8 terminated, 6 completed, 1 withdrawn. 13 Phase 1, 9 Phase 2, 1 Phase 3.
By phase and status
Follow RG7388: new trials by email Literature Review of RG7388 trials Research Report on RG7388
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
Trial of Idasanutlin and Selinexor Therapy for Children With Progressive/Relapsed AT/RT or Extra-CNS Malignant Rhabdoid Tumors Idasanutlin, Selinexor - Rhabdoid Tumor, Atypical Teratoid/Rhabdoid Tumor Phase 1 Withdrawn St. Jude Children's Research Hospital 2024-03-01 2024-03-27 A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors Idasanutlin, Venetoclax, Cyclophosphamide - Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) Phase 1 / Phase 2 Terminated Hoffmann-La Roche 38 2020-01-27 2024-12-20 A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission Idasanutlin, Cytarabine, Daunorubicin - Acute Myeloid Leukemia Phase 1 / Phase 2 Terminated Hoffmann-La Roche 24 2019-03-25 2022-06-21 A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC) Regorafenib, Atezolizumab, Imprime PGG - Colorectal Cancer Phase 1 / Phase 2 Terminated Hoffmann-La Roche 96 2018-09-27 2023-11-07 Atezolizumab and Cobimetinib or Idasanutlin in Participants With Stage IV or Unresectable Recurrent Estrogen Receptor Positive Breast Cancer Atezolizumab, Cobimetinib, Idasanutlin - Stage III Breast Cancer, Stage IIIA Breast Cancer Phase 1 / Phase 2 Terminated Vanderbilt-Ingram Cancer Center 12 2018-07-10 2021-08-11 NCT Neuro Master Match - N²M² (NOA-20) APG101, Alectinib, Idasanutlin - Glioblastoma, Adult Phase 1 / Phase 2 Completed University Hospital Heidelberg 228 2018-05-07 2023-09-28 A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Idasanutlin Monotherapy in Participants With Hydroxyurea-Resistant/Intolerant Polycythemia Vera Idasanutlin - Polycythemia Vera Phase 2 Terminated Hoffmann-La Roche 27 2018-02-21 2021-12-08 A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors Idasanutlin - Solid Tumors Phase 1 Completed Hoffmann-La Roche 48 2017-11-27 2019-06-19 A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL) Idasanutlin, Obinutuzumab, Venetoclax - Follicular Lymphoma, Lymphoma, Large B-Cell, Diffuse Phase 1 / Phase 2 Terminated Hoffmann-La Roche 29 2017-06-15 2021-12-07 A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies) Idasanutlin, Placebo, [13C]-radiolabeled Idasanutlin - Solid Tumors Phase 1 Completed Hoffmann-La Roche 8 2016-09-08 2017-12-18 A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy Cobimetinib, Idasanutlin, Venetoclax - Leukemia, Myeloid, Acute Phase 1 Completed Hoffmann-La Roche 88 2016-03-09 2022-01-03 A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) Cytarabine, Idasanutlin, Placebo - Leukemia, Myeloid, Acute Phase 3 Terminated Hoffmann-La Roche 447 2015-12-30 2022-01-11 Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma Dexamethasone, Idasanutlin, Ixazomib Citrate - Loss of Chromosome 17p, Recurrent Plasma Cell Myeloma Phase 1 / Phase 2 Completed Mayo Clinic 33 2015-12-30 2024-09-19 A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants Idasanutlin, Obinutuzumab, Rituximab - Non-Hodgkin's Lymphoma Phase 1 / Phase 2 Terminated Hoffmann-La Roche 25 2015-12-23 2020-05-18 Open Label Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia RG7388, Pegasys - Polycythemia Vera, Essential Thrombocythemia Phase 1 Completed John Mascarenhas 13 2015-04-01 2019-09-12
Conditions studied Leukemia, Myeloid, Acute (4) · Polycythemia Vera (2) · Breast Neoplasms (1) · Central Nervous System Neoplasms (1) · Chromosome 17 deletion (1) · Colorectal Neoplasms (1) · Glioblastoma (1) · Hematologic Diseases (1) · Lymphoma, Follicular (1) · Lymphoma, Large B-Cell, Diffuse (1) · Lymphoma, Non-Hodgkin (1) · Multiple Myeloma (1) · Myeloproliferative Disorders (1) · Neuroblastoma (1) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (1)
Sponsors Hoffmann-La Roche (10) · John Mascarenhas (1) · Mayo Clinic (1) · St. Jude Children's Research Hospital (1) · University Hospital Heidelberg (1) · Vanderbilt-Ingram Cancer Center (1)
Countries United States (12) · Australia (6) · Canada (5) · France (5) · Germany (4) · Italy (4) · South Korea (4) · New Zealand (3) · Spain (3) · Netherlands (2) · Switzerland (2) · United Kingdom (2) · Austria (1) · Belgium (1) · Finland (1)
Top investigators Amar Gajjar, MD (1) · Ingrid Mayer, MD (1) · John Mascarenhas, MD (1) · Ronald Hoffman, MD (1) · Shaji Kumar, M.D. (1) · Wolfgang Wick, Prof. Dr. (1)
Results publications PMID 31167802 , PMID 32167393 , PMID 34933330 , PMID 36265087 , PMID 40913172 , PMID 41379293
NIH funding 2015 (4), 2017 (2), 2018 (2), 2014 (1), 2016 (1)