Full TitleAn Open-label Phase 1b Study of ARQ 092 in Combination with Other Antineoplastic Agents in Subjects with Selected Solid Tumors
This study is assessing the safety and optimal dose of the investigational drug ARQ 092 in combination with other anticancer drugs in patients with solid tumors that have continued to grow or came back despite standard therapies or for which no effective standard therapies exist. ARQ 092 works by inhibiting a protein involved in cancer growth called AKT.
In this study, patients will receive ARQ 092 in combination with paclitaxel, carboplatin and paclitaxel, or anastrozole (ovarian and endometrial cancers only). ARQ 092 and anastrazole are given orally (by mouth); carboplatin and paclitaxel are given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have an advanced, inoperable, or metastatic solid tumor that cannot be successfully treated with other therapies.
- Patients in the anastrozole group must have ovarian or endometrial cancer has mutations in the AKT1 or PIK3CA genes and expresses the estrogen receptor.
- At least 4 weeks must pass between the completion of prior therapies and entry into the study (2 weeks since oral anticancer therapies).
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.