6 completed, 5 terminated, 1 active not recruiting, 1 recruiting. 13 Phase 1, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 13 | Completed 6, Terminated 5, Active not recruiting 1, Withdrawn 1 |
| Phase 2 | 5 | Terminated 2, Active not recruiting 1, Recruiting 1, Withdrawn 1 |
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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 Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant Siremadlin - Acute Myeloid Leukemia, Allogeneic Stem Cell Transplantation | Phase 1 / Phase 2 | Terminated | Novartis Pharmaceuticals | 8 | 2023-02-23 | 2025-05-16 |
| Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment Siremadlin - Hepatic Impairment | Phase 1 | Completed | Novartis Pharmaceuticals | 38 | 2022-12-02 | 2025-07-09 |
| A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy. siremadlin, venetoclax, azacitidine - Acute Myeloid Leukemia | Phase 1 | Completed | Novartis Pharmaceuticals | 14 | 2022-05-17 | 2026-05-07 |
| HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas Pazopanib, HDM201 - Advanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma | Phase 1 / Phase 2 | Active not recruiting | Centre Leon Berard | 47 | 2022-04-15 | 2026-06-22 |
| HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt. HDM201, Midostaurin - AML, Adult | Phase 1 | Terminated | Insel Gruppe AG, University Hospital Bern | 2 | 2020-07-13 | 2022-10-06 |
| A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. HDM201, Ribociclib, Cabozantinib - Malignant Solid Tumor | Phase 2 | Recruiting | Centre Leon Berard | 455 | 2020-01-28 | 2026-07-08 |
| HDM201 Added to CT in R/R or Newly Diagnosed AML HDM201, cytarabine, anthracycline - Leukemia, Myeloid, Acute | Phase 1 / Phase 2 | Withdrawn | Novartis Pharmaceuticals | 2019-11-15 | 2020-01-09 | |
| Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients Ruxolitinib, Siremadlin, Crizanlizumab - Myelofibrosis | Phase 1 / Phase 2 | Terminated | Novartis Pharmaceuticals | 45 | 2019-09-26 | 2025-08-07 |
| HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS) HDM201, MBG453, Venetoclax - Acute Myeloid Leukemia (AML), High-risk Myelodysplastic Syndrome (MDS) | Phase 1 | Terminated | Novartis Pharmaceuticals | 52 | 2019-06-24 | 2025-10-10 |
| Trametinib + HDM201 in CRC Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer Mutant and TP53 Wild-type HDM201, Trametinib - Colorectal Cancer, Advanced Cancer | Phase 1 | Completed | Centre Leon Berard | 12 | 2018-12-20 | 2023-09-13 |
| A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat PDR001, LCL161, Everolimus - Colorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell Carcinoma | Phase 1 | Completed | Novartis Pharmaceuticals | 298 | 2016-10-14 | 2023-01-11 |
| A Phase I Study of LXS196 in Patients With Metastatic Uveal Melanoma. LXS196, LXS196 and HDM201 - Uveal Melanoma | Phase 1 | Terminated | Novartis Pharmaceuticals | 107 | 2016-02-01 | 2022-09-29 |
| Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma HDM201, LEE011 - Liposarcoma | Phase 1 | Completed | Novartis Pharmaceuticals | 74 | 2015-03-13 | 2020-12-09 |
| Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt HDM201, ancillary treatment - Advanced Solid and Hematological TP53wt Tumors | Phase 1 | Completed | Novartis Pharmaceuticals | 208 | 2014-07-07 | 2021-05-21 |
Leukemia, Myeloid, Acute (5) · Colorectal Neoplasms (2) · Neoplasm Metastasis (2) · Adenocarcinoma (1) · Carcinoma, Non-Small-Cell Lung (1) · Carcinoma, Renal Cell (1) · Hematologic Neoplasms (1) · Liposarcoma (1) · Neoplasm, Residual (1) · Primary Myelofibrosis (1) · Sarcoma (1) · Triple Negative Breast Neoplasms (1) · Uveal Melanoma (1)
Novartis Pharmaceuticals (10) · Centre Leon Berard (3) · Insel Gruppe AG, University Hospital Bern (1)
Spain (7) · France (6) · Germany (6) · United States (6) · Italy (4) · Netherlands (4) · Australia (3) · Singapore (3) · Taiwan (3) · Canada (2) · Hungary (2) · Switzerland (2) · Turkey (Türkiye) (2) · United Kingdom (2) · Denmark (1)
2018 (2), 2019 (2), 2023 (1)