Details der Publikation - A phase I trial of SJG-136 (NSC#694501) in advanced solid tumors

A phase I trial of SJG-136 (NSC#694501) in advanced solid tumors

Purpose SJG-136 is a pyrrolobenzodiazepine dimer that forms DNA crosslinks and has demonstrated broad antitumor activity. We undertook this trial to determine the maximum-tolerated dose (MTD), toxicities and pharmacokinetic (PK) profile of SJG-136 in patients with an advanced solid tumor. Patients and methods In this phase I study, patients were treated with SJG-136 on days 1, 8 and 15 of a 28-day cycle. Dose levels studied were 10, 20, 40 and 60 μg/$ m^{2} $. PK parameters of SJG-136 were assessed following the intravenous administration of SJG-136 on days 1 and 15 of cycle 1. Results Twenty-one patients with advanced solid tumors were treated. Patients had a median of two prior chemotherapy regimens. Fatigue was dose-limiting with SJG-136 60 μg/$ m^{2} $/day administered on days 1, 8 and 15 of a 28-day cycle. Grade 3 thrombocytopenia and delayed onset liver toxicity were seen in one patient each. PK parameters of SJG-136 indicated dose-proportional increases in systemic exposure with increasing doses. No objective responses were seen. Conclusion For patients with advanced solid tumors, the MTD of SJG-136 is 40 μg/$ m^{2} $/day administered on days 1, 8 and 15 of a 28-day cycle. The major dose limiting toxicity was fatigue. Alternative dosing strategies are now being evaluated..

Medienart:	E-Artikel

Erscheinungsjahr:	2009
Erschienen:	2009

Enthalten in:	Zur Gesamtaufnahme - volume:65
Enthalten in:	Cancer chemotherapy and pharmacology - 65(2009), 5 vom: 12. Aug., Seite 833-838

Sprache:	Englisch

Beteiligte Personen:	Janjigian, Yelena Y. [VerfasserIn] Lee, Wooin [VerfasserIn] Kris, Mark G. [VerfasserIn] Miller, Vincent A. [VerfasserIn] Krug, Lee M. [VerfasserIn] Azzoli, Christopher G. [VerfasserIn] Senturk, Emir [VerfasserIn] Wade Calcutt, M. [VerfasserIn] Rizvi, Naiyer A. [VerfasserIn]

Links:	Volltext [lizenzpflichtig]

Themen:	Lung cancer Phase I SJG-136 Solid tumors

RVK:	RVK Klassifikation ELIB24

Anmerkungen:	© Springer-Verlag 2009

doi:	10.1007/s00280-009-1088-4

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	OLC2091740861

Internformat


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520			\|a Purpose SJG-136 is a pyrrolobenzodiazepine dimer that forms DNA crosslinks and has demonstrated broad antitumor activity. We undertook this trial to determine the maximum-tolerated dose (MTD), toxicities and pharmacokinetic (PK) profile of SJG-136 in patients with an advanced solid tumor. Patients and methods In this phase I study, patients were treated with SJG-136 on days 1, 8 and 15 of a 28-day cycle. Dose levels studied were 10, 20, 40 and 60 μg/$ m^{2} $. PK parameters of SJG-136 were assessed following the intravenous administration of SJG-136 on days 1 and 15 of cycle 1. Results Twenty-one patients with advanced solid tumors were treated. Patients had a median of two prior chemotherapy regimens. Fatigue was dose-limiting with SJG-136 60 μg/$ m^{2} $/day administered on days 1, 8 and 15 of a 28-day cycle. Grade 3 thrombocytopenia and delayed onset liver toxicity were seen in one patient each. PK parameters of SJG-136 indicated dose-proportional increases in systemic exposure with increasing doses. No objective responses were seen. Conclusion For patients with advanced solid tumors, the MTD of SJG-136 is 40 μg/$ m^{2} $/day administered on days 1, 8 and 15 of a 28-day cycle. The major dose limiting toxicity was fatigue. Alternative dosing strategies are now being evaluated.
650		4	\|a Phase I
650		4	\|a SJG-136
650		4	\|a Solid tumors
650		4	\|a Lung cancer
700	1		\|a Lee, Wooin \|4 aut
700	1		\|a Kris, Mark G. \|4 aut
700	1		\|a Miller, Vincent A. \|4 aut
700	1		\|a Krug, Lee M. \|4 aut
700	1		\|a Azzoli, Christopher G. \|4 aut
700	1		\|a Senturk, Emir \|4 aut
700	1		\|a Wade Calcutt, M. \|4 aut
700	1		\|a Rizvi, Naiyer A. \|4 aut
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A phase I trial of SJG-136 (NSC#694501) in advanced solid tumors

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