Ipatasertib
Information
- Drug Name
- Ipatasertib
- Description
- Entry(CIViC)
- 1
CIViC
| Disease | Mutation | EL | ET | ED | CS | VO | TR | Pubmed | Links |
|---|---|---|---|---|---|---|---|---|---|
| cancer | PTEN MUTATION PTEN MUTATION | D |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 3 | 23287563 | Detail |
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| IC50 for the pan-Akt inhibitor ipatasertib (GDC-00... | PTEN | PTEN MUTATION PTEN MUTATION | Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT03280563 | Active, not recruiting | Phase 1/Phase 2 | A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer | December 26, 2017 | December 31, 2024 |
| NCT03337698 | Active, not recruiting | Phase 1/Phase 2 | A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) | January 2, 2018 | November 30, 2026 |
| NCT04931342 | Active, not recruiting | Phase 2 | A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors | October 7, 2021 | December 31, 2028 |
| NCT03959891 | Active, not recruiting | Phase 1 | AKT Inhibitor, Ipatasertib, With Endocrine and CDK 4/6 Inhibitor for Patients With Metastatic Breast Cancer (TAKTIC) | May 30, 2019 | December 2024 |
| NCT05498896 | Active, not recruiting | Phase 2 | Investigate the Contribution of Ipatasertib to Neoadjuvant Chemotherapy Plus Atezolizumab in TNBC | December 19, 2018 | January 30, 2026 |
| NCT04650581 | Active, not recruiting | Phase 3 | Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor | January 27, 2021 | December 31, 2026 |
| NCT03385655 | Active, not recruiting | Phase 2 | Prostate Cancer Biomarker Enrichment and Treatment Selection | August 1, 2018 | December 31, 2025 |
| NCT02465060 | Active, not recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | August 17, 2015 | December 31, 2025 |
| NCT04591431 | Active, not recruiting | Phase 2 | The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy | October 7, 2020 | June 2025 |
| NCT03498521 | Active, not recruiting | Phase 2 | A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site | July 10, 2018 | June 9, 2024 |
| NCT06400251 | Active, not recruiting | Phase 2 | Testing Ipatasertib as Potentially Targeted Treatment in Cancers With AKT Genetic Changes (MATCH - Subprotocol Z1K) | July 24, 2019 | March 3, 2025 |
| NCT03853707 | Completed | Phase 1/Phase 2 | Ipatasertib in Combination With Carboplatin, Carboplatin/Paclitaxel, or Capecitabine/Atezolizumab in Treating Patients With Metastatic Triple Negative Breast Cancer | March 4, 2019 | September 19, 2023 |
| NCT04177108 | Completed | Phase 3 | A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer | November 25, 2019 | February 28, 2023 |
| NCT01562275 | Completed | Phase 1 | A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors | April 2012 | January 2015 |
| NCT04341259 | Completed | Phase 1 | A Study Of The Pharmacokinetics And Safety Of Ipatasertib In Chinese Participants With Locally Advanced Or Metastatic Solid Tumors. | November 3, 2020 | April 6, 2023 |
| NCT01362374 | Completed | Phase 1 | Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors | July 11, 2011 | October 16, 2020 |
| NCT04464174 | Completed | Phase 2 | Ipatasertib Plus Non-Taxane Chemotherapy for Advanced or Metastatic Triple-Negative Breast Cancer | October 8, 2020 | November 10, 2023 |
| NCT02162719 | Completed | Phase 2 | A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors | August 19, 2014 | August 31, 2019 |
| NCT01896531 | Completed | Phase 2 | A Study of Ipatasertib (GDC-0068) in Combination With Fluoropyrimidine Plus Oxaliplatin in Participants With Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer | August 14, 2013 | January 26, 2021 |
| NCT02301988 | Completed | Phase 2 | A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer | February 17, 2015 | August 2, 2017 |
| NCT04632992 | Completed | Phase 2 | A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response | January 13, 2021 | February 27, 2024 |
| NCT03072238 | Completed | Phase 3 | Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer | June 30, 2017 | April 24, 2024 |
| NCT03222310 | Completed | Phase 1 | A Study to Evaluate the Effect of a Potent Cytochrome P450 (CYP) 3A Inhibitor on Ipatasertib | July 18, 2017 | September 6, 2017 |
| NCT03337724 | Completed | Phase 3 | A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer | January 6, 2018 | January 4, 2023 |
| NCT03341884 | Completed | Phase 1 | A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants | November 9, 2017 | June 26, 2018 |
| NCT03395899 | Completed | Phase 2 | Pre-operative Immunotherapy Combination Strategies in Breast Cancer | December 21, 2017 | August 18, 2023 |
| NCT01485861 | Completed | Phase 1/Phase 2 | Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy | January 11, 2012 | August 31, 2022 |
| NCT03800836 | Completed | Phase 1 | A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer | February 13, 2018 | March 15, 2022 |
| NCT03840200 | Completed | Phase 1 | A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer. | June 12, 2019 | January 4, 2022 |
| NCT05332561 | Recruiting | Phase 2 | Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE) | June 29, 2023 | December 2030 |
| NCT03424005 | Recruiting | Phase 1/Phase 2 | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer | April 2, 2018 | May 3, 2026 |
| NCT04253561 | Recruiting | Phase 1 | Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients | February 25, 2020 | August 25, 2025 |
| NCT04467801 | Recruiting | Phase 2 | Ipatasertib and Docetaxel in Metastatic NSCLC Patients Who Have Failed 1st Line Immunotherapy | September 14, 2021 | August 2025 |
| NCT04486352 | Recruiting | Phase 1/Phase 2 | A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer | October 20, 2021 | October 2026 |
| NCT04551521 | Recruiting | Phase 2 | CRAFT: The NCT-PMO-1602 Phase II Trial | October 13, 2021 | June 30, 2025 |
| NCT04589845 | Recruiting | Phase 2 | Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study | January 18, 2021 | September 25, 2032 |
| NCT05276973 | Recruiting | Phase 1 | Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) for Stage III or IV Epithelial Ovarian Cancer | September 8, 2022 | June 30, 2024 |
| NCT05538897 | Recruiting | Phase 1/Phase 2 | Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial Cancers | March 31, 2023 | January 31, 2027 |
| NCT05554380 | Recruiting | Phase 2 | Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With AKT Mutations, A ComboMATCH Treatment Trial | September 22, 2023 | August 31, 2025 |
| NCT05564377 | Recruiting | Phase 2 | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial | April 7, 2023 | July 1, 2030 |
| NCT05862285 | Recruiting | Phase 3 | A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study | June 1, 2023 | March 1, 2033 |
| NCT04802759 | Recruiting | Phase 1/Phase 2 | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer | June 20, 2021 | October 31, 2026 |
| NCT05172245 | Recruiting | Phase 1 | Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer | September 19, 2022 | June 1, 2026 |
| NCT05172258 | Recruiting | Phase 2 | Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck | July 26, 2022 | June 30, 2025 |
| NCT04737109 | Terminated | Phase 1/Phase 2 | Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer | July 13, 2021 | August 15, 2022 |
| NCT04404140 | Terminated | Phase 1 | A Study Evaluating The Safety, Efficacy and Pharmacokinetics Of Ipatasertib In Combination With Atezolizumab And Docetaxel In Metastatic Castration-Resistant Prostate Cancer (mCRPC). | July 9, 2020 | October 14, 2022 |
| NCT04060862 | Terminated | Phase 3 | A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer | November 15, 2019 | August 29, 2023 |
| NCT03673787 | Unknown status | Phase 1/Phase 2 | A Trial of Ipatasertib in Combination With Atezolizumab | August 13, 2018 | November 2023 |
| NCT04561817 | Withdrawn | Phase 2 | To Evaluate the Safety and Efficacy of Ipatasertib (GDC-0068) in Combination With Paclitaxel in Platinum-resistant Recurrent Epithelial Ovarian Cancer | October 1, 2020 | October 1, 2023 |
- Target (Drug list of Screening Committee of Anticancer Drugs)
- Akt
- Synonym (Drug list of Screening Committee of Anticancer Drugs)
- GDC-0068
- Synonym (Drug list of Screening Committee of Anticancer Drugs)
- RG7440