A Phase 1 / 2 Study of HKI-272 in combination With Paclitaxel in Subjects With Solid Tumors and Breast Cancer

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-006412-29

Femme et Homme

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Extrait

Part 1: The primary objectives of part 1 are to assess the safety and tolerability, and to define the MTD of HKI-272 in combination with paclitaxel in subjects with advanced solid tumors Part 2: The primary objective of part 2 of this study is to estimate the overall response rate (ORR) for subjects with HER2 positive breast cancer treated at the MTD of HKI-272 in combination with paclitaxel.


Critère d'inclusion

  • Metastatic breast cancer remains incurable and represents an area of unmet medical need globally. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) activation occurs in breast cancer. This activation contributes to the development and metastatic potential of breast cancer. Dual EGFR/HER2 inhibitors may have activity in the treatment of prior trastuzumab treated HER2 positive metastatic breast cancer

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