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    DRUG:

    Myocet (non-pegylated liposomal doxorubicin)

    i
    Other names: NSC 620212, TLC D99, TLC Dox99, DX-GP
    Company:
    Sopherion, Teva
    Drug class:
    Topoisomerase II inhibitor
    Related drugs:
    1m
    A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced, Recurrent Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer (clinicaltrials.gov)
    P2, N=38, Not yet recruiting, OHSU Knight Cancer Institute
    New P2 trial • Metastases
    |
    Lynparza (olaparib) • Tagrisso (osimertinib) • carboplatin • gefitinib • gemcitabine • paclitaxel • temozolomide • tamoxifen • Verzenio (abemaciclib) • pemetrexed • fulvestrant • letrozole • pegylated liposomal doxorubicin • exemestane • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    2ms
    NRG-GY004: Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P3, N=579, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Aug 2024 --> Aug 2025
    Trial completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • BRCA1 mutation • BRCA mutation
    |
    Lynparza (olaparib) • carboplatin • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    3ms
    NRG-GY023: Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents (clinicaltrials.gov)
    P2, N=120, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2025 --> Jun 2025
    Trial completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    Avastin (bevacizumab) • Lynparza (olaparib) • Imfinzi (durvalumab) • paclitaxel • pegylated liposomal doxorubicin • topotecan • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    3ms
    Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=31, Not yet recruiting, Roswell Park Cancer Institute | Trial completion date: Jun 2028 --> Sep 2028 | Initiation date: Jun 2024 --> Sep 2024 | Trial primary completion date: Jun 2028 --> Sep 2028
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    tamoxifen • pegylated liposomal doxorubicin • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    4ms
    COCOS: Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer (clinicaltrials.gov)
    P2/3, N=587, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2024 --> Jun 2025
    Trial completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    Lynparza (olaparib) • paclitaxel • pegylated liposomal doxorubicin • topotecan • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    5ms
    Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7) (clinicaltrials.gov)
    P3, N=456, Active, not recruiting, Mural Oncology, Inc | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Keytruda (pembrolizumab) • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • nemvaleukin alfa (ALKS 4230)
    6ms
    Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer (clinicaltrials.gov)
    P2, N=31, Not yet recruiting, Roswell Park Cancer Institute
    New P2 trial • Metastases
    |
    tamoxifen • pegylated liposomal doxorubicin • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    7ms
    Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7) (clinicaltrials.gov)
    P3, N=448, Recruiting, Mural Oncology, Inc | Active, not recruiting --> Recruiting | Trial completion date: Dec 2026 --> May 2027 | Trial primary completion date: Dec 2025 --> May 2026
    Enrollment open • Trial completion date • Trial primary completion date • Combination therapy
    |
    Keytruda (pembrolizumab) • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • nemvaleukin alfa (ALKS 4230)
    7ms
    Phase II randomized trial comparing metronomic anthracycline-containing chemotherapy versus standard schedule in untreated HER2 negative advanced breast cancer: activity and quality of life results of the GOIM 21003 trial. (PubMed, Breast)
    First line metronomic chemotherapy for HER2 negative ABC had similar clinical activity and quite better tolerability than standard schedule and could be considered a further treatment option when chemotherapy is indicated.
    P2 data • Journal • HEOR • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    cyclophosphamide • Myocet (non-pegylated liposomal doxorubicin)
    7ms
    Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer (clinicaltrials.gov)
    P1, N=40, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Surgery
    |
    cisplatin • carboplatin • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    8ms
    Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7) (clinicaltrials.gov)
    P3, N=376, Active, not recruiting, Mural Oncology, Inc | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Keytruda (pembrolizumab) • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • nemvaleukin alfa (ALKS 4230)
    10ms
    NRG-GY023: Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents (clinicaltrials.gov)
    P2, N=149, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Jan 2025 | Trial primary completion date: Dec 2023 --> Jan 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    Avastin (bevacizumab) • Lynparza (olaparib) • Imfinzi (durvalumab) • paclitaxel • pegylated liposomal doxorubicin • topotecan • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    11ms
    ETCTN 10563: Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma (clinicaltrials.gov)
    P1, N=36, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting | Initiation date: May 2023 --> Feb 2024
    Enrollment open • Trial initiation date
    |
    pegylated liposomal doxorubicin • Myocet (non-pegylated liposomal doxorubicin) • peposertib (M3814) • Duomeisu (pegylated liposomal doxorubicin)
    12ms
    NRG-GY023: Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents (clinicaltrials.gov)
    P2, N=164, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2024 --> Dec 2023
    Trial completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    Avastin (bevacizumab) • Lynparza (olaparib) • Imfinzi (durvalumab) • paclitaxel • pegylated liposomal doxorubicin • topotecan • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    1year
    NRG-GY023: Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents (clinicaltrials.gov)
    P2, N=149, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Nov 2024
    Trial completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    Avastin (bevacizumab) • Lynparza (olaparib) • Imfinzi (durvalumab) • paclitaxel • pegylated liposomal doxorubicin • topotecan • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    1year
    Cost-effectiveness analysis of RAD51 functional biomarker for platinum sensitivity in the GeparSixto trial (SABCS 2023)
    The pharmacological costs were calculated following treatment protocol of GeparSixto where TNBC patients received neoadjuvant paclitaxel plus Myocet®-nonpegylated liposomal doxorubicin (PM) or PM plus carboplatin (PMCb), both arms including bevacizumab. The most efficient scenarios are the functional RAD51 test and all comers. Both tBRCA1/2 and genomic HRD by Myriad Mychoice® scenarios provide worse health outcomes at a higher cost, based on the data of the GeparSixto trial. This study highlights the potential overall benefit of functional HRD biomarkers to predict PARPi sensitivity.
    HEOR • Cost-effectiveness • Cost effectiveness • PARP Biomarker • BRCA Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • RAD51 (RAD51 Homolog A)
    |
    BRCA2 mutation • BRCA1 mutation • RAD51 mutation
    |
    Myriad myChoice® CDx
    |
    Avastin (bevacizumab) • carboplatin • paclitaxel • Myocet (non-pegylated liposomal doxorubicin)
    1year
    Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer (clinicaltrials.gov)
    P2/3, N=260, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2023 --> Oct 2024
    Trial completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    Mekinist (trametinib) • paclitaxel • letrozole • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin) • Soltamox (tamoxifen citrate)
    1year
    Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P3, N=579, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Aug 2024
    Trial completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • BRCA1 mutation • BRCA mutation
    |
    Lynparza (olaparib) • carboplatin • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    1year
    Non-pegylated liposomal doxorubicin in older adjuvant early breast cancer patients: cardiac safety analysis and final results of the COLTONE study. (PubMed, Clin Exp Med)
    The combination including NPL-DOX in elderly patients revealed low rate of cardiac toxic effects. Comparative trials are encouraged.
    Journal
    |
    paclitaxel • cyclophosphamide • Myocet (non-pegylated liposomal doxorubicin)
    over1year
    Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P2/3, N=443, Active, not recruiting, National Cancer Institute (NCI) | Trial primary completion date: Jun 2024 --> May 2023
    Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • pegylated liposomal doxorubicin • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    over1year
    A Fondazione Italiana Linfomi cohort study of R-COMP vs R-CHOP in older patients with diffuse large B-cell lymphoma. (PubMed, Blood Adv)
    Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is the most commonly used regimen for the upfront treatment of diffuse large B-cell lymphoma (DLBCL)...Substituting doxorubicin with non-PEGylated liposomal doxorubicin (R-COMP) may reduce the risk of cardiac events, but its efficacy has never been demonstrated in prospective trials...Our study suggests that R-COMP represents a potentially curative treatment for EPI intermediate-/high-risk older patients, even in the presence of a baseline cardiopathy. R-CHOP is confirmed as the standard therapy for patients at low risk.
    Journal
    |
    Rituxan (rituximab) • cyclophosphamide • vincristine • prednisone • Myocet (non-pegylated liposomal doxorubicin)
    over1year
    Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy (clinicaltrials.gov)
    P2, N=0, Withdrawn, National Cancer Institute (NCI) | N=96 --> 0 | Trial completion date: Jul 2024 --> Mar 2023 | Suspended --> Withdrawn | Trial primary completion date: Jul 2024 --> Mar 2023
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    BRCA2 mutation • HRD
    |
    Lynparza (olaparib) • paclitaxel • Aliqopa (copanlisib) • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    over1year
    Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P2/3, N=444, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • pegylated liposomal doxorubicin • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    over1year
    COCOS: Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer (clinicaltrials.gov)
    P2/3, N=562, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    BRCA2 mutation • BRCA1 mutation • BRCA mutation
    |
    Lynparza (olaparib) • paclitaxel • pegylated liposomal doxorubicin • topotecan • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    over1year
    Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma (clinicaltrials.gov)
    P1, N=36, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension • Combination therapy • Metastases
    |
    pegylated liposomal doxorubicin • Myocet (non-pegylated liposomal doxorubicin) • peposertib (M3814) • Duomeisu (pegylated liposomal doxorubicin)
    over1year
    Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer (clinicaltrials.gov)
    P1, N=52, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2023 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog)
    |
    PIK3CA mutation
    |
    Avastin (bevacizumab) • oxaliplatin • Torisel (temsirolimus) • pegylated liposomal doxorubicin • leucovorin calcium • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin) • fluorouracil topical
    over1year
    Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma (clinicaltrials.gov)
    P1, N=36, Recruiting, National Cancer Institute (NCI) | N=66 --> 36
    Enrollment change • Combination therapy • Metastases
    |
    pegylated liposomal doxorubicin • Myocet (non-pegylated liposomal doxorubicin) • peposertib (M3814) • Duomeisu (pegylated liposomal doxorubicin)
    over1year
    Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma (clinicaltrials.gov)
    P1, N=66, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Trial completion date: Apr 2023 --> May 2025 | Trial primary completion date: Apr 2023 --> May 2025
    Enrollment open • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    pegylated liposomal doxorubicin • Myocet (non-pegylated liposomal doxorubicin) • peposertib (M3814) • Duomeisu (pegylated liposomal doxorubicin)
    over1year
    Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
    P2, N=13, Completed, Mayo Clinic | Recruiting --> Completed | N=240 --> 13
    Trial completion • Enrollment change
    |
    Avastin (bevacizumab) • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    over1year
    Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents (clinicaltrials.gov)
    P2, N=164, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    Avastin (bevacizumab) • Lynparza (olaparib) • Imfinzi (durvalumab) • paclitaxel • pegylated liposomal doxorubicin • topotecan • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    over1year
    A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Therapy in Elderly Patients With Low Response (clinicaltrials.gov)
    P3, N=80, Active, not recruiting, West German Study Group | Unknown status --> Active, not recruiting | Trial completion date: Oct 2020 --> Oct 2024
    Enrollment closed • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    paclitaxel • doxorubicin hydrochloride • cyclophosphamide • Myocet (non-pegylated liposomal doxorubicin)
    over1year
    Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy (clinicaltrials.gov)
    P2, N=96, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    BRCA2 mutation • HRD
    |
    Lynparza (olaparib) • paclitaxel • Aliqopa (copanlisib) • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    almost2years
    CD33+ TARGETING, CONSOLIDATIVE HSCT AND INTEGRATION OF MIDOSTAURIN IN FLT3 POSITIVE AML PEDIATRIC PATIENTS: A SINGLE CENTER EXPERIENCE (EBMT 2023)
    Gemtuzumab ozogamicin (GO) is an anti-CD33 monoclonal antibody approved by EMA in 2018 for the treatment of patients aged 15 years and above with previously untreated de novo CD33-positive AML, in combination with daunorubicin and cytarabine...Two additional cycles (Clofarabin-daunorubicin-Cytarabin and high dose Etoposide) were administered, without response. The patient then received additional treatment based on the association of GO, Doxorubicin, Aracytin and Midostaurin. Haploidentical HSCT with peripheral TCRalpha/beta-CD19 depleted cells from father was then performed in aplasia, preceded by a myeloablative conditioning regimen based on TBI-Melphalan...Additional treatment with Fludarabin-Aracytin-Myocet-G CSF could not prevent disease progression... GO integration into the FLT3-AML therapy before HSCT resulted in improved outcomes for pediatric patients with refractory AML. Combination of targeted inhibition of FLT3 and CD33 followed by allogeneic HSCT could be a promising therapeutic opportunity for refractory/relapsed pediatric AML.
    Clinical • IO biomarker
    |
    FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1) • CD19 (CD19 Molecule) • CD33 (CD33 Molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • CD7 (CD7 Molecule) • CD99 (CD99 Molecule)
    |
    FLT3-ITD mutation • CD33 positive • PTPRC expression • FLT3 positive
    |
    doxorubicin hydrochloride • etoposide IV • Rydapt (midostaurin) • Mylotarg (gemtuzumab ozogamicin) • daunorubicin • Vyxeos (cytarabine/daunorubicin liposomal formulation) • melphalan • Myocet (non-pegylated liposomal doxorubicin)
    almost2years
    Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents (clinicaltrials.gov)
    P2, N=164, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    Avastin (bevacizumab) • Lynparza (olaparib) • Imfinzi (durvalumab) • paclitaxel • pegylated liposomal doxorubicin • topotecan • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    almost2years
    Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer (clinicaltrials.gov)
    P2, N=29, Completed, University of Wisconsin, Madison | Active, not recruiting --> Completed | Trial completion date: Oct 2022 --> Feb 2022
    Trial completion • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    carboplatin • paclitaxel • cyclophosphamide • pegylated liposomal doxorubicin • Myocet (non-pegylated liposomal doxorubicin) • Neulasta (pegfilgrastim) • Neupogen (filgrastim)
    almost2years
    Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer (clinicaltrials.gov)
    P1, N=52, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog)
    |
    PIK3CA mutation
    |
    Avastin (bevacizumab) • oxaliplatin • Torisel (temsirolimus) • pegylated liposomal doxorubicin • leucovorin calcium • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin) • fluorouracil topical
    almost2years
    Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
    P3, N=579, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2022 --> Dec 2023
    Trial completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • BRCA1 mutation • BRCA mutation
    |
    Lynparza (olaparib) • carboplatin • gemcitabine • paclitaxel • pegylated liposomal doxorubicin • Recentin (cediranib) • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    2years
    Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy (clinicaltrials.gov)
    P2, N=96, Recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2022 --> Jul 2024 | Trial primary completion date: Sep 2022 --> Jul 2024
    Trial completion date • Trial primary completion date
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    BRCA2 mutation • HRD
    |
    Lynparza (olaparib) • paclitaxel • Aliqopa (copanlisib) • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin) • Duomeisu (pegylated liposomal doxorubicin)
    over2years
    Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy (clinicaltrials.gov)
    P2, N=96, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • MUC16 (Mucin 16, Cell Surface Associated)
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    BRCA2 mutation • HRD
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    Lynparza (olaparib) • paclitaxel • Aliqopa (copanlisib) • pegylated liposomal doxorubicin • topotecan • Myocet (non-pegylated liposomal doxorubicin)
    over2years
    Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer (clinicaltrials.gov)
    P1, N=52, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
    Trial completion date • Trial primary completion date
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    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog)
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    PIK3CA mutation
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    Avastin (bevacizumab) • oxaliplatin • Torisel (temsirolimus) • pegylated liposomal doxorubicin • leucovorin calcium • Myocet (non-pegylated liposomal doxorubicin) • fluorouracil topical
    over2years
    Final results from a phase III randomized clinical trial of adjuvant endocrine therapy ± chemotherapy in women ≥ 70 years old with ER+ HER2- breast cancer and a high genomic grade index: The Unicancer ASTER 70s trial. (ASCO 2022)
    Investigators chose between 3 CT regimens: 4 cycles of doxorubicin/cyclophosphamide, non-pegylated liposomal doxorubicin/cyclophosphamide or docetaxel/cyclophosphamide, given q3w with G-CSF. Standard ET consisted of 5 years of aromatase inhibitor, tamoxifen or a sequence based on tolerance... In this large phase III trial, we did not find a statistically significant OS benefit with the addition of CT to ET after surgery for ER+ HER2- BC with a high GGI. Analysis of the other outcome measures will be presented.
    Clinical • P3 data
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    HER-2 negative
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    tamoxifen • cyclophosphamide • Myocet (non-pegylated liposomal doxorubicin)
    over2years
    Non-pegylated liposomal doxorubicin plus cyclophosphamide as first-line therapy in elderly women with HER2 negative metastatic breast cancer. (PubMed, Clin Ter)
    Hematologic toxicity with neutropenia was the most frequent adverse event, but the treatment was well tolerated maintained a manageable cardiotoxicity. Non-pegylated liposomal doxorubicin may represent a valid therapeutic option in first-line for elderly patients with HER/2 negative MBC improving survival, anti-tumor response rate and de-creases cardiotoxicity.
    Observational data • Retrospective data • Journal
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
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    cyclophosphamide • Myocet (non-pegylated liposomal doxorubicin)