TriangleNCT02637687 · CITED IN SOURCE DOCUMENTS
A Study to Test the Safety and Efficacy of the Drug Larotrectinib for the Treatment of Tumors With NTRK-fusion in Children
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1, PHASE2
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2025-06-22
The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb.
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: * Phase 1 (Closed): * Dose escalation: Birth through 21 years of age at C1D1 with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies and for which no standard or available systemic curative therapy exists; OR Infants from birth and older with a diagnosis of malignancy and with a documented NTRK fusion that has progressed or was nonresponsive to available therapies, and for which no standard or available curative therapy exists; OR Patients with locally advanced infantile fibrosarcoma who would require, in the opinion of the investigator, disfiguring surgery or limb amputation to achieve a complete surgical resection. Phase I dose escalation cohorts are closed to enrollment. * Dose expansion: In addition to the above stated inclusion criteria, patients must have a malignancy with a documented NTRK gene fusion with the exception of patients with infantile fibrosarcoma, congenital mesoblastic nephroma or secretory breast cancer. Patients with infantile fibrosarcoma, congenital mesoblastic nephroma or secretory breast cancer may enroll into this cohort with documentation of an ETV6 rearrangement by FISH or RT-PCR or a documented NTRK fusion by next generation sequencing. * Phase 2: \-- Infants from birth and older at C1D1 with a locally advanced or metastatic infantile fibrosarcoma, patients with locally advanced infantile fibrosarcoma who would require, in the opinion of the investigator, disfiguring surgery or limb amputation to achieve a complete surgical resection; OR Birth through 21 years of age at C1D1 with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies and for which no standard or available systemic curative therapy exists with a documented NTRK gene fusion (or in the case of infantile fibrosarcoma, congenital mesoblastic nephroma or secretory breast cancer with documented ETV6 rearrangement (or NTRK3 rearrangement after discussion with the sponsor) by FISH or RT-PCR. Patients with NTRK-fusion positive benign tumors are also eligible; OR Potential patients older than 21 years of age with a tumor diagnosis with histology typical of a pediatric patient and an NTRK fusion may be considered for enrollment following discussion between the local site Investigator and the Sponsor. * Patients with primary CNS tumors or cerebral metastasis * Karnofsky (those 16 years and older) or Lansky (those younger than 16 years) performance score of at least 50. * Adequate hematologic function * Adequate hepatic and renal function Exclusion Criteria: * Major surgery within 14 days (2 weeks) prior to C1D1 * Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to C1D1, ongoing cardiomyopathy; current prolonged QTc interval \> 480 milliseconds * Active uncontrolled systemic bacterial, viral, or fungal infection * Current treatment with a strong CYP3A4 inhibitor or inducer. Enzyme-inducing anti-epileptic drugs (EIAEDs) and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed. * Phase 2 only: * Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK, including entrectinib, crizotinib and lestaurtinib. Patients who received a TRK inhibitor for less than 28 days of treatment and discontinued because of intolerance remain eligible.
- healthy Volunteers
- false
- maximum Age
- 21 Years
- sex
- ALL
- std Ages
- CHILD
- ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients will receive the different levels of dose on Day 1 (BID in accordance with the cohort assignment). Each cycle will consist of 28 days of continuous dosing. Individual patients will continue daily larotrectinib dosing until PD, unacceptable toxicity, or other reason for treatment discontinuation. (arm closed)
- intervention Names
- Drug: Larotrectinib (Vitrakvi, BAY2757556)
- label
- Phase 1 dose escalation
- type
- EXPERIMENTAL
- description
- Patients who are enrolled in the expansion cohort, following the formal dose escalation phase of the study. Distinct from the Phase 1 dose escalation cohort, the Phase 1 expansion cohort will enroll pediatric patients with advanced solid or primary CNS tumors with a documented NTRK gene fusion, or in the case of IFS, CMN or SBC with documented ETV6 rearrangement by FISH or RT-PCR or a documented NTRK fusion by NGS. This expansion cohort will follow the same schedule of assessments as the dose escalation cohorts. (arm closed)
- intervention Names
- Drug: Larotrectinib (Vitrakvi, BAY2757556)
- label
- Phase 1 dose expansion
- type
- EXPERIMENTAL
- description
- Patients will receive larotrectinib dose on Day 1 (BID in accordance with the cohort assignment) at the recommended Phase 2 dose as determined in the Phase 1 portion of this study. Each cycle will consist of 28 days of continuous dosing. Individual patients will continue daily larotrectinib dosing until PD, unacceptable toxicity, or other reason for treatment discontinuation. (arm closed)
- intervention Names
- Drug: Larotrectinib (Vitrakvi, BAY2757556)
- label
- Phase 2: Patients with tumors bearing NTRK fusions (IFS)_Cohort 1
- type
- EXPERIMENTAL
- description
- Patients will receive larotrectinib dose on Day 1 (BID in accordance with the cohort assignment) at the recommended Phase 2 dose as determined in the Phase 1 portion of this study. Each cycle will consist of 28 days of continuous dosing. Individual patients will continue daily larotrectinib dosing until PD, unacceptable toxicity, or other reason for treatment discontinuation. (arm closed)
- intervention Names
- Drug: Larotrectinib (Vitrakvi, BAY2757556)
- label
- Phase 2: Other extra-cranial solid tumors_Cohort 2
- type
- EXPERIMENTAL
- description
- Patients will receive larotrectinib dose on Day 1 (BID in accordance with the cohort assignment) at the recommended Phase 2 dose as determined in the Phase 1 portion of this study. Each cycle will consist of 28 days of continuous dosing. Individual patients will continue daily larotrectinib dosing until PD, unacceptable toxicity, or other reason for treatment discontinuation.
- intervention Names
- Drug: Larotrectinib (Vitrakvi, BAY2757556)
- label
- Phase 2: Primary CNS tumors_Cohort 3
- type
- EXPERIMENTAL
- description
- Patients will receive larotrectinib dose on Day 1 (BID in accordance with the cohort assignment) at the recommended Phase 2 dose as determined in the Phase 1 portion of this study. Each cycle will consist of 28 days of continuous dosing. Individual patients will continue daily larotrectinib dosing until PD, unacceptable toxicity, or other reason for treatment discontinuation. Patients in this group will undergo bone health assessments in addition to all other efficacy and safety assessments.
- intervention Names
- Drug: Larotrectinib (Vitrakvi, BAY2757556)
- label
- Phase 2: Bone health assessment_sub-cohort
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Phase 1 dose escalation
- Phase 1 dose expansion
- Phase 2: Bone health assessment_sub-cohort
- Phase 2: Other extra-cranial solid tumors_Cohort 2
- Phase 2: Patients with tumors bearing NTRK fusions (IFS)_Cohort 1
- Phase 2: Primary CNS tumors_Cohort 3
- description
- BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.
- name
- Larotrectinib (Vitrakvi, BAY2757556)
- other Names
- LOXO-101
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 154
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- DLT: Dose-limiting toxicity. NCI-CTCAE: National Cancer Institute-Common Terminology Criteria for Adverse Events.
- measure
- Phase 1: Number of participants in an assigned dose cohort with treatment emergent adverse events (TEAEs) by grade assessed by NCI-CTCAE v 4.03 who experience a DLT
- time Frame
- From Day 1 to Day 28 of Cycle 1 (1 Cycle=28 days)
- measure
- Phase 1: Number of participants with TEAEs
- time Frame
- From first dose of larotrectinib up to 93 months
- measure
- Phase 1: Severity of TEAEs
- time Frame
- From first dose of larotrectinib up to 93 months
- description
- Proportion of participants with a best overall response of complete response (CR) or partial response (PR) as determined by an independent radiology review committee (IRRC) based on Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, Response Assessment in Neuro Oncology (RANO) or International Neuroblastoma Response Criteria (INRC) as appropriate to tumor type who express NTRK gene fusions.
- measure
- Phase 2: Overall response rate (ORR) by IRRC
- time Frame
- From first dose of Larotrectinib to disease progression or subsequent therapy or surgical intervention or death, up to 76 months
- secondary Outcomes
- measure
- Phase 1: Maximum concentration of larotrectinib in plasma (Cmax)
- time Frame
- Cohort 1 and 2: Cycle 1 Day 1 (C1D1) at 1 and 4 hours post-dose and C2D1 at pre-dose, and at 1 and 4 hours post-dose; Cohort 3 and Dose Expansion Cohort: C1D1 at 1 and 4 hours post-dose and C4D1 at pre-dose, 1 and 4 hours post-dose
- measure
- Phase 1: Area under the concentration versus time curve from time 0 to t (AUC0-t) of larotrectinib in plasma
- time Frame
- Cohort 1 and 2: C1D1 at 1 and 4 hours post-dose and C2D1 at pre-dose, and at 1 and 4 hours post-dose; Cohort 3 and Dose Expansion Cohort: C1D1 at 1 and 4 hours post-dose and C4D1 at pre-dose, 1 and 4 hours post-dose
- measure
- Phase 1: Oral clearance (CL/F)
- time Frame
- Cohort 1 and 2: C1D1 at 1 and 4 hours post-dose and C2D1 at pre-dose, and at 1 and 4 hours post-dose; Cohort 3 and Dose Expansion Cohort: C1D1 at 1 and 4 hours post-dose and C4D1 at pre-dose, 1 and 4 hours post-dos
- measure
- Phase 1: Cerebral spinal fluid/plasma ratio of larotrectinib
- time Frame
- C1D1 in conjunction with the post-dose 1-hour PK sample
- measure
- Phase 1: Maximum tolerated dose (MTD)
- time Frame
- From C1D1 to C1D28 of treatment of each participant in each of the assigned dose cohort, up to 16 months
- measure
- Phase 1: Recommended dose for Phase 2
- time Frame
- From the date a participants from assigned Cohort was administered the first dose to the date of the last dose for the last patient from the dose escalation phase, up to 16 months
- description
- Proportion of participants with best overall response (BOR) of CR and PR; PFS, CBR and maximum change in tumor burden as assessed based on RECIST 1.1, INRC or RANO as appropriate for tumor type by IRRC.
- measure
- Phase 1: Overall Response Rate (ORR)
- time Frame
- From first dose of Larotrectinib to disease progression or subsequent therapy or surgical intervention or death (due to any cause), up to 93 months
- description
- Wong-Baker Faces Scale giving a pain scale between 0 (no hurt) to 10 (hurts worst).
- measure
- Phase 1: Mean change from baseline in Pain scores as assessed by the Wong-Baker Faces scale
- time Frame
- Baseline and D1 of every cycle (1 Cycle=28 days), up to 93 months
- description
- The health-related quality of life (HRQoL) is assessed with the Pediatrics Quality of Life - Core Module (PedsQL-Core) questionnaire that consists of various age-related items regarding physical, emotional, social and school functioning and gives an overall score between 0 (highest HRQoL) and 144 (lowest HRQoL).
- measure
- Phase 1: Mean change in Health-related quality of life scores by PedsQL-Core
- time Frame
- Baseline and D1 of every cycle (1 Cycle=28 days), Up to 93 months
- description
- Participants with best overall response (BOR) of either CR or PR determined by Investigator's or IRC's response assessment based on RANO, INRC and RECIST 1.1 as appropriate for tumor type
- measure
- Phase 2: Best overall response (BOR)
- time Frame
- From first dose of Larotrectinib to disease progression or subsequent therapy or surgical intervention or death (due to any cause), up to 76 months
- description
- DOR determined by 1) an independent radiology review committee and 2) the treating Investigator.
- measure
- Phase 2: Duration of response (DOR)
- time Frame
- From start of first objective response of confirmed CR or PR to progression or death (due to any cause), up to 76 months
- measure
- Phase 2: Proportion of patients with any tumor regression (i.e., any decrease from baseline of the longest diameters of target lesions) as a best response
- time Frame
- From first dose of Larotrectinib, up to 76 months
Full study description
- brief Summary
- The study is being done to test the safety of a cancer drug called larotrectinib in children. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer. The first study part (Phase 1) is done to determine what dose level of larotrectinib is safe for children, how the drug is absorbed and changed by their bodies and how well the cancer responds to the drug. The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with larotrectininb.
Source references
- references
- citation
- Mascarenhas L, Ollis C, Singh Y, Menachery L, Burcoveanu DI, De La Cuesta E, van Tilburg CM, Laetsch TW. Cancer control after pausing treatment with larotrectinib in responding children with sarcoma and a TRK fusion: a plain language summary. Future Oncol. 2026 Aug 19:1-10. doi: 10.1080/14796694.2026.2711519. Online ahead of print.
- pmid
- 42614029
- type
- DERIVED
- citation
- Ajani JA, D'Amico TA, Bentrem DJ, Corvera CU, Das P, Enzinger PC, Enzler T, Gerdes H, Gibson MK, Grierson P, Gupta G, Hofstetter WL, Ilson DH, Jalal S, Kim S, Kleinberg LR, Klempner S, Lacy J, Lee B, Licciardi F, Lloyd S, Ly QP, Matsukuma K, McNamara M, Merkow RP, Miller AM, Mukherjee S, Mulcahy MF, Perry KA, Pimiento JM, Reddi DM, Reznik S, Roses RE, Strong VE, Su S, Uboha N, Wainberg ZA, Willett CG, Woo Y, Yoon HH, McMillian NR, Stein M. Gastric Cancer, Version 2.2025, NCCN Clinical Practice Guidelines In Oncology. J Natl Compr Canc Netw. 2025 May;23(5):169-191. doi: 10.6004/jnccn.2025.0022.
- pmid
- 40341199
- type
- DERIVED
- citation
- Brose MS, Westphalen CB, Pan X, Bernard-Gauthier V, Kurtinecz M, Guo H, Aris V, Brett NR, Majdi A, Subbiah V, Pennell NA, Kehl KL, Drilon A. Larotrectinib Compared With Real-World Non-Tropomyosin Receptor Kinase Inhibitor Therapies in Patients With Tropomyosin Receptor Kinase Fusion Cancer. JCO Precis Oncol. 2025 Apr;9:e2400500. doi: 10.1200/PO-24-00500. Epub 2025 Apr 23.
- pmid
- 40267388
- type
- DERIVED
- citation
- Mascarenhas L, DuBois SG, Albert CM, Bielack S, Orbach D, Federman N, Geoerger B, Nagasubramanian R, Zhang Y, Chisholm J, Gallego Melcon S, Goto H, Morgenstern DA, Owens C, Pappo AS, Perreault S, Schulte JH, Shukla N, Zwaan CM, Neu N, Bernard-Gauthier V, De La Cuesta E, van Tilburg CM, Laetsch TW. Elective Discontinuation of Larotrectinib in Pediatric Patients With TRK Fusion Sarcomas and Related Mesenchymal Tumors. J Clin Oncol. 2025 Apr;43(10):1180-1187. doi: 10.1200/JCO.24.00848. Epub 2025 Jan 27.
- pmid
- 39869835
- type
- DERIVED
- citation
- Nahon-Esteve S, Orbach D, Le Loarer F, Hofman P, Lassalle S. Fibroblastic orbital tumour with NTRK1 fusion transcript: when TRK inhibitors rescue surgery. Can J Ophthalmol. 2024 Aug;59(4):e407-e409. doi: 10.1016/j.jcjo.2023.11.008. Epub 2023 Dec 11. No abstract available.
- pmid
- 38096907
- type
- DERIVED
- citation
- Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7.
- pmid
- 37934000
- type
- DERIVED
- citation
- Kummar S, Shen L, Hong DS, McDermott R, Keedy VL, Casanova M, Demetri GD, Dowlati A, Melcon SG, Lassen UN, Leyvraz S, Liu T, Moreno V, Patel J, Patil T, Mallick AB, Sousa N, Tahara M, Ziegler DS, Norenberg R, Arvis P, Brega N, Drilon A, Tan DSW. Larotrectinib efficacy and safety in adult patients with tropomyosin receptor kinase fusion sarcomas. Cancer. 2023 Dec 1;129(23):3772-3782. doi: 10.1002/cncr.35036. Epub 2023 Sep 28.
- pmid
- 37769113
- type
- DERIVED
- citation
- Bokemeyer C, Paracha N, Lassen U, Italiano A, Sullivan SD, Marian M, Brega N, Garcia-Foncillas J. Survival Outcomes of Patients With Tropomyosin Receptor Kinase Fusion-Positive Cancer Receiving Larotrectinib Versus Standard of Care: A Matching-Adjusted Indirect Comparison Using Real-World Data. JCO Precis Oncol. 2023 Jan;7:e2200436. doi: 10.1200/PO.22.00436.
- pmid
- 36689698
- type
- DERIVED
- citation
- Rudzinski ER, Drilon A, Moore A, Spinosa S, Willi M, Laetsch TW. Testing methods to diagnose TRK fusion cancer - a plain language summary and patient perspective. Future Oncol. 2022 Dec;18(38):4141-4151. doi: 10.2217/fon-2022-0863. Epub 2023 Jan 6.
- pmid
- 36606522
- type
- DERIVED
- citation
- Doz F, van Tilburg CM, Geoerger B, Hojgaard M, Ora I, Boni V, Capra M, Chisholm J, Chung HC, DuBois SG, Gallego-Melcon S, Gerber NU, Goto H, Grilley-Olson JE, Hansford JR, Hong DS, Italiano A, Kang HJ, Nysom K, Thorwarth A, Stefanowicz J, Tahara M, Ziegler DS, Gavrilovic IT, Norenberg R, Dima L, De La Cuesta E, Laetsch TW, Drilon A, Perreault S. Efficacy and safety of larotrectinib in TRK fusion-positive primary central nervous system tumors. Neuro Oncol. 2022 Jun 1;24(6):997-1007. doi: 10.1093/neuonc/noab274.
- pmid
- 34850167
- type
- DERIVED
- citation
- Bebb DG, Banerji S, Blais N, Desmeules P, Gill S, Grin A, Feilotter H, Hansen AR, Hyrcza M, Krzyzanowska M, Melosky B, Noujaim J, Purgina B, Ruether D, Simmons CE, Soulieres D, Torlakovic EE, Tsao MS. Canadian Consensus for Biomarker Testing and Treatment of TRK Fusion Cancer in Adults. Curr Oncol. 2021 Jan 15;28(1):523-548. doi: 10.3390/curroncol28010053.
- pmid
- 33467570
- type
- DERIVED
- citation
- Perreault S, Chami R, Deyell RJ, El Demellawy D, Ellezam B, Jabado N, Morgenstern DA, Narendran A, Sorensen PHB, Wasserman JD, Yip S. Canadian Consensus for Biomarker Testing and Treatment of TRK Fusion Cancer in Pediatric Patients. Curr Oncol. 2021 Jan 9;28(1):346-366. doi: 10.3390/curroncol28010038.
- pmid
- 33435412
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-2a33086ae50cfe873d8a
- requested nct id
- NCT02637687
- primary nct id
- NCT02637687
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source file sha256
- 68c1706258e98d38c9ed48fd0c71432d06d320b05c8885ceb5fa728eadea7590
- payload sha256
- 4a30ab81f2c565a0a4805c74afcc36e9cc6179f40dd3dfaa90a83d767885f124
- payload
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-2a33086ae50cfe873d8a
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT02637687
- occurrences
- context exact
- rom three multicenter, open-label, single-arm clinical trials: <a href="/clinicaltrials/NCT02122913">LOXO-TRK-14001</a> (NCT02122913), <a href="/clinicaltrials/NCT02637687">SCOUT</a> (NCT02637687), and <a href="/clinicaltrials/NCT02576431">NAVIGATE</a> (NCT02576431).[<a href="#cit/section_4.3">3</a>,<a href="#cit/section_4.4">4</
- end
- 41653
- exact text
- NCT02637687
- start
- 41642
- context exact
- pen-label, single-arm clinical trials: <a href="/clinicaltrials/NCT02122913">LOXO-TRK-14001</a> (NCT02122913), <a href="/clinicaltrials/NCT02637687">SCOUT</a> (NCT02637687), and <a href="/clinicaltrials/NCT02576431">NAVIGATE</a> (NCT02576431).[<a href="#cit/section_4.3">3</a>,<a href="#cit/section_4.4">4</a>][<a href="/Common/Pop
- end
- 41677
- exact text
- NCT02637687
- start
- 41666
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/nci/raw/673b6b58fe51113964.html
- source file sha256
- 68c1706258e98d38c9ed48fd0c71432d06d320b05c8885ceb5fa728eadea7590
- source json pointer
- Source null
- source kind
- nci_explicit_reference_or_link
- source record id
- Source null
- source retrieved at
- 2026-09-09T23:21:27.710469+00:00
- source string basis
- UTF-8_text_with_universal_newline_translation
- source string sha256
- dd1d1d1ad91100ad4c1f7e9f55ba1a72466b1757ab229115c118a2a0940b3724
- source title
- Agnostic Cancer Therapies (PDQ®)–Health Professional Version
- source update dates
- context
- Updated: February 12, 2025
- datetime
- 2025-02-12T12:00:00Z
- display
- February 12, 2025
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-9e7747bfa57bd0db7a3a
- requested nct id
- NCT02637687
- primary nct id
- NCT02637687
- source kind
- fda_spl_label
- source record id
- 0e3ba6e7-af8d-4840-9409-a537a09e1263
- source file sha256
- 0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
- payload sha256
- b995eb95a6771982ca966ee8fe326eeee5e12a42d80a146ccf5e1a7eafd90835
- payload
- application numbers
- NDA210861
- NDA211710
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-9e7747bfa57bd0db7a3a
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT02637687
- occurrences
- context exact
- c solid tumors with a NTRK gene fusion enrolled in one of three multicenter, open-label, single-arm clinical trials: Study LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687), and NAVIGATE (NCT02576431). All patients were required to have progressed following systemic therapy for their disease, if available, or would have required
- end
- 292
- exact text
- NCT02637687
- start
- 281
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00000.json
- source file sha256
- 0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
- source json pointer
- /results/42/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 0e3ba6e7-af8d-4840-9409-a537a09e1263
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 4f028adde96c1dc045a5281ccf403d3d7c478ae7219cdaf55133bd1b5c5e52e3
- spl effective time
- 20260522
- spl set id
- 0c8ca614-58b2-4aa4-83d3-0387a8f782fd
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-9ee863908d671240cd99
- requested nct id
- NCT02637687
- primary nct id
- NCT02637687
- source kind
- fda_spl_label
- source record id
- 5b9e7961-f843-49d8-94b5-a2ce2c9efa46
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- payload sha256
- 48ac278b3bfdae9a7dd09e0cd0f7bc4b3516cb3c59e1740863376c28d57448d8
- payload
- application numbers
- NDA210861
- NDA211710
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-9ee863908d671240cd99
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT02637687
- occurrences
- context exact
- c solid tumors with a NTRK gene fusion enrolled in one of three multicenter, open-label, single-arm clinical trials: Study LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687), and NAVIGATE (NCT02576431). All patients were required to have progressed following systemic therapy for their disease, if available, or would have required
- end
- 292
- exact text
- NCT02637687
- start
- 281
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00300.json
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- source json pointer
- /results/90/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 5b9e7961-f843-49d8-94b5-a2ce2c9efa46
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- ed6532de27b99806967367f5be0d36942147b37c61bae057b6227e1d7bddc580
- spl effective time
- 20181205
- spl set id
- 9525f887-a055-4e33-8e92-898d42828cd1
Preserved source evidence · Independent clinical review pending · Not medical advice