial Results

Drug Information

Selleckchem
 
Ignyta AACR 2016
 
ESMO Sept., 2015
 
Transcriptome sequencing identifies ETV6–NTRK3 as a gene fusion involved in GIST
 
SLITRK3 expression correlation to gastrointestinal stromal tumor risk rating and prognosis
 

Trial Sites

Name
Address
City
State
Zip
Country
1500 E. Duarte Road
Duarte
CA
91010
USA
La Jolla
CA
92093
USA
2811 Wilshire Blvd
Santa Monica
CA
90403
USA
1665 N. Ursula St.
Aurora
CO
80045
USA
Washington
DC
20007
USA
12902 Magnolia Dr.
Tampa
FL
33612
USA
Athens
GA
30607
USA
1365C Clifton Road
Atlanta
GA
30322
USA
1700 Luther Ln
Park Ridge
IL
60068
USA
55 Fruit Street
Boston
MA
02114
USA
1500 East Medical Center Dr
Ann Arbor
MI
48109
USA
4100 John R
Detroit
MI
48201
USA
Detroit
MI
48202
USA
Minneapolis
MN
55455
USA
660 S. Euclid Ave
St. Louis
MO
63110
USA
Lebanon
NH
03756
USA
1275 York Ave
New York
NY
10065
USA
Cleveland
OH
44195
USA
300 W. 10th Ave.
Columbus
OH
43210
USA
Portland
OR
97239
USA
Hamburg
22767
Germany
Fairfax
VA
22031
USA
Goodyear
AZ
85338
USA
La Jolla
CA
92037
USA
Orange
CA
92868
USA
Panorama City
CA
91402
USA
San Francisco
CA
94143
USA
Newnan
GA
30265
USA
Zion
IL
60099
USA
East Setauket
NY
11733
USA
Tulsa
OK
74133
USA
Philadelphia
PA
19124
USA
Seattle
WA
98109
USA
Franklin
WI
53132
USA