{"entity":{"id":"nct02568267","kind":"trial","name":"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 Rearrangeme","aka":["STARTRK-2"],"tldr":"A phase 2 trial of Entrectinib in colorectal cancer and melanoma, run by Hoffmann-La Roche, active and no longer recruiting.","summary":"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) is a phase 2 interventional study registered as NCT02568267 by Hoffmann-La Roche, with 534 participants enrolled, started 2015-11-19 and due to reach its primary completion in 2027-06-30. Interventions recorded: Entrectinib. Conditions listed: Breast Cancer, Cholangiocarcinoma, Colorectal Cancer, Head and Neck Neoplasms. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT02568267","url":"https://clinicaltrials.gov/study/NCT02568267"},{"label":"Entrectinib integrated analysis (Lancet Oncology 2020)","url":"https://doi.org/10.1016/S1470-2045(19)30691-6"},{"label":"NICE TA643: entrectinib for treating ROS1-positive advanced non-small-cell lung cancer","url":"https://www.nice.org.uk/guidance/ta643"}],"tags":["ctgov-ingest"],"related":[],"cancers":["colorectal","melanoma","nsclc","sclc","ovarian","ros1-positive-nsclc","ntrk-fusion-nsclc","alk-positive-nsclc"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["entrectinib"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":["profile-1001-ros1","nct03093116"],"people":[],"bottlenecks":[],"keyPapers":["paper-drilon-entrectinib-ros1-lancet-oncol-2020"],"journals":[],"dependsOn":[],"notes":["The integrated analysis of ALKA-372-001, STARTRK-1 and STARTRK-2 is the basis of the entrectinib approvals. It pooled patients aged 18 or over with metastatic or locally advanced NTRK1, NTRK2 or NTRK3 fusion-positive solid tumours who received at least 600 mg of entrectinib daily and had had no previous TRK inhibitor, with objective response and duration of response by blinded independent central review as the primary endpoints (Lancet Oncology 2020). Entrectinib crosses the blood-brain barrier, which is why it is preferred to crizotinib in ROS1-positive lung cancer with brain metastases. NICE TA643 (12 August 2020) recommends entrectinib for ROS1-positive advanced non-small-cell lung cancer."],"nct":"NCT02568267","phase":"2","setting":"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","sponsor":"Hoffmann-La Roche","started":"2015-11-19","startedType":"actual","enrolled":534,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct02568267/","neighbours":{"cancer":[{"id":"alk-positive-nsclc","kind":"cancer","name":"ALK-positive non-small-cell lung cancer","route":"/cancers/alk-positive-nsclc/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"ntrk-fusion-nsclc","kind":"cancer","name":"NTRK fusion-positive non-small-cell lung cancer","route":"/cancers/ntrk-fusion-nsclc/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"ros1-positive-nsclc","kind":"cancer","name":"ROS1-positive non-small-cell lung cancer","route":"/cancers/ros1-positive-nsclc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"entrectinib","kind":"drug","name":"Entrectinib","route":"/drugs/entrectinib/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"trial":[{"id":"nct03093116","kind":"trial","name":"A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements","route":"/trials/nct03093116/"},{"id":"profile-1001-ros1","kind":"trial","name":"PROFILE 1001 ROS1 expansion cohort","route":"/trials/profile-1001-ros1/"}],"paper":[{"id":"paper-drilon-entrectinib-ros1-lancet-oncol-2020","kind":"paper","name":"Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three trials","route":"/key-papers/paper-drilon-entrectinib-ros1-lancet-oncol-2020/"}]}}