12 completed, 7 terminated, 4 withdrawn, 2 active not recruiting. 15 Phase 1, 13 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 15 | Completed 10, Terminated 4, Unknown 1 |
| Phase 2 | 13 | Terminated 6, Withdrawn 3, Active not recruiting 2, Completed 1, Unknown 1 |
| Phase 3 | 2 | Completed 1, Withdrawn 1 |
Follow dactolisib: new trials by email Literature Review of dactolisib trials Research Report on dactolisib
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 |
|---|---|---|---|---|---|---|
| A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults RTB101, Placebo - Covid19 | Phase 2 | Active not recruiting | Restorbio Inc. | 60 | 2020-10-13 | 2021-02-09 |
| Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes RTB101, Placebo - COVID19 | Phase 2 | Terminated | Restorbio Inc. | 36 | 2020-07-11 | 2021-02-10 |
| Effect of RTB101 on Illness Associated With Respiratory Tract Infections in the Elderly Dactolisib, Placebo - Clinically Symptomatic Respiratory Illness | Phase 3 | Withdrawn | Restorbio Inc. | 2019-10-21 | 2019-11-22 | |
| A Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly Dactolisib, Placebo - Respiratory Tract Infections | Phase 3 | Completed | Restorbio Inc. | 1024 | 2019-04-15 | 2021-06-23 |
| Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly Placebo, BEZ235, BEZ235 plus everolimus (RAD001) - Respiratory Tract Infections | Phase 2 | Active not recruiting | Restorbio Inc. | 652 | 2017-11-15 | 2018-05-16 |
| Evaluation Of The Treatment Effectiveness Of Glioblastoma / Gliosarcoma Through The Suppression Of The PI3K/Akt Pathway In Compared With MK-3475 MK - 3475, Suppressor of the PI3K/Akt pathways - Glioblastoma | Phase 1 / Phase 2 | Unknown | Medical Research Council | 58 | 2013-03-01 | 2016-02-24 |
| Study of BEZ235 as Monotherapy in Patients With Transitional Cell Carcinoma After Failure of Platinum Based Chemotherapy BEZ235 - Carcinoma Transitional Cell | Phase 2 | Terminated | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | 22 | 2013-02-01 | 2019-04-10 |
| A Multicenter Phase I/II Trial of Abiraterone Acetate + BEZ235 in Metastatic, Castration-Resistant Prostate Cancer BEZ235, Prednisone, Abiraterone acetate - Castrate-resistant Prostate Cancer | Phase 1 / Phase 2 | Terminated | Charles Ryan | 6 | 2013-01-31 | 2018-03-27 |
| BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy. BEZ235 (Stage 1) - Pancreatic Neuroendocrine Tumors (pNET) | Phase 2 | Completed | Novartis Pharmaceuticals | 31 | 2012-11-01 | 2016-05-02 |
| Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors BEZ235, Everolimus - Pancreatic Neuroendocrine Tumors (pNET) | Phase 2 | Terminated | Novartis Pharmaceuticals | 62 | 2012-10-01 | 2016-04-07 |
| Phase Ib of Abiraterone Acetate Plus BEZ235 or BKM120 in Castration-resistant Prostate Cancer (CRPC) Patients BEZ235, BKM120 - Castration-resistant Prostate Cancer | Phase 1 | Completed | Novartis Pharmaceuticals | 43 | 2012-09-01 | 2020-12-09 |
| A Phase II Study of Orally Administered BEZ235 Monotherapy in Patients With Metastatic or Unresectable Malignant PEComa BEZ235 - Malignant PEComa (Perivascular Epithelioid Cell Tumors) | Phase 2 | Withdrawn | Novartis Pharmaceuticals | 2012-09-01 | 2013-08-02 | |
| A Phase I, Dose-finding Study of BEZ235 in Adult Patients With Relapsed or Refractory Acute Leukemia BEZ235 - Acute Lymphoblastic Leukemia, Leukemia, Myelocytic, Acute | Phase 1 | Completed | Goethe University | 24 | 2012-06-01 | 2023-02-16 |
| BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer BEZ235 - Metastatic Breast Cancer | Phase 2 | Withdrawn | Novartis Pharmaceuticals | 2012-03-01 | 2012-06-07 | |
| BEZ235 Trial in Patients With Advanced Endometrial Carcinoma BEZ235 - Endometrial Cancer | Phase 2 | Withdrawn | Novartis Pharmaceuticals | 2012-03-01 | 2012-06-21 | |
| A Phase Ib/II Study of BEZ235 and Trastuzumab in Patients With HER2-positive Breast Cancer Who Failed Prior to Trastuzumab BEZ235 + Trastuzumab Phase l/Phase ll), Lapatinib + Capecitabine (Phase II) - Locally Advance Breast Cancer (LABC), Metastatic Breast Cancer (MBC) | Phase 1 | Completed | Novartis Pharmaceuticals | 5 | 2012-02-01 | 2020-12-09 |
| Phase Ib/II Trial of BEZ235 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer BEZ235, Paclitaxel - Inoperable Locally Advanced Breast Cancer, Metastatic Breast Cancer (MBC) | Phase 1 / Phase 2 | Terminated | Novartis Pharmaceuticals | 18 | 2012-01-30 | 2020-12-08 |
| Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors RAD001 + BEZ235 - Advanced Solid Tumors, Metastatic Breast Cancer | Phase 1 | Completed | Novartis Pharmaceuticals | 46 | 2012-01-01 | 2020-12-21 |
| Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors BEZ235, Everolimus - Cancer | Phase 1 | Terminated | University of Cincinnati | 19 | 2012-01-01 | 2017-08-23 |
| BEZ235 in Patients With Advanced Renal Cell Carcinoma (RCC) BEZ235 - Renal Cancer | Phase 1 / Phase 2 | Terminated | Memorial Sloan Kettering Cancer Center | 10 | 2011-10-01 | 2016-02-29 |
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Breast Neoplasms (6) · Hereditary Sensory and Autonomic Neuropathies (3) · Neoplasm Metastasis (3) · Neoplasms (3) · Respiratory Tract Infections (3) · Virus Diseases (3) · COVID-19 (2) · Carcinoma, Renal Cell (2) · Glioblastoma (2) · Neuroectodermal Tumors, Primitive (2) · Neuroendocrine Tumors (2) · Angiomyolipoma (1) · Brain Neoplasms (1) · Breast Diseases (1) · Carcinoma, Transitional Cell (1)
Novartis Pharmaceuticals (12) · Restorbio Inc. (5) · Charles Ryan (1) · Cliniques universitaires Saint-Luc- Université Catholique de Louvain (1) · Goethe University (1) · Medical Research Council (1) · Memorial Sloan Kettering Cancer Center (1) · Pfizer (1) · SCRI Development Innovations, LLC (1) · University of Cincinnati (1) · Vanderbilt-Ingram Cancer Center (1)
United States (16) · Spain (12) · France (7) · United Kingdom (7) · Belgium (6) · Germany (6) · Italy (5) · Netherlands (4) · Canada (3) · Russia (3) · Switzerland (3) · Japan (2) · New Zealand (2) · Poland (2) · Australia (1)
Ana Molina, MD (1) · Charles Ryan, MD (1) · Dean Quinn, MD (1) · Ingrid Mayer, MD (1) · Jann Lee, PhD (1) · Jean-Pascal Machiels, MD, PhD (1) · Joerg Chromik, Dr. (1) · Johanna C Bendell, M.D. (1) · John Morris, MD (1) · Sarb Shergill, PhD (1)
PMID 26851029, PMID 27286790, PMID 28314838, PMID 28357727, PMID 29242283, PMID 30446785, PMID 32993794, PMID 33977284
R01AG064802 (1)