Drugs / Ipatasertib
Trials 54
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 117 trials | ||||||
| Phase 1 | NCT05172245 | Sep 2022 → Jul 2027 expected | cancer of unknown primary site, hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, maxillary sinus squamous cell carcinoma +2 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT05276973 | Sep 2022 → Jan 2025 overdue | fallopian tube endometrioid adenocarcinoma, fallopian tube serous adenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian serous cystadenocarcinoma +1 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04341259 | Nov 2020 → Apr 2023 | cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT04404140 | Jul 2020 → Oct 2022 | castration-resistant prostate carcinoma | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04253561 | Feb 2020 → Dec 2021 | breast cancer | SOLTI Breast Cancer Research Group | Completed | No outcome recorded |
| Phase 1 | NCT04060862 | Nov 2019 → Aug 2023 | breast cancer | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT03840200 | Jun 2019 → Dec 2021 | breast cancer, ovarian cancer, prostate cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03959891 | May 2019 → Dec 2022 overdue | breast cancer | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03800836 | Feb 2018 → Mar 2022 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03341884 | Nov 2017 → Jun 2018 | liver disorder | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03222310 | Jul → Sep 2017 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02536391 | Oct → Nov 2015 | cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02390492 | Mar → Apr 2015 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02063581 | Feb → Mar 2014 | — | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01562275 | Apr 2012 → Jan 2015 | neoplasm | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01362374 | Jul 2011 → Oct 2020 | neoplasm | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01090960 | Mar 2010 → Feb 2015 | solid adenocarcinoma with mucin production | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/210 trials · 1 missed | ||||||
| Phase 1/2 | NCT05538897 | Mar 2023 → Jan 2027 expected | endometrial endometrioid adenocarcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04486352 | Oct 2021 → Oct 2026 expected | endometrial cancer | Alliance Foundation Trials, LLC. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04737109 | Jul 2021 → Aug 2022 | castration-resistant prostate carcinoma | David VanderWeele | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04802759 | Jun 2021 → May 2029 expected | estrogen-receptor positive breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03853707 | Mar 2019 → Jan 2023 | female breast carcinoma, triple-negative breast carcinoma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT03673787 | Aug 2018 → Mar 2026 overdue | glioblastoma, metastatic prostate carcinoma | Institute of Cancer Research, United Kingdom | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03424005 | Mar 2018 → Sep 2030 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03337698 | Dec 2017 → Oct 2025 | non-small cell lung carcinoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1/2 | NCT03280563 | Dec 2017 → Sep 2024 | breast neoplasm | Hoffmann-La Roche | Completed | Missed primary |
| Phase 1/2 | NCT02430363 | Mar 2013 → Jan 2016 | glioblastoma | Medical Research Council | Unknown | No outcome recorded |
| Phase 222 trials · 2 met primary · 2 missed | ||||||
| Phase 2 | NCT05554380 | Sep 2023 → Aug 2026 | high grade malignant neoplasm, metastatic malignant neoplasm | National Cancer Institute (NCI) | Suspended | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05332561 | Jun 2023 → Mar 2030 expected | female breast carcinoma | German Cancer Research Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05564377 | Apr 2023 → Jul 2030 expected | Her2-receptor negative breast cancer, endometrial carcinoma, fallopian tube carcinoma, female breast carcinoma +3 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT04920708 | Dec 2022 → Jun 2027 expected | estrogen-receptor positive breast cancer | Royal Marsden NHS Foundation Trust | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05172258 | Jul 2022 → Jun 2027 expected | hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, oral cavity squamous cell carcinoma, oropharynx squamous cell carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04551521 | Oct 2021 → Dec 2024 | cancer | German Cancer Research Center | Completed | No outcome recorded |
| Phase 2 | NCT04931342 | Oct 2021 → Feb 2028 expected | ovarian cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04467801 | Sep 2021 → Aug 2024 | non-small cell lung carcinoma | Jun Zhang, MD, PhD | Unknown | No outcome recorded |
| Phase 2 | NCT04739202 | Mar 2021 → Jun 2026 | gastric adenocarcinoma | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase 2 | NCT04589845 | Jan 2021 → Sep 2032 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04632992 | Jan 2021 → Dec 2023 | cancer of unknown primary site | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04464174 | Oct 2020 → Nov 2023 | triple-negative breast carcinoma | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | Met primary |
| Phase 2 | NCT06400251 | Aug 2019 → Jun 2023 overdue | adult lymphoma, plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05498896 | Dec 2018 → Aug 2026 overdue | triple-negative breast carcinoma | Queen Mary University of London | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03385655 | Aug 2018 → Oct 2024 overdue | prostate cancer | Canadian Cancer Trials Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03498521 | Jul 2018 → Feb 2023 | cancer of unknown primary site | Hoffmann-La Roche | Completed | Met primary |
| Phase 2 | NCT03395899 | Dec 2017 → Aug 2023 | estrogen-receptor positive breast cancer | Queen Mary University of London | Completed | No outcome recorded |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2027 expected | breast carcinoma, carcinoma of esophagus, cervical carcinoma, colon carcinoma +17 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02301988 | Feb 2015 → Aug 2017 | breast cancer | Genentech, Inc. | Completed | Missed primary |
| Phase 2 | NCT02162719 | Aug 2014 → Jun 2016 | breast neoplasm | Genentech, Inc. | Completed | Mixed |
| Phase 2 | NCT01896531 | Aug 2013 → Jun 2015 | gastric cancer | Genentech, Inc. | Completed | Missed primary |
| Phase 35 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT05862285 | Jun 2023 → Mar 2033 expected | cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT04650581 | Jan 2021 → May 2025 overdue | breast cancer | Canadian Cancer Trials Group | Active not recruiting | Met primary |
| Phase 3 | NCT04177108 | Nov 2019 → Feb 2023 | triple-negative breast carcinoma | Hoffmann-La Roche | Completed | Mixed |
| Phase 3 | NCT03337724 | Jan 2018 → Jan 2023 | breast cancer | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT03072238 | Jun 2017 → Mar 2020 | metastatic prostate carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT04561817 Comparator | Oct 2020 → Oct 2022 | ovarian cancer | Icahn School of Medicine at Mount Sinai | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2020-06-19 | Hoffmann-La Roche | Results Roche’s IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone met one of its co-primary endpoints roche.com ↗
In this patient group, ipatasertib in combination with abiraterone and prednisone/prednisolone provided a statistically significant reduction in the risk of disease worsening or death, compared to current standard of care (abiraterone and prednisone/prednisolone) plus placebo. |
| 2020-06-19 | Chugai Pharmaceutical | Results Phase III IPATential150 Study Evaluating Ipatasertib in Combination with Abiraterone and Prednisone/Prednisolone in Patients with Metastatic Castration-Resistant Prostate Cancer Meets One of Its Co-Primary Endpoint chugai-pharm.co.jp ↗ |
| 2020-06-18 | Genentech, Inc. | Results Genentech’s IPATential150 Study Evaluating Ipatasertib in Combination With Abiraterone and Prednisone/Prednisolone Met One of Its Co-Primary Endpoints gene.com ↗
In this patient group, ipatasertib in combination with abiraterone and prednisone/prednisolone provided a statistically significant reduction in the risk of disease worsening or death, compared to current standard of care (abiraterone and prednisone/prednisolone) plus placebo. |
| 2020-05-06 | Genentech, Inc. | Results New Data at the ASCO20 Virtual Scientific Program Reflects Genentech’s Commitment to Accelerating Progress in Cancer Care gene.com ↗
Circulating tumor DNA (ctDNA) dynamics associate with treatment response and radiological progression-free survival (rPFS): analyses from a randomized phase II trial in metastatic castration-resistant prostate cancer (mCRPC) |
| 2019-11-18 | Hoffmann-La Roche | Results Roche to present new and updated data for seven approved and investigational medicines across multiple types of breast cancer at the 2019 San Antonio Breast Cancer Symposium roche.com ↗
Expression of PD-L1 is independent of PIK3CA/AKT1/PTEN alterations in TNBC and is not associated with response to ipatasertib plus paclitaxel |
| 2019-04-01 | Hoffmann-La Roche | Results Roche's ipatasertib in combination with Tecentriq and chemotherapy shows promising anti-tumour activity in triple-negative breast cancer in early phase trial roche.com ↗
Combination treatment demonstrated a confirmed objective response rate (ORR) of 73% (95% CI 53-88%), irrespective of tumour biomarker status. |
All press releases naming this drug 6 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 57 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ipatasertib | “Ipatasertib (GDC-0068) is a novel selective ATP-competitive small-molecule inhibitor of AKT that preferentially targets active phosphorylated AKT (pAKT)” PMID 27872130 ↗ Nov 201654“200 mg oral ipatasertib followed 1 hour later by 80-mcg/800-nCi intravenous \[14C\]-ipatasertib on Day 1 of study” NCT02390492 ↗ “Ipatasertib (GDC-0068) is a highly selective pan-Akt inhibitor targeting Akt1/2/3 .” NCT02430363 ↗ |
| Known as | GDC-0068 | “A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of \[14C\]-Ipatasertib (GDC-0068) Following a Single Oral Dose and to Investigate the Absolute...” NCT02390492 ↗5“A Phase Ib, Open-label, Dose-escalation Study of the Safety and Pharmacology of Ipatasertib (GDC-0068) in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin,...” NCT01362374 ↗ “A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer” NCT01896531 ↗ “A Phase 1, Single-Dose, Randomized, Cross-Over, Relative Bioavailability, and Food Effect Study of Ipatasertib (GDC-0068) in Healthy Subjects” NCT02536391 ↗ “A Phase 1, Open-Label Study to Evaluate the Effect of Formulation on the Bioavailability of Ipatasertib (GDC-0068) in Healthy Subjects” NCT02063581 ↗ |
| Known as | ipat | “ipatasertib (ipat) in combination with atezolizumab (atezo) and paclitaxel (pac) or nab-paclitaxel” NCT03800836 ↗ |
| Known as | RG-7440 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2177390 ↗ |
| Action | Inhibit | “small-molecule inhibitor of AKT” PMID 27872130 ↗ Nov 2016 |
| Modality | Small molecule | “Ipatasertib (GDC-0068) is a novel selective ATP-competitive small-molecule inhibitor of AKT” PMID 27872130 ↗ Nov 2016 |
| Route | Oral | “Oral repeating dose” NCT01090960 ↗ |
| Target | AKT1 | “Ipatasertib (GDC-0068) is a highly selective pan-Akt inhibitor targeting Akt1/2/3 .” NCT02430363 ↗ |