{"entity":{"id":"ipatasertib","kind":"drug","name":"Ipatasertib","aka":[],"tldr":"Ipatasertib is an experimental small-molecule drug from Hoffmann-La Roche in phase 3 trials for HR-positive / HER2-negative breast cancer and ovarian cancer, aimed at AKT.","summary":"Ipatasertib (GDC-0068, RO5532961, RG7440) is a small-molecule drug developed by Hoffmann-La Roche. Its target is AKT (the sponsor names AKT). ClinicalTrials.gov describes the intervention as: For participants 12-17 years of age, ipatasertib will be administered at the starting dose of 200 mg for participants \\< 35 kg, 300 mg for participants ≥35 and \\< 45 kg, 400 mg for those ≥ 45 kg orally QD, beginning of Cycle 1, on Days 1-21. It is the investigational product in 5 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including the phase 3 study NCT05862285 (A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study), in HR-positive / HER2-negative breast cancer and ovarian cancer. The largest, NCT03424005, plans to enrol 1132 participants with primary completion expected 2030-09-30. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of Ipatasertib","url":"https://clinicaltrials.gov/search?intr=GDC-0068"},{"label":"IPATunity130 cohort A (Clinical Cancer Research 2024)","url":"https://doi.org/10.1158/1078-0432.CCR-24-0465"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","ovarian","tnbc","tnbc-metastatic","tnbc-early"],"sections":[],"technologies":[],"targets":["akt"],"drugs":[],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05862285","nct04931342","ipatunity130","barbican"],"people":[],"bottlenecks":[],"keyPapers":["paper-kim-lotus-ipatasertib-tnbc-lancet-oncol-2017"],"journals":[],"dependsOn":[],"notes":["Triple-negative breast cancer: IPATunity130 cohort A (255 patients with PIK3CA, AKT1 or PTEN-altered advanced disease, first-line paclitaxel with or without ipatasertib) showed no progression-free survival difference (7.4 versus 6.1 months, hazard ratio 1.02) and no overall survival difference (24.4 versus 24.9 months), failing to confirm the phase 2 LOTUS signal; grade 3 or worse diarrhoea was 9 versus 2 percent. The UK BARBICAN phase 2 (146 patients, Barts) tests its contribution to neoadjuvant chemotherapy with atezolizumab."],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"code":"GDC-0068, RO5532961, RG7440","modality":"small molecule","mechanism":"Small-molecule drug directed at AKT, as stated in the ClinicalTrials.gov intervention record; the detailed mechanism is not stated.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ipatasertib/","neighbours":{"cancer":[{"id":"tnbc-early","kind":"cancer","name":"Early triple-negative breast cancer","route":"/cancers/tnbc-early/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"hr-positive-metastatic-post-cdk46","kind":"cancer","name":"HR-positive metastatic breast cancer after CDK4/6 inhibitors","route":"/cancers/hr-positive-metastatic-post-cdk46/"},{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"target":[{"id":"akt","kind":"target","name":"AKT","route":"/targets/akt/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"trial":[{"id":"nct05862285","kind":"trial","name":"A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study","route":"/trials/nct05862285/"},{"id":"nct04931342","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors","route":"/trials/nct04931342/"},{"id":"nct04802759","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer","route":"/trials/nct04802759/"},{"id":"nct03424005","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer","route":"/trials/nct03424005/"},{"id":"barbican","kind":"trial","name":"BARBICAN","route":"/trials/barbican/"},{"id":"cupisco","kind":"trial","name":"CUPISCO","route":"/trials/cupisco/"},{"id":"ipatunity130","kind":"trial","name":"IPATunity130","route":"/trials/ipatunity130/"},{"id":"lotus","kind":"trial","name":"LOTUS","route":"/trials/lotus/"},{"id":"nct04589845","kind":"trial","name":"Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study","route":"/trials/nct04589845/"}],"paper":[{"id":"paper-kim-lotus-ipatasertib-tnbc-lancet-oncol-2017","kind":"paper","name":"Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial","route":"/key-papers/paper-kim-lotus-ipatasertib-tnbc-lancet-oncol-2017/"},{"id":"paper-ipatential150-ipatasertib-abiraterone-pten-lancet-2021","kind":"paper","name":"IPATential150: ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer","route":"/key-papers/paper-ipatential150-ipatasertib-abiraterone-pten-lancet-2021/"}]}}