J1330 : MM-111-13-02-04: Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel with or without Trastuzumab in Patients with â??Traditionalâ?? and â??Non-Traditionalâ?? HER2 Expressing Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
To determine the benefits of using MM-111 in combination with Paclitaxel and/or Trastuzumab or with Paclitaxel alone in 2 groups of HER2 expressing patients with metastatic or locally advanced (unresectable) HER2 distal esophagus, GE Junction or gastric cancer.
Metastatic or locally advanced cancer of the distal esophagus, GE junction or stomach-confirmed HER2 expression-received one prior systemic standard fluoropyrimidine/platinum-based therapy with or witout trastuzumab for metastatic disease-good physical condition with good blood counts and organ function-patients who have received paclitaxel or taxane treatment are not eligible
Phase II: This is a multicenter randomized clinical trial that is not blinded. We expected up to 6 participants at Hopkins. Patients will randomized to one of 4 arms:Paclitaxel, Trastuzumab plus MM-111; Paclitaxel plus Trastuzumab; Paclitaxel plus MM-111;or Paclitaxel alone. For specific study drug treatment information, please contact Rosalind Walker, RN, at firstname.lastname@example.org.
04/16/2014 04:02 AM