Skip to main content
main-content

30.04.2016 | Original Article | Ausgabe 6/2016

Cancer Chemotherapy and Pharmacology 6/2016

A phase I study evaluating cixutumumab, a type 1 insulin-like growth factor receptor inhibitor, given every 2 or 3 weeks in Japanese patients with advanced solid tumors

Zeitschrift:
Cancer Chemotherapy and Pharmacology > Ausgabe 6/2016
Autoren:
Toshihiko Doi, Kohei Shitara, Takashi Kojima, Takayuki Yoshino, Aruna Dontabhaktuni, Hans Rebscher, Shande Tang, Jan Cosaert, Atsushi Ohtsu

Abstract

Purpose

The primary objective of this phase I trial was to establish the safety profile and pharmacokinetics of cixutumumab administered every 2 weeks (q2w) or every 3 weeks (q3w) in Japanese patients with advanced solid tumors. Exploratory analyses included preliminary antitumor activity.

Methods

Patients received intravenous cixutumumab q2w or q3w (6-week cycle) in a standard 3 + 3 study design. Safety was evaluated by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. Patients received treatment until evidence of progressive disease or other withdrawal criteria were met. Pharmacokinetics were described using noncompartmental analyses. Antitumor activity was evaluated using Response Evaluation Criteria in Solid Tumors v1.0.

Results

A total of 21 patients were treated in one of four cohorts: 6 mg/kg q2w (n = 4); 10 mg/kg q2w (n = 7); 15 mg/kg q3w (n = 3); or 20 mg/kg q3w (n = 7). No patients experienced dose-limiting toxicity. A majority of patients (61.9 %) experienced one or more drug-related adverse event (AE). Related AEs included impaired glucose tolerance (n = 6 [28.6 %]) and diarrhea, nausea, stomatitis, fatigue, weight decrease, anorexia, rash, and hypertension (n = 2 each [9.5 %]). A best overall response of stable disease was seen in seven patients (33.3 %). The median duration of stable disease was 6.9 months (range 2.8, 6.9) for all cohorts. Although limited, pharmacokinetic results were as expected and were comparable between Japanese and Caucasian patients.

Conclusion

Cixutumumab was generally well tolerated with no new safety concerns.

Clinical Trials.gov identifier

NCT01007032.

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

★ PREMIUM-INHALT
e.Med Interdisziplinär

Mit e.Med Interdisziplinär erhalten Sie Zugang zu allen CME-Fortbildungen und Fachzeitschriften auf SpringerMedizin.de. Zusätzlich können Sie eine Zeitschrift Ihrer Wahl in gedruckter Form beziehen – ohne Aufpreis.

Jetzt e.Med zum Sonderpreis bestellen!

Weitere Produktempfehlungen anzeigen
Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 6/2016

Cancer Chemotherapy and Pharmacology 6/2016 Zur Ausgabe
  1. Sie können e.Med Innere Medizin 14 Tage kostenlos testen (keine Print-Zeitschrift enthalten). Der Test läuft automatisch und formlos aus. Es kann nur einmal getestet werden.

  2. Das kostenlose Testabonnement läuft nach 14 Tagen automatisch und formlos aus. Dieses Abonnement kann nur einmal getestet werden.


 

Neu im Fachgebiet Onkologie

Mail Icon II Newsletter

Bestellen Sie unseren kostenlosen Newsletter Update Onkologie und bleiben Sie gut informiert – ganz bequem per eMail.

Bildnachweise