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    DRUG:

    Onivyde (nanoliposomal irinotecan)

    i
    Company:
    Ipsen, PharmaEngine, Servier, Yakult Honsha
    Drug class:
    Topoisomerase I inhibitor
    Related drugs:
    Apply
    Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease (NCT06023641)
    Phase 1/2
    St. Jude Children's Research Hospital
    Recruiting
    Last update posted :
    02/24/2025
    Initiation :
    03/13/2024
    Primary completion :
    10/01/2034
    Completion :
    10/01/2037
    TP53 • FOXO1 • MYOD1
    |
    TP53 mutation
    |
    temozolomide • cyclophosphamide • vincristine • vinorelbine tartrate • dactinomycin • Onivyde (nanoliposomal irinotecan) • Navelbine oral (vinorelbine tartrate oral) • Neupogen (filgrastim)
    Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma (NCT04901702)
    Phase 1/2
    St. Jude Children's Research Hospital
    Active, not recruiting
    Last update posted :
    02/24/2025
    Initiation :
    06/09/2021
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    EWSR1 • FLI1
    |
    temozolomide • Talzenna (talazoparib) • Onivyde (nanoliposomal irinotecan)
    Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors (NCT02631733)
    Phase 1
    National Cancer Institute (NCI)
    Completed
    Last update posted :
    02/10/2025
    Initiation :
    05/31/2017
    Primary completion :
    11/21/2019
    Completion :
    05/24/2023
    BRCA
    |
    BRCA mutation
    |
    veliparib (ABT-888) • Onivyde (nanoliposomal irinotecan)
    Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer (NCT03785873)
    Phase 1/2
    University of Michigan Rogel Cancer Center
    Completed
    Last update posted :
    12/18/2024
    Initiation :
    05/22/2019
    Primary completion :
    11/15/2024
    Completion :
    11/15/2024
    UGT1A1
    |
    UGT1A1*1*1
    |
    Opdivo (nivolumab) • 5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    Nal-IRI/5-FU/LV Chemotherapy Combined with PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT As Second-line Therapy in Metastatic Pancreatic Cancer Patients (NCT06662006)
    Phase 2
    The Affiliated Nanjing Drum Tower Hospital of N...
    Not yet recruiting
    Last update posted :
    10/28/2024
    Initiation :
    10/01/2024
    Primary completion :
    12/01/2027
    Completion :
    12/01/2027
    IFNG • IL6 • TNFA • IL2 • IL10 • IL17A • IFNA1 • IL1B
    |
    5-fluorouracil • Focus V (anlotinib) • Andewei (benmelstobart) • Onivyde (nanoliposomal irinotecan)
    AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 (CLARITY-PanTumor01) (NCT06219941)
    Phase 2
    AstraZeneca
    Recruiting
    Last update posted :
    06/13/2024
    Initiation :
    12/13/2023
    Primary completion :
    05/02/2025
    Completion :
    01/19/2027
    CLDN18
    |
    CLDN18.2 expression
    |
    gemcitabine • 5-fluorouracil • leucovorin calcium • sonesitatug vedotin (AZD0901) • Onivyde (nanoliposomal irinotecan)
    Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer (NCT03337087)
    Phase 1/2
    Academic and Community Cancer Research United
    Active, not recruiting
    Last update posted :
    05/17/2024
    Initiation :
    11/02/2018
    Primary completion :
    03/31/2021
    Completion :
    08/09/2025
    BRCA1 • BRCA2 • HRD • BRCA
    |
    BRCA2 mutation • BRCA1 mutation • HRD • PALB2 mutation • HRD + BRCA1 mutation
    |
    5-fluorouracil • Rubraca (rucaparib) • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • fluorouracil topical
    Evaluation of the Efficacy and Safety of Nal-IRI for Progressing Brain Metastases in Breast Cancer Patients (Phenomenal) (NCT03328884)
    Phase 2
    MedSIR
    Active, not recruiting
    Last update posted :
    04/16/2024
    Initiation :
    05/02/2017
    Primary completion :
    08/31/2018
    Completion :
    06/02/2025
    HER-2
    |
    HER-2 negative
    |
    irinotecan • Onivyde (nanoliposomal irinotecan)
    Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread (GIANT) (NCT04233866)
    Phase 2
    ECOG-ACRIN Cancer Research Group
    Active, not recruiting
    Last update posted :
    12/28/2023
    Initiation :
    08/26/2020
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    IL6 • UGT1A1
    |
    UGT1A1*1*1
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • fluorouracil topical • liposomal gemcitabine (FF-10832)
    NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer (NCT04005339)
    Phase 2
    Georgetown University
    Recruiting
    Last update posted :
    12/22/2023
    Initiation :
    07/29/2019
    Primary completion :
    05/30/2024
    Completion :
    07/31/2024
    CD4
    |
    5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma (NEO-Nal- IRI) (NCT03483038)
    Phase 2
    University of Florida
    Active, not recruiting
    Last update posted :
    11/18/2023
    Initiation :
    12/13/2018
    Primary completion :
    09/16/2023
    Completion :
    12/01/2024
    UGT1A1
    |
    UGT1A1*28 • UGT1A1*1*1
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma (NCI-2019-07966) (NCT04150640)
    Phase 2
    University of Wisconsin, Madison
    Recruiting
    Last update posted :
    11/01/2023
    Initiation :
    07/13/2020
    Primary completion :
    12/01/2025
    Completion :
    12/01/2026
    HER-2 • PD-L1
    |
    HER-2 positive • HER-2 negative
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Herceptin (trastuzumab) • 5-fluorouracil • Onivyde (nanoliposomal irinotecan)
    Combination Liposomal Irinotecan and Pembrolizumab For Triple-Negative Breast Cancer (TNBC) With Brain Metastases (BM) (NCT05255666)
    Phase 2
    Washington University School of Medicine
    Withdrawn
    Last update posted :
    07/11/2023
    Initiation :
    07/31/2023
    Primary completion :
    01/31/2027
    Completion :
    01/31/2030
    HER-2 • ER
    |
    HER-2 negative
    |
    Keytruda (pembrolizumab) • Onivyde (nanoliposomal irinotecan)
    Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer . (NCT05927857)
    Phase 1/2
    National Health Research Institutes, Taiwan
    Not yet recruiting
    Last update posted :
    06/30/2023
    Initiation :
    09/01/2023
    Primary completion :
    08/31/2025
    Completion :
    12/31/2025
    HER-2
    |
    Cyramza (ramucirumab) • Lonsurf (trifluridine/tipiracil) • Onivyde (nanoliposomal irinotecan)
    Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma (NCT02022644)
    Phase 1
    University of California, San Francisco
    Completed
    Last update posted :
    06/29/2023
    Initiation :
    10/23/2014
    Primary completion :
    12/31/2020
    Completion :
    05/31/2023
    UGT1A1
    |
    UGT1A1*1*1
    |
    Onivyde (nanoliposomal irinotecan)
    Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer (NCT05251038)
    Phase 1/2
    Devalingam Mahalingam
    Withdrawn
    Last update posted :
    05/11/2023
    Initiation :
    09/13/2022
    Primary completion :
    01/31/2023
    Completion :
    01/31/2023
    KRAS
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    gemcitabine • 5-fluorouracil • Lumakras (sotorasib) • albumin-bound paclitaxel • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    Nanoliposomal Irinotecan in Head & Neck and Esophagus After Prior Platinum-based Chemotherapy or Chemoradiotherapy (T2317) (NCT03712397)
    Phase 2
    National Health Research Institutes, Taiwan
    Completed
    Last update posted :
    04/11/2023
    Initiation :
    12/24/2018
    Primary completion :
    12/31/2022
    Completion :
    12/31/2022
    UGT1A1 • UGT1A9
    |
    UGT1A1*1*1
    |
    5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer (LyRICX) (NCT03764553)
    Phase 2
    Academisch Medisch Centrum - Universiteit van A...
    Recruiting
    Last update posted :
    12/16/2022
    Initiation :
    05/01/2019
    Primary completion :
    08/01/2024
    Completion :
    08/01/2024
    HER-2
    |
    HER-2 positive • HER-2 negative
    |
    carboplatin • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    Liposomal Irinotecan Plus 5-FU / LV Combined With Paricalcitol in Patients With Advanced Pancreatic Cancer Progressed on Gemcitabine-based Therapy (NCT03883919)
    Phase 1
    Washington University School of Medicine
    Completed
    Last update posted :
    10/05/2022
    Initiation :
    07/11/2019
    Primary completion :
    03/23/2021
    Completion :
    07/02/2022
    CA 19-9
    |
    gemcitabine • 5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    Study of Anti-CEA CAR-T + Chemotherapy VS Chemotherapy Alone in Patients With CEA+Pancreatic Cancer & Liver Metastases (NCT04037241)
    Phase 2b
    Sorrento Therapeutics, Inc.
    Withdrawn
    Last update posted :
    04/01/2022
    Initiation :
    11/01/2021
    Primary completion :
    01/01/2022
    Completion :
    01/01/2022
    CEACAM5
    |
    CEACAM5 expression
    |
    gemcitabine • 5-fluorouracil • capecitabine • albumin-bound paclitaxel • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • gene-modified anti-CEA T cells
    SGT-53 in Children With Recurrent or Progressive CNS Malignancies (NCT03554707)
    Phase 1
    SynerGene Therapeutics, Inc.
    Not yet recruiting
    Last update posted :
    02/08/2022
    Initiation :
    06/01/2022
    Primary completion :
    12/01/2023
    Completion :
    12/01/2024
    MGMT • MDM2 • CDKN1A
    |
    ATRX mutation • MDM2 mutation
    |
    Avastin (bevacizumab) • temozolomide • irinotecan • Onivyde (nanoliposomal irinotecan) • SGT-53
    Phase I and Pharmacokinetic Study of Biweekly PEP02 in mCRC Refractory to 1st-line Oxaliplatin Base Therapy (NCT00940758)
    Phase 1
    PharmaEngine
    Completed
    Last update posted :
    04/06/2017
    Initiation :
    06/01/2009
    Primary completion :
    05/01/2012
    Completion :
    06/01/2014
    UGT1A1
    |
    UGT1A1*1*1
    |
    oxaliplatin • irinotecan • Onivyde (nanoliposomal irinotecan)
    Evaluation of MM-151 + Nal-IRI + 5-FU + Leucovorin in RAS/RAF Wild-type Metastatic Colorectal Cancer (NCT02785068)
    Phase 1/2
    Merrimack Pharmaceuticals
    Withdrawn
    Last update posted :
    01/11/2017
    Initiation :
    07/01/2016
    Primary completion :
    05/01/2018
    Completion :
    10/01/2018
    EGFR • KRAS • BRAF
    |
    KRAS wild-type • BRAF wild-type • NRAS wild-type
    |
    5-fluorouracil • irinotecan • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • MM-151