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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02568267




Registration number
NCT02568267
Ethics application status
Date submitted
2/10/2015
Date registered
5/10/2015
Date last updated
30/06/2020

Titles & IDs
Public title
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)
Scientific title
An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
Secondary ID [1] 0 0
2015-003385-84
Secondary ID [2] 0 0
RXDX-101-02
Universal Trial Number (UTN)
Trial acronym
STARTRK-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Cholangiocarcinoma 0 0
Colorectal Cancer 0 0
Head and Neck Neoplasms 0 0
Lymphoma, Large-Cell, Anaplastic 0 0
Melanoma 0 0
Neuroendocrine Tumors 0 0
Non-Small Cell Lung Cancer 0 0
Ovarian Cancer 0 0
Pancreatic Cancer 0 0
Papillary Thyroid Cancer 0 0
Primary Brain Tumors 0 0
Renal Cell Carcinoma 0 0
Sarcomas 0 0
Salivary Gland Cancers 0 0
Adult Solid Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Pancreatic
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Thyroid
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Head and neck
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Entrectinib

Experimental: NTRK1/2/3-rearranged NSCLC - Oral entrectinib (RXDX-101)

Experimental: ROS1-rearranged NSCLC - Oral entrectinib (RXDX-101)

Experimental: ALK- or ROS1-rearranged NSCLC - with CNS-only progression previously treated with crizotinib (NOTE: The ALK-rearranged portion of this arm is now closed to enrollment.)
Oral entrectinib (RXDX-101)

Experimental: NTRK/1/2/3-rearranged mCRC - Oral entrectinib (RXDX-101)

Experimental: ROS1-rearranged mCRC - Oral entrectinib (RXDX-101)

Experimental: ALK-rearranged mCRC - Oral entrectinib (RXDX-101)

Experimental: NTRK1/2/3-rearranged other solid tumor - Oral entrectinib (RXDX-101)

Experimental: ROS1-rearranged other solid tumor - Oral entrectinib (RXDX-101)

Experimental: ALK-rearranged other solid tumor - Oral entrectinib (RXDX-101)


Treatment: Drugs: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate - Assessed by blinded independent central review (BICR) using RECIST v1.1
Timepoint [1] 0 0
Approximately 24 months
Secondary outcome [1] 0 0
Duration of Response - Assessed by blinded independent central review (BICR) using RECIST v1.1
Timepoint [1] 0 0
Approximately 24 months
Secondary outcome [2] 0 0
Time to Response - Assessed by blinded independent central review (BICR) using RECIST v1.1
Timepoint [2] 0 0
Approximately 24 months
Secondary outcome [3] 0 0
Clinical Benefit Rate - Assessed by blinded independent central review (BICR) using RECIST v1.1
Timepoint [3] 0 0
Approximately 24 months
Secondary outcome [4] 0 0
Intracranial Tumor Response - Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
Timepoint [4] 0 0
Approximately 24 months
Secondary outcome [5] 0 0
CNS Progression-free Survival - Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
Timepoint [5] 0 0
Approximately 24 months
Secondary outcome [6] 0 0
Progression-free Survival - Assessed by Kaplan-Meier method
Timepoint [6] 0 0
Approximately 30 months
Secondary outcome [7] 0 0
Overall Survival - Assessed by Kaplan-Meier method
Timepoint [7] 0 0
Approximately 36 months

Eligibility
Key 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

- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Hampshire
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Belgium
State/province [28] 0 0
Edegem
Country [29] 0 0
China
State/province [29] 0 0
Beijing
Country [30] 0 0
China
State/province [30] 0 0
Chengdu
Country [31] 0 0
China
State/province [31] 0 0
Harbin
Country [32] 0 0
China
State/province [32] 0 0
Shanghai
Country [33] 0 0
China
State/province [33] 0 0
Tianjin
Country [34] 0 0
China
State/province [34] 0 0
Wuhan City
Country [35] 0 0
China
State/province [35] 0 0
Zhejiang
Country [36] 0 0
France
State/province [36] 0 0
Angers
Country [37] 0 0
France
State/province [37] 0 0
Bordeaux
Country [38] 0 0
France
State/province [38] 0 0
Lille
Country [39] 0 0
France
State/province [39] 0 0
Lyon
Country [40] 0 0
France
State/province [40] 0 0
Marseille cedex 5
Country [41] 0 0
France
State/province [41] 0 0
Marseille
Country [42] 0 0
France
State/province [42] 0 0
Montpellier cedex 5
Country [43] 0 0
France
State/province [43] 0 0
Paris cedex 15
Country [44] 0 0
France
State/province [44] 0 0
Paris
Country [45] 0 0
France
State/province [45] 0 0
Saint Herblain
Country [46] 0 0
France
State/province [46] 0 0
Toulouse
Country [47] 0 0
France
State/province [47] 0 0
Villejuif cedex
Country [48] 0 0
Germany
State/province [48] 0 0
Berlin
Country [49] 0 0
Germany
State/province [49] 0 0
Dresden
Country [50] 0 0
Germany
State/province [50] 0 0
Gauting
Country [51] 0 0
Germany
State/province [51] 0 0
Göttingen
Country [52] 0 0
Germany
State/province [52] 0 0
Heidelberg
Country [53] 0 0
Germany
State/province [53] 0 0
Köln
Country [54] 0 0
Hong Kong
State/province [54] 0 0
Hong Kong
Country [55] 0 0
Hong Kong
State/province [55] 0 0
Kowloon
Country [56] 0 0
Hong Kong
State/province [56] 0 0
Shatin
Country [57] 0 0
Italy
State/province [57] 0 0
Campania
Country [58] 0 0
Italy
State/province [58] 0 0
Lazio
Country [59] 0 0
Italy
State/province [59] 0 0
Liguria
Country [60] 0 0
Italy
State/province [60] 0 0
Lombardia
Country [61] 0 0
Italy
State/province [61] 0 0
Piemonte
Country [62] 0 0
Italy
State/province [62] 0 0
Toscana
Country [63] 0 0
Italy
State/province [63] 0 0
Umbria
Country [64] 0 0
Italy
State/province [64] 0 0
Veneto
Country [65] 0 0
Japan
State/province [65] 0 0
Aichi
Country [66] 0 0
Japan
State/province [66] 0 0
Ehime
Country [67] 0 0
Japan
State/province [67] 0 0
Fukuoka
Country [68] 0 0
Japan
State/province [68] 0 0
Hyogo
Country [69] 0 0
Japan
State/province [69] 0 0
Kashiwa-shi
Country [70] 0 0
Japan
State/province [70] 0 0
Miyagi
Country [71] 0 0
Japan
State/province [71] 0 0
Niigata
Country [72] 0 0
Japan
State/province [72] 0 0
Osaka
Country [73] 0 0
Japan
State/province [73] 0 0
Shizuoka
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Cheongju-si
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Seoul
Country [76] 0 0
Netherlands
State/province [76] 0 0
Amsterdam
Country [77] 0 0
Netherlands
State/province [77] 0 0
Leiden
Country [78] 0 0
Poland
State/province [78] 0 0
Gdansk
Country [79] 0 0
Poland
State/province [79] 0 0
Gliwice
Country [80] 0 0
Poland
State/province [80] 0 0
Otwock
Country [81] 0 0
Poland
State/province [81] 0 0
Poznan
Country [82] 0 0
Poland
State/province [82] 0 0
Warszawa
Country [83] 0 0
Singapore
State/province [83] 0 0
Singapore
Country [84] 0 0
Spain
State/province [84] 0 0
Madrid
Country [85] 0 0
Spain
State/province [85] 0 0
Barcelona
Country [86] 0 0
Spain
State/province [86] 0 0
Malaga
Country [87] 0 0
Spain
State/province [87] 0 0
Sevilla
Country [88] 0 0
Taiwan
State/province [88] 0 0
Chang Hua
Country [89] 0 0
Taiwan
State/province [89] 0 0
Taichung
Country [90] 0 0
Taiwan
State/province [90] 0 0
Tainan
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taipei City
Country [92] 0 0
Taiwan
State/province [92] 0 0
Taipei
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Cambridge
Country [94] 0 0
United Kingdom
State/province [94] 0 0
London
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02568267
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GO40782 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02568267