Conditions: Multiple Myeloma Diffuse Large B-Cell Lymphoma Glioblastoma Multiforme Hepatocellular Carcinoma Non-Small Cell Lung Cancer Neuroendocrine Tumors of Non-Pancreatic Origin Hormone Receptor-Positive Breast Cancer
Keywords: Advanced solid malignant neoplasms,Non-Hodgkin Lymphoma, Multiple Myeloma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 226
Healthy volunteers: no

Brief summary:
The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trials.

Detailed description:
Initially, patients will be treated with oral CC-223 for one month. During this time, various tests (involving blood and urine collections, ECGs, etc) will be performed. Those whose tumors stabilize or regress may continue receiving treatment for as long as they benefit from CC-223. Different dose levels of CC-223 will be tested in a dose-rising study design.

Arms:
arm 1: All patients will receive CC-223, but serial patient groups will receive different dose levels in Phase 1. The number of groups will be determined by the number of dose levels required to establish dose-limiting toxicity.

Interventions: intervention 1: CC-223
Intervention descriptions: intervention 1: Part A: (closed to enrollment) Dose level starts with 7.5mg daily taken by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose level is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: (closed to enrollment) Optimal dose is administered in 28 day cycles until disease progression.

Protocol document: