A phase IB trial of intravenous INO-1001 plus oral temozolomide in subjects with unresectable stage-III or IV melanoma

Agop Y. Bedikian, Nicholas E. Papadopoulos, Kevin B. Kim, Wen Jen Hwu, Jade Homsi, Michelle R. Glass, Suzanne Cain, Patrick Rudewicz, Laurent Vernillet, Patrick Hwu

Research output: Contribution to journalArticle

63 Citations (Scopus)

Abstract

INO-1001 is a PARP-1 inhibitor that interrupts the repair process of N-methylpurines generated by temozolomide. We evaluated the pharmacokinetics of INO-1001 and determined its safety when used with temozolomide at 200 mg/m2/day x 5 days every 4 weeks. We enrolled 12 adult patients, in cohorts of 3-6 patients, into the study. INO-1001 at doses of 100, 200 and 400 mg was given intravenous for 1 hr q 12 hr for 10 doses. INO-1001 had a moderate clearance, volume of distribution and a relatively short terminal half-life. Myelosuppression and elevation of liver transaminases were dose-limiting toxicities (DLTs) of INO-1001 at 400 mg.

Original languageEnglish (US)
Pages (from-to)756-763
Number of pages8
JournalCancer Investigation
Volume27
Issue number7
DOIs
StatePublished - Aug 1 2009

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temozolomide
Melanoma
Transaminases
Half-Life
Pharmacokinetics
INO 1001
Safety
Liver

Keywords

  • INO-1001
  • Melanoma
  • PARP inhibitor
  • Pharmacokinetics
  • Temozolomide

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A phase IB trial of intravenous INO-1001 plus oral temozolomide in subjects with unresectable stage-III or IV melanoma. / Bedikian, Agop Y.; Papadopoulos, Nicholas E.; Kim, Kevin B.; Hwu, Wen Jen; Homsi, Jade; Glass, Michelle R.; Cain, Suzanne; Rudewicz, Patrick; Vernillet, Laurent; Hwu, Patrick.

In: Cancer Investigation, Vol. 27, No. 7, 01.08.2009, p. 756-763.

Research output: Contribution to journalArticle

Bedikian, AY, Papadopoulos, NE, Kim, KB, Hwu, WJ, Homsi, J, Glass, MR, Cain, S, Rudewicz, P, Vernillet, L & Hwu, P 2009, 'A phase IB trial of intravenous INO-1001 plus oral temozolomide in subjects with unresectable stage-III or IV melanoma', Cancer Investigation, vol. 27, no. 7, pp. 756-763. https://doi.org/10.1080/07357900802709159
Bedikian, Agop Y. ; Papadopoulos, Nicholas E. ; Kim, Kevin B. ; Hwu, Wen Jen ; Homsi, Jade ; Glass, Michelle R. ; Cain, Suzanne ; Rudewicz, Patrick ; Vernillet, Laurent ; Hwu, Patrick. / A phase IB trial of intravenous INO-1001 plus oral temozolomide in subjects with unresectable stage-III or IV melanoma. In: Cancer Investigation. 2009 ; Vol. 27, No. 7. pp. 756-763.
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