Breast Cancer Clinical Trial
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)
Summary
This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.
Eligibility Criteria
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
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
Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed
Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements)
- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy
At least 4 weeks must have elapsed since completion of antibody-directed therapy
Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and minimum life expectancy of 4 weeks
Adequate organ function as defined per protocol
Ability to swallow entrectinib intact
Other protocol specified criteria
Exclusion Criteria:
Current participation in another therapeutic clinical trial
Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements
- Note: prior treatment with crizotinib is permitted only in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression. Other ALK inhibitors are prohibited.
History of other previous cancer that would interfere with the determination of safety or efficacy
Familial or personal history of congenital bone disorders, or bone metabolism alterations
Incomplete recovery from any surgery
History of recent (within the past 3 months) symptomatic congestive heart failure or ejection fraction ≤50% observed during screening for the study
History of non-pharmacologically induced prolonged QTc interval
History of additional risk factors for torsades de pointes
Peripheral neuropathy Grade ≥ 2
Known active infections
Active gastrointestinal disease or other malabsorption syndromes
Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
Other protocol specified criteria
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There are 119 Locations for this study
Phoenix Arizona, 85013, United States
Scottsdale Arizona, 85259, United States
Duarte California, 91010, United States
La Jolla California, 92037, United States
La Jolla California, 92093, United States
Los Angeles California, 90033, United States
Orange California, 92868, United States
San Diego California, 92108, United States
San Francisco California, 94115, United States
Santa Monica California, 90403, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06510, United States
Washington District of Columbia, 20007, United States
Sarasota Florida, 34232, United States
Tampa Florida, 33612, United States
Athens Georgia, 30607, United States
Atlanta Georgia, 30322, United States
Newnan Georgia, 30265, United States
Chicago Illinois, 60611, United States
Park Ridge Illinois, 60068, United States
Zion Illinois, 60099, United States
Baltimore Maryland, 21237, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Minneapolis Minnesota, 55455, United States
Saint Louis Missouri, 63128, United States
Las Vegas Nevada, 89169, United States
East Setauket New York, 11733, United States
New York New York, 11101, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Columbus Ohio, 43210, United States
Tulsa Oklahoma, 74133, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19124, United States
Dallas Texas, 75230, United States
Houston Texas, 77030, United States
Temple Texas, 76502, United States
Salt Lake City Utah, 84132, United States
Fairfax Virginia, 22031, United States
Hampton Virginia, 23666, United States
Seattle Washington, 98195, United States
Liverpool New South Wales, 2170, Australia
New Lambton Heights New South Wales, 2305, Australia
Bedford Park South Australia, 5042, Australia
Heidelberg Victoria, 3084, Australia
Edegem , 2650, Belgium
Beijing , 10014, China
Chengdu , 61004, China
Guangzhou , 51000, China
Harbin , 15008, China
Shanghai City , 20012, China
Shanghai , 20003, China
Shenzhen , 51085, China
Tianjin , 30006, China
Wuhan City , 43002, China
Zhejiang , 31002, China
Angers , 49055, France
Bordeaux , 33076, France
Lyon , 69373, France
Marseille cedex 5 , 13385, France
Marseille , 13015, France
Montpellier cedex 5 , 34298, France
Paris , 75231, France
Saint Herblain , 44805, France
Toulouse , 31059, France
Villejuif cedex , 94805, France
Berlin , 13125, Germany
Dresden , 01307, Germany
Göttingen , 37075, Germany
Heidelberg , 69120, Germany
Köln , 50937, Germany
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Kowloon , , Hong Kong
Shatin , 12345, Hong Kong
Napoli Campania, 80131, Italy
Roma Lazio, 128, Italy
Milano Lombardia, 20133, Italy
Milano Lombardia, 20162, Italy
Pisa Toscana, 56126, Italy
Perugia Umbria, 6132, Italy
Padova Veneto, 35128, Italy
Aichi , 464-8, Japan
Ehime , 791-0, Japan
Fukuoka , 811-1, Japan
Hyogo , 673-8, Japan
Kashiwa-shi , 277-8, Japan
Miyagi , 981-1, Japan
Niigata , 951-8, Japan
Osaka , 534-0, Japan
Osaka , 589-8, Japan
Shizuoka , 411-8, Japan
Seoul , 003-7, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 5505, Korea, Republic of
Amsterdam , 1066 , Netherlands
Leiden , 2333 , Netherlands
Gda?sk , 80-21, Poland
Gliwice , 44-10, Poland
Pozna? , 60-56, Poland
Warszawa , 02-78, Poland
Singapore , 11907, Singapore
Singapore , 16961, Singapore
Fuenlabrada Madrid, 28942, Spain
Barcelona , 08035, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Sevilla , 41013, Spain
Tainan , 70457, Taiwan
Taipei City , 11217, Taiwan
Taipei , 10002, Taiwan
Cambridge , CB2 0, United Kingdom
London , W1G 6, United Kingdom
Manchester , M2O 4, United Kingdom
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