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A phase I study assessing the safety and pharmacokinetics of the thrombospondin-1-mimetic angiogenesis inhibitor ABT-510 with gemcitabine and cisplatin in patients with solid tumors.
- Source :
-
Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2006 Aug; Vol. 17 (8), pp. 1320-7. Date of Electronic Publication: 2006 May 25. - Publication Year :
- 2006
-
Abstract
- Background: The aim of the study was to determine the safety profile, pharmacokinetics and potential drug interactions of the angiogenesis inhibitor ABT-510 combined with gemcitabine-cisplatin chemotherapy in patients with solid tumors.<br />Patients and Methods: Patients with advanced solid tumors received gemcitabine 1250 mg/m2 intravenously (i.v.) on days 1 and 8 and cisplatin 80 mg/m2 on day 1 of a 3-week cycle in combination with ABT-510. ABT-510 was administered subcutaneously twice daily at doses of 50 mg or 100 mg. Plasma samples for pharmacokinetics were obtained on days 1 (gemcitabine, cisplatin as single agents), 15 (ABT-510 as single agent) and 22 (gemcitabine, cisplatin and ABT-510 as combination).<br />Results: Thirteen patients received ABT-510 as either 50 mg b.i.d. (seven patients) or 100 mg b.i.d. (six patients) in combination with gemcitabine-cisplatin. The most common reported adverse events reflected the known toxicity profile induced by gemcitabine-cisplatin without ABT-510. One episode of hemoptysis occurred in a patient with non-small-cell lung cancer (NSCLC) after 13 days of treatment. No clinically significant pharmacokinetic interactions between ABT-510, gemcitabine and platinum were observed. Three partial responses were observed in 12 evaluable patients (one head and neck cancer, one melanoma and one NSCLC).<br />Conclusions: Combining ABT-510 at doses of 50 mg and 100 mg with gemcitabine-cisplatin is feasible. Pharmacokinetic interactions were not observed and adding ABT-510 does not appear to increase toxicity.
- Subjects :
- Adult
Aged
Angiogenesis Inhibitors administration & dosage
Cisplatin administration & dosage
Deoxycytidine administration & dosage
Deoxycytidine analogs & derivatives
Drug Interactions
Female
Humans
Male
Middle Aged
Oligopeptides administration & dosage
Thrombospondin 1 chemistry
Thrombospondin 1 pharmacology
Gemcitabine
Angiogenesis Inhibitors adverse effects
Angiogenesis Inhibitors pharmacokinetics
Antineoplastic Combined Chemotherapy Protocols adverse effects
Antineoplastic Combined Chemotherapy Protocols pharmacokinetics
Neoplasms drug therapy
Oligopeptides adverse effects
Oligopeptides pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 0923-7534
- Volume :
- 17
- Issue :
- 8
- Database :
- MEDLINE
- Journal :
- Annals of oncology : official journal of the European Society for Medical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 16728485
- Full Text :
- https://doi.org/10.1093/annonc/mdl102