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  1. Artikel ; Online: Stereotactic body radiotherapy plus rucosopasem in locally advanced or borderline resectable pancreatic cancer: GRECO-2 phase II study design.

    Hoffe, Sarah E / Aguilera, Todd A / Parikh, Parag J / Ghaly, Maged M / Herman, Joseph M / Caster, Joseph M / Kim, Dae Won / Costello, James / Malafa, Mokenge P / Moser, Elizabeth C / Kennedy, Eugene P / Terry, Kara / Kurman, Michael

    Future oncology (London, England)

    2024  Band 20, Heft 8, Seite(n) 437–446

    Abstract: Ablative doses of stereotactic body radiotherapy (SBRT) may improve pancreatic cancer outcomes but may carry greater potential for gastrointestinal toxicity. Rucosopasem, an investigational selective dismutase mimetic that converts superoxide to hydrogen ...

    Abstract Ablative doses of stereotactic body radiotherapy (SBRT) may improve pancreatic cancer outcomes but may carry greater potential for gastrointestinal toxicity. Rucosopasem, an investigational selective dismutase mimetic that converts superoxide to hydrogen peroxide, can potentially increase tumor control of SBRT without compromising safety. GRECO-2 is a phase II, multicenter, randomized, double-blind, placebo-controlled trial of rucosopasem in combination with SBRT in locally advanced or borderline resectable pancreatic cancer. Patients will be randomized to rucosopasem 100 mg or placebo via intravenous infusion over 15 min, before each SBRT fraction (5 × 10 Gy). The primary end point is overall survival. Secondary end points include progression-free survival, locoregional control, time to metastasis, surgical resection rate, best overall response, in-field local response and acute and long-term toxicity.
    Mesh-Begriff(e) Humans ; Adenocarcinoma ; Clinical Trials, Phase II as Topic ; Dose Fractionation, Radiation ; Multicenter Studies as Topic ; Pancreatic Neoplasms/diagnosis ; Pancreatic Neoplasms/radiotherapy ; Pancreatic Neoplasms/drug therapy ; Radiosurgery/adverse effects ; Randomized Controlled Trials as Topic
    Sprache Englisch
    Erscheinungsdatum 2024-01-24
    Erscheinungsland England
    Dokumenttyp Clinical Trial Protocol ; Journal Article
    ZDB-ID 2274956-1
    ISSN 1744-8301 ; 1479-6694
    ISSN (online) 1744-8301
    ISSN 1479-6694
    DOI 10.2217/fon-2022-1219
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel ; Online: A phase 1 study of the irreversible FLT3 inhibitor FF-10101 in relapsed or refractory acute myeloid leukemia.

    Levis, Mark / Perl, Alexander / Schiller, Gary / Fathi, Amir T / Roboz, Gail / Wang, Eunice S / Altman, Jessica / Rajkhowa, Trivikram / Ando, Makoto / Suzuki, Takeaki / Subach, Ruth Ann / Maier, Gary / Madden, Timothy / Johansen, Mary / Cheung, Kin / Kurman, Michael / Smith, Catherine

    Blood advances

    2024  Band 8, Heft 10, Seite(n) 2527–2535

    Abstract: Abstract: FLT3 tyrosine kinase inhibitors (TKIs) have clinical efficacy for patients with FLT3-mutated AML (acute myeloid leukemia), but their impact is limited by resistance in the setting of monotherapy and by tolerability problems when used in ... ...

    Abstract Abstract: FLT3 tyrosine kinase inhibitors (TKIs) have clinical efficacy for patients with FLT3-mutated AML (acute myeloid leukemia), but their impact is limited by resistance in the setting of monotherapy and by tolerability problems when used in combination therapies. FF-10101 is a novel compound that covalently binds to a cysteine residue near the active site of FLT3, irreversibly inhibiting receptor signaling. It is effective against most FLT3 activating mutations, and, unlike other inhibitors, is minimally vulnerable to resistance induced by FLT3 ligand. We conducted a phase 1 dose escalation study of oral FF-10101 in patients with relapsed and/or refractory AML, the majority of whom harbored FLT3-activating mutations and/or had prior exposure to FLT3 inhibitors. Fifty-four participants enrolled in cohorts receiving doses ranging from 10 to 225 mg per day and 50 to 100 mg twice daily (BID). The dose limiting toxicities were diarrhea and QT prolongation. Among 40 response-evaluable participants, the composite complete response rate was 10%, and the overall response rate (including partial responses) was 12.5%, including patients who had progressed on gilteritinib. Overall, 56% of participants had prior exposure to FLT3 inhibitors. The recommended phase 2 dose was 75 mg BID. FF-10101 potentially represents a next-generation advance in the management of FLT3-mutated AML. This trial was registered at www.ClinicalTrials.gov as #NCT03194685.
    Mesh-Begriff(e) Humans ; fms-Like Tyrosine Kinase 3/antagonists & inhibitors ; Leukemia, Myeloid, Acute/drug therapy ; Middle Aged ; Female ; Male ; Adult ; Aged ; Protein Kinase Inhibitors/therapeutic use ; Protein Kinase Inhibitors/pharmacology ; Recurrence ; Mutation ; Treatment Outcome ; Drug Resistance, Neoplasm/drug effects ; Aged, 80 and over ; Antineoplastic Agents/therapeutic use ; Antineoplastic Agents/pharmacology ; Antineoplastic Agents/adverse effects ; Young Adult
    Chemische Substanzen FLT3 protein, human
    Sprache Englisch
    Erscheinungsdatum 2024-03-19
    Erscheinungsland United States
    Dokumenttyp Journal Article ; Clinical Trial, Phase I
    ZDB-ID 2915908-8
    ISSN 2473-9537 ; 2473-9529
    ISSN (online) 2473-9537
    ISSN 2473-9529
    DOI 10.1182/bloodadvances.2023010619
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel ; Online: Results of a Phase 1/2a dose-escalation study of FF-10501-01, an IMPDH inhibitor, in patients with acute myeloid leukemia or myelodysplastic syndromes.

    Garcia-Manero, Guillermo / Pemmaraju, Naveen / Alvarado, Yesid / Naqvi, Kiran / Ravandi, Farhad / Jabbour, Elias / De Lumpa, Ricardo / Kantarjian, Hagop / Advani, Anjali / Mukherjee, Sudipto / Gerds, Aaron / Carraway, Hetty E / Nazha, Aziz / Iwamura, Hiroyuki / Murase, Motohiko / Bavisotto, Linda / Kurman, Michael / Maier, Gary / Johansen, Mary /
    Sekeres, Mikkael A

    Leukemia & lymphoma

    2020  Band 61, Heft 8, Seite(n) 1943–1953

    Abstract: FF-10501-01 potently inhibits inosine-5-monophosphate dehydrogenase (IMPDH), inducing anti-proliferative and pro-apoptotic effects in acute myeloid leukemia (AML) human cell lines resistant to hypomethylating agents. In this Phase 1/2a study, Phase 1 ... ...

    Abstract FF-10501-01 potently inhibits inosine-5-monophosphate dehydrogenase (IMPDH), inducing anti-proliferative and pro-apoptotic effects in acute myeloid leukemia (AML) human cell lines resistant to hypomethylating agents. In this Phase 1/2a study, Phase 1 enrolled 38 patients with relapsed/refractory AML (
    Mesh-Begriff(e) Enzyme Inhibitors/adverse effects ; Humans ; IMP Dehydrogenase ; Leukemia, Myeloid, Acute/drug therapy ; Myelodysplastic Syndromes/drug therapy
    Chemische Substanzen Enzyme Inhibitors ; IMP Dehydrogenase (EC 1.1.1.205)
    Sprache Englisch
    Erscheinungsdatum 2020-04-07
    Erscheinungsland United States
    Dokumenttyp Clinical Trial, Phase I ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 1042374-6
    ISSN 1029-2403 ; 1042-8194
    ISSN (online) 1029-2403
    ISSN 1042-8194
    DOI 10.1080/10428194.2020.1747065
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  4. Artikel ; Online: Mogamulizumab

    Phillips, Adrienne A / Fields, Paul A / Hermine, Olivier / Ramos, Juan C / Beltran, Brady E / Pereira, Juliana / Wandroo, Farooq / Feldman, Tatyana / Taylor, Graham P / Sawas, Ahmed / Humphrey, Jeffrey / Kurman, Michael / Moriya, Junji / Dwyer, Karen / Leoni, Mollie / Conlon, Kevin / Cook, Lucy / Gonsky, Jason / Horwitz, Steven M

    Haematologica

    2018  Band 104, Heft 5, Seite(n) 993–1003

    Abstract: Mogamulizumab, a humanized defucosylated anti-C-C chemokine receptor 4 monoclonal antibody, has been approved in Japan for the treatment of C-C chemokine receptor 4-positive adult T-cell leukemia/lymphoma (ATL). This phase II study evaluated efficacy and ...

    Abstract Mogamulizumab, a humanized defucosylated anti-C-C chemokine receptor 4 monoclonal antibody, has been approved in Japan for the treatment of C-C chemokine receptor 4-positive adult T-cell leukemia/lymphoma (ATL). This phase II study evaluated efficacy and safety of mogamulizumab in ATL patients with acute, lymphoma, and chronic subtypes with relapsed/refractory, aggressive disease in the US, Europe, and Latin America. With stratification by subtype, patients were randomized 2:1 to intravenous mogamulizumab 1.0 mg/kg once weekly for 4 weeks and biweekly thereafter (n=47) or investigator's choice of chemotherapy (n=24). The primary end point was confirmed overall response rate (cORR) confirmed on a subsequent assessment at 8 weeks by blinded independent review. ORR was 11% (95%CI: 4-23%) and 0% (95%CI: 0-14%) in the mogamulizumab and chemotherapy arms, respectively. Best response was 28% and 8% in the respective arms. The observed hazard ratio for progression-free survival was 0.71 (95%CI: 0.41-1.21) and, after
    Mesh-Begriff(e) Adult ; Aged ; Aged, 80 and over ; Aminopterin/administration & dosage ; Aminopterin/analogs & derivatives ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Cisplatin/administration & dosage ; Cytarabine/administration & dosage ; Deoxycytidine/administration & dosage ; Deoxycytidine/analogs & derivatives ; Dexamethasone/administration & dosage ; Drug Resistance, Neoplasm/drug effects ; Female ; Follow-Up Studies ; Humans ; International Agencies ; Leukemia-Lymphoma, Adult T-Cell/drug therapy ; Leukemia-Lymphoma, Adult T-Cell/pathology ; Male ; Middle Aged ; Neoplasm Recurrence, Local/drug therapy ; Neoplasm Recurrence, Local/pathology ; Oxaliplatin/administration & dosage ; Prognosis ; Retrospective Studies ; Salvage Therapy ; Survival Rate ; Young Adult
    Chemische Substanzen 10-propargyl-10-deazaaminopterin ; Antibodies, Monoclonal, Humanized ; Cytarabine (04079A1RDZ) ; Oxaliplatin (04ZR38536J) ; Deoxycytidine (0W860991D6) ; Dexamethasone (7S5I7G3JQL) ; gemcitabine (B76N6SBZ8R) ; Aminopterin (JYB41CTM2Q) ; Cisplatin (Q20Q21Q62J) ; mogamulizumab (YI437801BE)
    Sprache Englisch
    Erscheinungsdatum 2018-12-20
    Erscheinungsland Italy
    Dokumenttyp Clinical Trial, Phase II ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2333-4
    ISSN 1592-8721 ; 0017-6567 ; 0390-6078
    ISSN (online) 1592-8721
    ISSN 0017-6567 ; 0390-6078
    DOI 10.3324/haematol.2018.205096
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  5. Artikel ; Online: Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma.

    Duvic, Madeleine / Pinter-Brown, Lauren C / Foss, Francine M / Sokol, Lubomir / Jorgensen, Jeffrey L / Challagundla, Pramoda / Dwyer, Karen M / Zhang, Xiaoping / Kurman, Michael R / Ballerini, Rocco / Liu, Li / Kim, Youn H

    Blood

    2015  Band 125, Heft 12, Seite(n) 1883–1889

    Abstract: This phase 1/2 study evaluated the efficacy of mogamulizumab, a defucosylated, humanized, anti-CC chemokine receptor 4 monoclonal antibody, in 41 pretreated patients with cutaneous T-cell lymphoma. No dose-limiting toxicity was observed and the maximum ... ...

    Abstract This phase 1/2 study evaluated the efficacy of mogamulizumab, a defucosylated, humanized, anti-CC chemokine receptor 4 monoclonal antibody, in 41 pretreated patients with cutaneous T-cell lymphoma. No dose-limiting toxicity was observed and the maximum tolerated dose was not reached in phase 1 after IV infusion of mogamulizumab (0.1, 0.3, and 1.0 mg/kg) once weekly for 4 weeks followed by a 2-week observation. In phase 2, patients were dosed with 1.0 mg/kg mogamulizumab according to the same schedule for the first course followed by infusion every 2 weeks during subsequent courses until disease progression. The most frequent treatment-emergent adverse events were nausea (31.0%), chills (23.8%), headache (21.4%), and infusion-related reaction (21.4%); the majority of events were grade 1/2. There were no significant hematologic effects. Among 38 evaluable patients, the overall response rate was 36.8%: 47.1% in Sézary syndrome (n = 17) and 28.6% in mycosis fungoides (n = 21). Eighteen of 19 (94.7%) patients with ≥B1 blood involvement had a response in blood, including 11 complete responses. Given the safety and efficacy of mogamulizumab, phase 3 investigation of mogamulizumab is warranted in cutaneous T-cell lymphoma patients. This trial was registered at www.clinicaltrials.gov as #NCT00888927.
    Mesh-Begriff(e) Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/therapeutic use ; Drug Administration Schedule ; Female ; Humans ; Lymphoma, T-Cell, Cutaneous/immunology ; Lymphoma, T-Cell, Cutaneous/therapy ; Male ; Maximum Tolerated Dose ; Middle Aged ; Mycosis Fungoides/immunology ; Mycosis Fungoides/therapy ; Prognosis ; Receptors, CCR4/immunology ; Sezary Syndrome/immunology ; Sezary Syndrome/therapy ; Treatment Outcome
    Chemische Substanzen Antibodies, Monoclonal, Humanized ; CCR4 protein, human ; Receptors, CCR4 ; mogamulizumab (YI437801BE)
    Sprache Englisch
    Erscheinungsdatum 2015-01-20
    Erscheinungsland United States
    Dokumenttyp Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ZDB-ID 80069-7
    ISSN 1528-0020 ; 0006-4971
    ISSN (online) 1528-0020
    ISSN 0006-4971
    DOI 10.1182/blood-2014-09-600924
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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