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Sökning: WFRF:(Nygren Magnus) > (2015-2019) > First-in-human, pha...

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00005155naa a2200565 4500
001oai:DiVA.org:uu-270433
003SwePub
008151228s2015 | |||||||||||000 ||eng|
009oai:prod.swepub.kib.ki.se:132467009
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-2704332 URI
0247 a https://doi.org/10.1007/s10637-015-0299-22 DOI
0247 a http://kipublications.ki.se/Default.aspx?queryparsed=id:1324670092 URI
040 a (SwePub)uud (SwePub)ki
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Berglund, Åkeu Uppsala universitet,Experimentell och klinisk onkologi4 aut0 (Swepub:uu)akebergl
2451 0a First-in-human, phase I/IIa clinical study of the peptidase potentiated alkylator melflufen administered every three weeks to patients with advanced solid tumor malignancies
264 c 2015-11-10
264 1b Springer Science and Business Media LLC,c 2015
338 a print2 rdacarrier
520 a Purpose Melflufen (melphalan flufenamide, previously designated J1) is an optimized and targeted derivative of melphalan, hydrolyzed by aminopeptidases overexpressed in tumor cells resulting in selective release and trapping of melphalan, and enhanced activity in preclinical models. Methods This was a prospective, single-armed, open-label, first-in-human, dose-finding phase I/IIa study in 45 adult patients with advanced and progressive solid tumors without standard treatment options. Most common tumor types were ovarian carcinoma (n = 20) and non-small-cell lung cancer (NSCLC, n = 11). Results In the dose-escalating phase I part of the study, seven patients were treated with increasing fixed doses of melflufen (25-130 mg) Q3W. In the subsequent phase IIa part, 38 patients received in total 115 cycles of therapy at doses of 30-75 mg. No dose-limiting toxicities (DLTs) were observed at 25 and 50 mg; at higher doses DLTs were reversible neutropenias and thrombocytopenias, particularly evident in heavily pretreated patients, and the recommended phase II dose (RPTD) was set to 50 mg. Response Evaluation Criteria In Solid Tumors (RECIST) evaluation after 3 cycles of therapy (27 patients) showed partial response in one (ovarian cancer), and stable disease in 18 patients. One NSCLC patient received nine cycles of melflufen and progressed after 7 months of therapy. Conclusions In conclusion, melflufen can safely be given to cancer patients, and the toxicity profile was as expected for alkylating agents; RPTD is 50 mg Q3W. Reversible and manageable bone marrow suppression was identified as a DLT. Clinical activity is suggested in ovarian cancer, but modest activity in treatment of refractory NSCLC.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
650 7a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Farmakologi och toxikologi0 (SwePub)301022 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Pharmacology and Toxicology0 (SwePub)301022 hsv//eng
653 a Melphalan flufenamide
653 a Melflufen
653 a J1
7001 a Ullen, Andersu Karolinska Institutet4 aut
7001 a Lisyanskaya, Allau City Clin Oncol Ctr, St Petersburg State Healthcare Inst, St Petersburg, Russia.4 aut
7001 a Orlov, Sergeyu St Petersburg State Med Univ, State Educ Inst Higher Profess Educ, St Petersburg, Russia.4 aut
7001 a Hagberg, Hansu Uppsala universitet,Experimentell och klinisk onkologi4 aut0 (Swepub:uu)hanshagb
7001 a Tholander, Bengtu Uppsala universitet,Experimentell och klinisk onkologi4 aut0 (Swepub:uu)betho227
7001 a Lewensohn, Rolfu Karolinska Institutet4 aut
7001 a Nygren, Peteru Uppsala universitet,Experimentell och klinisk onkologi4 aut0 (Swepub:uu)peterng
7001 a Spira, Jacku Oncopeptides AB, Stockholm, Sweden.4 aut
7001 a Harmenberg, Johanu Oncopeptides AB, Stockholm, Sweden.4 aut
7001 a Jerling, Markusu Oncopeptides AB, Stockholm, Sweden.4 aut
7001 a Alvfors, Carinau Uppsala universitet,Uppsala kliniska forskningscentrum (UCR)4 aut0 (Swepub:uu)carialvf
7001 a Ringbom, Magnusu Uppsala universitet,Uppsala kliniska forskningscentrum (UCR)4 aut0 (Swepub:uu)magri896
7001 a Nordstrom, Evau Oncopeptides AB, Stockholm, Sweden.4 aut
7001 a Soderlind, Karinu Oncopeptides AB, Stockholm, Sweden.4 aut
7001 a Gullbo, Joachimu Uppsala universitet,Experimentell och klinisk onkologi4 aut0 (Swepub:uu)joacgull
7102 a Uppsala universitetb Experimentell och klinisk onkologi4 org
7730 t Investigational new drugsd : Springer Science and Business Media LLCg 33:6, s. 1232-1241q 33:6<1232-1241x 0167-6997x 1573-0646
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-270433
8564 8u https://doi.org/10.1007/s10637-015-0299-2
8564 8u http://kipublications.ki.se/Default.aspx?queryparsed=id:132467009

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