7 completed, 3 terminated, 2 recruiting, 1 unknown. 9 Phase 1, 7 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 9 | Completed 4, Terminated 3, Recruiting 1, Unknown 1 |
| Phase 2 | 7 | Completed 3, Recruiting 2, Terminated 1, Unknown 1 |
Follow serabelisib: new trials by email Literature Review of serabelisib trials Research Report on serabelisib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer Serabelisib, Sapanisertib, Fulvestrant - HR+ HER2- Breast Cancer | Phase 1 / Phase 2 | Recruiting | Faeth Therapeutics | 32 | 2026-04-22 | 2026-07-02 |
| Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer Sapanisertib, Serabelisib, Paclitaxel - Endometrial Cancer | Phase 2 | Recruiting | Faeth Therapeutics | 40 | 2024-12-12 | 2025-12-24 |
| Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations Serabelisib, Insulin Suppressing Diet, Nab paclitaxel - Advanced Solid Tumor, PIK3CA Mutation | Phase 1 | Terminated | Faeth Therapeutics | 34 | 2022-04-22 | 2026-04-30 |
| A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors Serabelisib, Canagliflozin 300mg - Breast Cancer, Endometrial Cancer | Phase 1 / Phase 2 | Unknown | Petra Pharma | 60 | 2020-09-01 | 2020-05-21 |
| TAK-228 and TAK-117 Followed by Cisplatin and Nab Paclitaxel for Metastatic Triple Negative Breast Cancer Tak-228 & Tak-117, Cisplatin & Nab Paclitaxel - Triple Negative Breast Cancer | Phase 2 | Completed | Joyce O'Shaughnessy | 12 | 2017-07-18 | 2023-08-07 |
| Evaluation of the Safety and Tolerability of TAK-228 With TAK-117 and Paclitaxel in Advanced Solid Tumors paclitaxel, TAK-228, TAK-117 - Advanced Solid Tumor | Phase 1 | Completed | Avera McKennan Hospital & University Health Center | 19 | 2017-07-06 | 2024-07-26 |
| MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Everolimus, MLN0128, MLN1117 - Clear-cell Metastatic Renal Cell Carcinoma | Phase 2 | Completed | Millennium Pharmaceuticals, Inc. | 96 | 2016-06-30 | 2021-11-19 |
| A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer Paclitaxel, Sapanisertib, MLN1117 - Endometrial Neoplasms | Phase 2 | Completed | Millennium Pharmaceuticals, Inc. | 241 | 2016-04-01 | 2021-11-24 |
| A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants TAK-117, Lansoprazole - Neoplasm, Advanced or Metastatic | Phase 1 | Completed | Millennium Pharmaceuticals, Inc. | 54 | 2016-01-08 | 2018-01-08 |
| MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma MLN1117, TAK-659, Alisertib - Advanced and Metastatic Gastric or Gastroesophageal Adenocarcinoma | Phase 1 | Terminated | Millennium Pharmaceuticals, Inc. | 32 | 2015-10-15 | 2019-09-20 |
| Docetaxel With or Without TAK-117 (MLN1117) in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer Docetaxel, TAK-117 - Non-small Cell Lung Cancer | Phase 1 / Phase 2 | Terminated | Millennium Pharmaceuticals, Inc. | 14 | 2015-06-03 | 2018-02-07 |
| A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies TAK-228, TAK-117 - Advanced Nonhematologic Malignancies | Phase 1 | Completed | Millennium Pharmaceuticals, Inc. | 101 | 2013-06-28 | 2019-10-30 |
| Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer TAK-117 - Metastatic Solid Tumors | Phase 1 | Completed | Millennium Pharmaceuticals, Inc. | 125 | 2011-10-01 | 2017-03-09 |
Endometrial Neoplasms (3) · Hereditary Sensory and Autonomic Neuropathies (3) · Breast Neoplasms (2) · Neoplasms (2) · Carcinoma, Endometrioid (1) · Carcinoma, Non-Small-Cell Lung (1) · Clear-cell metastatic renal cell carcinoma (1) · Colonic Neoplasms (1) · Genital Diseases (1) · Head and Neck Neoplasms (1) · Lung Neoplasms (1) · Neoplasm Metastasis (1) · Triple Negative Breast Neoplasms (1)
Millennium Pharmaceuticals, Inc. (7) · Faeth Therapeutics (3) · Avera McKennan Hospital & University Health Center (1) · Joyce O'Shaughnessy (1) · Petra Pharma (1)
United States (11) · Spain (5) · United Kingdom (4) · Canada (3) · Italy (2) · Netherlands (2) · Australia (1) · Belgium (1) · Czechia (1) · France (1) · Germany (1) · Norway (1) · Poland (1)
Albert Yu, MD (1) · Casey Williams, PharmD (1) · Joyce O'Shaughnessy, MD (1) · Vicky Makker (1)
PMID 35843739, PMID 37491309, PMID 37839313
2014 (2), 2015 (2)