Phase III

Afatinib

Description: Afatinib is a tyrosine kinase inhibitor that blocks irreversibly EGFR and HER2. Two Phase III studies are enrolling patients. First is evaluating efficacy and safety of Afatinib as adjuvant treatment. Patients with primary unresected loco-regionally advanced (stages III, IVA, IVB) Head and Neck Cancer will be randomized to receive Afatinib or placebo after chemo-radiotherapy. Second Phase III study is evaluating the efficacy and safety of oral Afatinib versus intravenous Methotrexate in patients with recurrent and/ or metastatic Head and neck Cancer who have progressed after platinum-based therapy.
Type(s) of Cancer: Head and Neck
Study Phase(s): Phase III
Contact: Epp Goodwin at (210) 450-5798

E1305

Description:

In this Phase III study patients with recurrent or metastatic Head and Neck Cancer will be randomized to receive standard platinum-based chemotherapy with or without Bevacizumab. Standard regimen can be Docetaxel+Cisplatin(Carbo) or Cisplatin (Carbo)+ 5-FU.


Type(s) of Cancer: Head and Neck
Study Phase(s): Phase III
Contact: Epp Goodwin at (210) 450-5798

S0337

Description:

Title: Phase III blinded study of immediate post-TURBT instillation of Gemcitabine versus Saline in patients with newly diagnosed or occasionally recurring grade I/II superficial bladder cancer.


Type(s) of Cancer: Bladder Related
Study Phase(s): Phase III
Contact: Epp Goodwin at (210) 450-5798

S0931

Description:

This Phase III study compares the recurrence-free survival as well as overall survival of patients with renal cell carcinoma receiving everolimus or placebo after full surgical resection and who have no residual or metastatic disease.


Type(s) of Cancer: Kidney
Study Phase(s): Phase III
Contact: Epp Goodwin at (210) 450-5798