TriangleNCT02568267 · CITED IN SOURCE DOCUMENTS
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)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-08-25
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Oral entrectinib (RXDX-101)
- intervention Names
- Drug: Entrectinib
- label
- NTRK1/2/3-rearranged NSCLC
- type
- EXPERIMENTAL
- description
- Oral entrectinib (RXDX-101)
- intervention Names
- Drug: Entrectinib
- label
- ROS1-rearranged NSCLC
- type
- EXPERIMENTAL
- description
- 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)
- intervention Names
- Drug: Entrectinib
- label
- ALK- or ROS1-rearranged NSCLC
- type
- EXPERIMENTAL
- description
- Oral entrectinib (RXDX-101)
- intervention Names
- Drug: Entrectinib
- label
- NTRK/1/2/3-rearranged mCRC
- type
- EXPERIMENTAL
- description
- Oral entrectinib (RXDX-101)
- intervention Names
- Drug: Entrectinib
- label
- ROS1-rearranged mCRC
- type
- EXPERIMENTAL
- description
- Oral entrectinib (RXDX-101)
- intervention Names
- Drug: Entrectinib
- label
- ALK-rearranged mCRC
- type
- EXPERIMENTAL
- description
- Oral entrectinib (RXDX-101)
- intervention Names
- Drug: Entrectinib
- label
- NTRK1/2/3-rearranged other solid tumor
- type
- EXPERIMENTAL
- description
- Oral entrectinib (RXDX-101)
- intervention Names
- Drug: Entrectinib
- label
- ROS1-rearranged other solid tumor
- type
- EXPERIMENTAL
- description
- Oral entrectinib (RXDX-101)
- intervention Names
- Drug: Entrectinib
- label
- ALK-rearranged other solid tumor
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- ALK- or ROS1-rearranged NSCLC
- ALK-rearranged mCRC
- ALK-rearranged other solid tumor
- NTRK/1/2/3-rearranged mCRC
- NTRK1/2/3-rearranged NSCLC
- NTRK1/2/3-rearranged other solid tumor
- ROS1-rearranged NSCLC
- ROS1-rearranged mCRC
- ROS1-rearranged other solid tumor
- description
- TrkA/B/C, ROS1, and ALK inhibitor
- name
- Entrectinib
- other Names
- RXDX-101
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 534
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Assessed by blinded independent central review (BICR) using RECIST v1.1
- measure
- Objective Response Rate
- time Frame
- Approximately 24 months
- secondary Outcomes
- description
- Assessed by blinded independent central review (BICR) using RECIST v1.1
- measure
- Duration of Response
- time Frame
- Approximately 24 months
- description
- Assessed by blinded independent central review (BICR) using RECIST v1.1
- measure
- Time to Response
- time Frame
- Approximately 24 months
- description
- Assessed by blinded independent central review (BICR) using RECIST v1.1
- measure
- Clinical Benefit Rate
- time Frame
- Approximately 24 months
- description
- Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
- measure
- Intracranial Tumor Response
- time Frame
- Approximately 24 months
- description
- Assessed by blinded independent central review (BICR) using RANO or RANO-BM, as applicable
- measure
- CNS Progression-free Survival
- time Frame
- Approximately 24 months
- description
- Assessed by Kaplan-Meier method
- measure
- Progression-free Survival
- time Frame
- Approximately 30 months
- description
- Assessed by Kaplan-Meier method
- measure
- Overall Survival
- time Frame
- Approximately 36 months
- description
- Assessed by Kaplan-Meier method
- measure
- Population PK
- time Frame
- Approximately 24 months
- description
- Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities, graded by the NCI CTCAE
- measure
- Adverse Events
- time Frame
- Approximately 36 months
- description
- Assessed with the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the Euro-QoL Group EQ-5D. NSCLC and mCRC patients will complete the lung cancer and colorectal cancer specific modules, QLQ-LC13 and QLQ-CR29, respectively
- measure
- Quality of Life
- time Frame
- Approximately 24 months
- description
- Assessed with DHA scans
- measure
- Bone Growth and Bone Mineral Density
- time Frame
- Approximately 30 months
- description
- Measured by blood
- measure
- Bone Biomarkers
- time Frame
- Approximately 30 months
Full study description
- 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.
Source references
- references
- citation
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- Desai AV, Bagchi A, Armstrong AE, van Tilburg CM, Basu EM, Robinson GW, Wang H, Casanova M, Andre N, Campbell-Hewson Q, Wu Y, Cardenas A, Ci B, Ryklansky C, Devlin CE, Meneses-Lorente G, Wulff J, Hutchinson KE, Gajjar A, Fox E. Efficacy and safety of entrectinib in children with extracranial solid or central nervous system (CNS) tumours harbouring NTRK or ROS1 fusions. Eur J Cancer. 2025 May 2;220:115308. doi: 10.1016/j.ejca.2025.115308. Epub 2025 Feb 22.
- pmid
- 40086048
- type
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- citation
- Yu Y, Fan Y, Dong X, Li J, Yu Y, Zhao J, Tao S, Chen Y, Chen M, Liu Y, Xu J, Zhu Q, Hu X, Lu S. Entrectinib versus crizotinib in Asian patients with ROS1-positive non-small cell lung cancer: A matching-adjusted indirect comparison. Lung Cancer. 2024 Dec;198:108018. doi: 10.1016/j.lungcan.2024.108018. Epub 2024 Nov 10.
- pmid
- 39549678
- type
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- citation
- Choudhury NJ, Jun Woo H, Chen M, Shah R, Donoghue M, Berger M, Drilon A. Serial Cell-Free DNA Sequencing in ROS1 Fusion-Positive Lung Cancers During Treatment With Entrectinib. JCO Precis Oncol. 2024 Jun;8:e2300721. doi: 10.1200/PO.23.00721.
- pmid
- 38848521
- type
- DERIVED
- citation
- Yokota T, Yukino H, Doi M, Ohori H. Real-world experience of tropomyosin receptor kinase inhibition with entrectinib in ETV6-NTRK3 positive metastatic salivary secretory carcinoma: A case series. Head Neck. 2023 May;45(5):E10-E15. doi: 10.1002/hed.27346. Epub 2023 Mar 16.
- pmid
- 36924196
- type
- DERIVED
- citation
- Sullivan WG, Hatswell AJ. Letter re: 'Intrapatient comparisons of efficacy in a single-arm trial of entrectinib in tumour-agnostic indications'. ESMO Open. 2021 Dec;6(6):100282. doi: 10.1016/j.esmoop.2021.100282. Epub 2021 Oct 28. No abstract available.
- pmid
- 34924145
- type
- DERIVED
- citation
- Doebele RC, Perez L, Trinh H, Martinec M, Martina R, Riehl T, Krebs MG, Meropol NJ, Wong WB, Crane G. Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC. J Comp Eff Res. 2021 Dec;10(17):1271-1282. doi: 10.2217/cer-2021-0131. Epub 2021 Aug 24.
- pmid
- 34427452
- type
- DERIVED
- citation
- Dziadziuszko R, Krebs MG, De Braud F, Siena S, Drilon A, Doebele RC, Patel MR, Cho BC, Liu SV, Ahn MJ, Chiu CH, Farago AF, Lin CC, Karapetis CS, Li YC, Day BM, Chen D, Wilson TR, Barlesi F. Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Apr 10;39(11):1253-1263. doi: 10.1200/JCO.20.03025. Epub 2021 Mar 1.
- pmid
- 33646820
- type
- DERIVED
- citation
- Drilon A, Siena S, Dziadziuszko R, Barlesi F, Krebs MG, Shaw AT, de Braud F, Rolfo C, Ahn MJ, Wolf J, Seto T, Cho BC, Patel MR, Chiu CH, John T, Goto K, Karapetis CS, Arkenau HT, Kim SW, Ohe Y, Li YC, Chae YK, Chung CH, Otterson GA, Murakami H, Lin CC, Tan DSW, Prenen H, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Doebele RC; trial investigators. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):261-270. doi: 10.1016/S1470-2045(19)30690-4. Epub 2019 Dec 11.
- pmid
- 31838015
- type
- DERIVED
- citation
- Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11.
- pmid
- 31838007
- type
- DERIVED
- citation
- Sigal D, Tartar M, Xavier M, Bao F, Foley P, Luo D, Christiansen J, Hornby Z, Maneval EC, Multani P. Activity of Entrectinib in a Patient With the First Reported NTRK Fusion in Neuroendocrine Cancer. J Natl Compr Canc Netw. 2017 Nov;15(11):1317-1322. doi: 10.6004/jnccn.2017.7029.
- pmid
- 29118225
- type
- DERIVED
Source notices and limitations
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Preserved source evidence · Independent clinical review pending · Not medical advice