Cancer Chemotherapy and Pharmacology

, Volume 66, Issue 2, pp 395–403 | Cite as

Safety and activity of masitinib in combination with gemcitabine in patients with advanced pancreatic cancer

  • Emmanuel Mitry
  • Pascal Hammel
  • Gaël Deplanque
  • Françoise Mornex
  • Philippe Levy
  • Jean-François Seitz
  • Alain Moussy
  • Jean-Pierre Kinet
  • Olivier Hermine
  • Philippe Rougier
  • Eric Raymond
Clinical Trial Report

Abstract

Purpose

To evaluate the efficacy and safety of masitinib combined with gemcitabine in patients with advanced pancreatic cancer.

Patients and methods

Twenty-two non-randomised patients with unresectable, locally advanced (n = 9) or metastatic pancreatic cancer (n = 13) received oral masitinib (9 mg/kg/day) combined with standard gemcitabine. All patients were naıve to systemic chemotherapy or radiotherapy. The primary endpoint was time-to-progression (TTP) with efficacy and safety analyses performed on the intent-to-treat population. Secondary endpoints included overall survival (OS), as well as, subgroup analyses according to baseline disease, and performance status.

Results

Overall median TTP was 6.4 months (95% CI [2.7–11.7]); 8.3 and 2.7 months, respectively, for locally advanced and metastatic patients; 6.4 and 0.8 months, respectively, for patients with KPS [80–100] or KPS [70]. Median OS was 7.1 months (95% CI [4.8–17.0]); 8.4 and 6.8 months for locally advanced or metastatic patients, respectively; 8.0 and 4.4 months in patients with KPS [80–100] or KPS [70], respectively. The 18-month observed survival rate was similar for locally advanced (22%) and metastatic patients (23%) and reached 28% for KPS [80–100] patients. The most common suspected adverse events were nausea, vomiting, rash, diarrhoea, peripheral oedema, anaemia, lymphopenia, thrombocytopenia, pyrexia, neutropenia, asthenia, leucopoenia, and abdominal pain, and most were of grades 1–2 severity.

Conclusions

The efficacy and safety of masitinib combined with gemcitabine are encouraging, with extended survival and median TTP that support initiation of a phase 3 trial.

Keywords

Advanced pancreatic cancer Masitinib Gemcitabine c-kit FGFR PDGFR 

Notes

Acknowledgments

The authors thank Dr. Marie-Pierre Furrer, PhD and Colin Mansfield, PhD who provided medical writing services on behalf of AB Science. Financial support for this study was provided by AB science, SA.

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Copyright information

© Springer-Verlag 2010

Authors and Affiliations

  • Emmanuel Mitry
    • 1
    • 2
  • Pascal Hammel
    • 3
  • Gaël Deplanque
    • 4
  • Françoise Mornex
    • 5
  • Philippe Levy
    • 3
  • Jean-François Seitz
    • 7
  • Alain Moussy
    • 8
  • Jean-Pierre Kinet
    • 9
  • Olivier Hermine
    • 10
  • Philippe Rougier
    • 1
    • 2
  • Eric Raymond
    • 6
  1. 1.Hépato-gastroentérologie et oncologie digestive, Assistance Publique des Hôpitaux de ParisHôpital Ambroise ParéBoulogne BillancourtFrance
  2. 2.EA4340, Université Versailles Saint QuentinVersailles CedexFrance
  3. 3.Service de gastroentérologie, Fédération médico-chirurgicale d’hépato-gastroentérologieHôpital BeaujonClichyFrance
  4. 4.Service d’OncologieGroupe Hospitalier Paris Saint JosephParisFrance
  5. 5.Service de radiothérapieHôpital Lyon SudPierre BéniteFrance
  6. 6.Service de cancérologieHôpital BeaujonClichy CedexFrance
  7. 7.Service d’hépato-gastroentérologie et oncologie digestiveHôpital de la TimoneMarseilleFrance
  8. 8.AB Science SAParisFrance
  9. 9.Department of PathologyBeth Israel Deaconess Medical center and Harvard Medical SchoolBostonUSA
  10. 10.Service d’Hématologie and CNRS UMR 8147, Hôpital Necker, Assistance Publique des Hôpitaux de ParisUniversité Paris DescartesParisFrance

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