40 completed, 4 recruiting, 3 withdrawn, 2 active not recruiting. 51 Phase 1, 19 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 51 | Completed 40, Recruiting 4, Withdrawn 3, Active not recruiting 2, Terminated 1, Unknown 1 |
| Phase 2 | 19 | Completed 12, Active not recruiting 2, Recruiting 2, Withdrawn 2, Unknown 1 |
Follow Neoplasms, Multiple Primary: new trials by email Literature Review of Neoplasms, Multiple Primary trials Research Report on Neoplasms, Multiple Primary
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 |
|---|---|---|---|---|---|---|
| Safety, Tolerability, and Pharmacokinetics of SVG103 (Paxalisib) in Focal Cortical Dysplasia Type II (FCD-II), Tuberous Sclerosis Complex (TSC) or Hemimegalencephaly (HME) SVG103 - Focal Cortical Dysplasia, Tuberous Sclerosis Complex (TSC) | Phase 1 / Phase 2 | Recruiting | Sovargen | 12 | 2026-07-14 | 2026-08-10 |
| Sapu003 in Advanced mTOR-sensitive Solid Tumors Sapu003, Exemestane 25 MG - Breast Cancer Metastatic, Renal Cell Carcinoma (RCC) | Phase 1 | Recruiting | SAPU NANO (US) LLC | 27 | 2025-12-15 | 2026-01-27 |
| Phase 1, Open-label, Drug-drug Interaction Study to Assess Effect Between Radiprodil and the Co-administered Drugs. Radiprodil + co-administered drugs - Tuberous Sclerosis Complex (TSC), Focal Cortical Dysplasia | Phase 1 | Completed | GRIN Therapeutics, Inc. | 18 | 2025-05-20 | 2025-11-18 |
| Study to Evaluate the Pharmacokinetics and Safety Effects Following Coadministration of Carbamazepine or Itraconazole With Radiprodil in Healthy Adults Radiprodil with Carbamazepine, Radiprodil with Itraconazole - Tuberous Sclerosis Complex (TSC), Focal Cortical Dysplasia | Phase 1 | Terminated | GRIN Therapeutics, Inc. | 30 | 2025-05-08 | 2025-11-21 |
| Open Label, Dose Escalation, Repeat Dose Study Evaluating YCT-529 in Healthy Males YCT-529 - Male Contraception | Phase 1 / Phase 2 | Recruiting | YourChoice Therapeutics, Inc. | 88 | 2024-09-11 | 2026-02-13 |
| Astroscape: A Study of Radiprodil on Safety, Tolerability, Pharmacokinetics, and Effect on Seizures and Behavioral Symptoms in Patients With TSC or FCD Type II Radiprodil - Tuberous Sclerosis Complex, Focal Cortical Dysplasia | Phase 1 / Phase 2 | Active not recruiting | GRIN Therapeutics, Inc. | 30 | 2024-07-10 | 2026-04-01 |
| Sirolimus for Improving Social Abilities in People With PTEN Germline Mutations Sirolimus, Placebo - PTEN Gene Mutation, PTEN Hamartoma Tumor Syndrome | Phase 1 / Phase 2 | Withdrawn | Stanford University | 2024-07-01 | 2024-07-10 | |
| A Study to Learn if Elinzanetant Affects the Ability to Drive and Brain Function in Healthy Women Elinzanetant (BAY3427080), Placebo to elinzanetant, Zopiclone - Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes | Phase 1 | Completed | Bayer | 64 | 2024-01-08 | 2024-05-08 |
| A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants Moxifloxacin, Elinzanetant (BAY3427080), Placebo - Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes | Phase 1 | Completed | Bayer | 51 | 2022-08-19 | 2023-05-09 |
| A Study to Learn How the Study Drug Elinzanetant (BAY 3427080) Affects the Way the Drug Dabigatran Moves Into, Through and Out of the Body in Healthy Male and Female Participants Elinzanetant (BAY3427080), Dabigatran etexilate - Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes | Phase 1 | Completed | Bayer | 20 | 2022-08-05 | 2022-11-22 |
| Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer BNT116, Cemiplimab, Docetaxel - Non-Small Cell Lung Cancer | Phase 1 | Recruiting | BioNTech SE | 320 | 2022-06-17 | 2026-07-22 |
| A Study to Learn More About How the Study Treatment Elinzanetant (or BAY3427080) Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body After Taking Single and Multiple Doses in Healthy Women Aged 40 to 65 Years Elinzanetant (BAY3427080), Placebo - Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes | Phase 1 | Completed | Bayer | 16 | 2022-05-23 | 2022-07-27 |
| A Study to Learn More About How Much of the Study Treatment Elinzanetant (or BAY3427080) Gets Absorbed, How Safe it is and How it Affects the Body in Healthy Female and Male Participants Elinzanetant (BAY3427080) - Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes | Phase 1 | Completed | Bayer | 18 | 2022-05-04 | 2022-07-19 |
| Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies LP352, Placebo - Developmental and Epileptic Encephalopathy, Dravet Syndrome | Phase 1 / Phase 2 | Completed | Longboard Pharmaceuticals | 52 | 2022-03-03 | 2024-11-08 |
| A Study to Learn How Elinzanetant Moves Into, Through, and Out of the Body, How Safe it is, and How it Affects the Body in Participants With Kidneys That do Not Work as Well as They Should Compared to Participants Whose Kidneys Work Normally Elinzanetant (BAY3427080) - Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men | Phase 1 | Completed | Bayer | 31 | 2021-10-14 | 2025-07-14 |
| A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults Elinzanetant (BAY3427080), Esomeprazole - Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes | Phase 1 | Completed | Bayer | 14 | 2021-09-30 | 2022-03-17 |
| A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years. Elinzanetant (BAY3427080), Midazolam, Carbamazepine - Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men | Phase 1 | Completed | Bayer | 16 | 2021-09-06 | 2022-02-25 |
| Feasibility of [11C]Acetate-PET in LAM and TSC [11C]acetate - Lymphangioleiomyomatosis, Tuberous Sclerosis Complex | Phase 1 / Phase 2 | Active not recruiting | Brigham and Women's Hospital | 7 | 2021-08-30 | 2026-01-21 |
| A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female Adults Elinzanetant (BAY3427080), Placebo - Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men | Phase 1 | Completed | Bayer | 62 | 2021-08-11 | 2022-03-29 |
| A Study to Learn How Different Levels of Decreased Liver Function Influence Blood Levels of Elinzanetant Compared to Normal Liver Function in Male and Female Participants BAY3427080 - Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men | Phase 1 | Completed | Bayer | 33 | 2021-06-01 | 2022-03-24 |
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Multiple Endocrine Neoplasia Type 1 (24) · Tuberous Sclerosis (16) · Hot Flashes (7) · Multiple Endocrine Neoplasia Type 2a (7) · Carcinoma, Medullary (4) · Focal Cortical Dysplasia (4) · Hamartoma Syndrome, Multiple (4) · Hereditary Sensory and Autonomic Neuropathies (4) · Carcinoma, Non-Small-Cell Lung (3) · Epilepsy (3) · Lymphangioleiomyomatosis (3) · Neuroendocrine Tumors (3) · Angiofibroma (2) · Breast Neoplasms (2) · Homosexuality (2)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (51) · Genetic Diseases, Inborn (50) · Neoplastic Syndromes, Hereditary (50) · Neoplasms (49) · Neoplasms by Site (32) · Endocrine Gland Neoplasms (29) · Endocrine System Diseases (29) · Multiple Endocrine Neoplasia (29) · Hamartoma (21) · Nervous System Diseases (20) · Congenital Abnormalities (18) · Neurodegenerative Diseases (18) · Heredodegenerative Disorders, Nervous System (17) · Nervous System Malformations (17)
Everolimus (7) · Sirolimus (5) · radiprodil (3) · Carbamazepine (2) · 8-(6-methoxypyridin-3-yl)-3-methyl-1-(4-piperazin-1-yl-3-trifluoromethylphenyl)-1,3-dihydroimidazo(4,5-c)quinolin-2-one (1) · Acetazolamide (1) · Antibodies, Bispecific (1) · Capecitabine (1) · Carboplatin (1) · Cholecalciferol (1) · Dabigatran (1) · Docetaxel (1) · Esomeprazole (1) · Ethanol (1) · GSK3352589 (1)
Bayer (12) · Children's Hospital Medical Center, Cincinnati (5) · GlaxoSmithKline (4) · GRIN Therapeutics, Inc. (3) · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (2) · Novartis Pharmaceuticals (2) · BioNTech SE (1) · Boston Children's Hospital (1) · Boston Pharmaceuticals (1) · Brigham and Women's Hospital (1) · Colorado State University (1) · Hadassah Medical Organization (1) · Hoffmann-La Roche (1) · Le Bonheur Children's Hospital (1) · Longboard Pharmaceuticals (1)
United States (27) · Germany (10) · Australia (9) · Spain (6) · Netherlands (5) · United Kingdom (4) · Belgium (3) · Canada (3) · China (2) · France (2) · Hong Kong (2) · Italy (2) · Poland (2) · South Korea (2) · Taiwan (2)
Antonio Hardan, MD (1) · Brigitte C Widemann, M.D. (1) · Carmen P Priolo, MD PhD (1) · Darcy Krueger, M.D. Ph.D (1) · Darcy Krueger, MD, PhD (1) · David N Franz, M.D. (1) · Dennis J Dlugos, MD (1) · Frank McCormack, MD (1) · Hope Northrup, MD (1) · James W Wheless, MD (1)
PMID 21047224, PMID 21482669, PMID 22262746, PMID 22934754, PMID 23325902, PMID 23766359, PMID 23798472, PMID 24617713, PMID 25578927, PMID 25972901, PMID 26381530, PMID 27282116, PMID 29023494, PMID 29187393, PMID 30277655, PMID 30424962, PMID 30803705, PMID 33606922, PMID 34118197, PMID 34118198, PMID 34649967, PMID 35594551, PMID 35715405, PMID 35962206, PMID 37282666, PMID 37916501, PMID 37934000, PMID 38009200, PMID 39331837, PMID 40569207, PMID 40639400, PMID 41886723
2023 (2), 2016 (1), 2018 (1), K08MH094441 (1), R01AA022301 (1), U54NS092090 (1)