Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.

• Status: Completed
• Trial end date: 2021-03-12
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation

Criteria

Inclusion Criteria:

• Histologically-confirmed advanced solid tumor, chronic lymphocytic leukemia, small lymphocytic lymphoma, T-cell prolymphocytic leukemia, Non-Hodgkin Lymphoma or multiple myeloma

• Progressed or not tolerated standard therapy, and no further standard therapy is available

• Archival and screening tumor biopsy

• Eastern Cooperative Oncology Group Performance Status: 0 or 1

• Adequate organ function

Exclusion Criteria:

• Prior cancer-directed modalities or investigational drugs within 4 wks or 5 half lives, whichever is shorter

• Symptomatic brain metastases (prior treatment and stable metastases are allowed)

• Acute or chronic renal disease or pancreatitis

• Diarrhea ≥ Grade 2, impaired gastrointestinal absorption

• Impaired cardiac function

• History of diabetes requiring treatment, glucose >126 mg/dL, Glycated hemoglobin (HbA1c) ≥6.5%

• Peripheral neuropathy ≥ Grade 2

• Known Human Immunodeficiency Virus (HIV) infection, chronic hepatitis B or C (unless associated with hepatocellular cancer)

• Pregnant, inadequate contraception, breast feeding

• Most concurrent second malignancies

• Part B only: Prior treatment with agents targeting both mammalian target of rapamycin (mTOR) complexes (dual mammalian target of rapamycin complex 1/2 inhibitors) and/or PI3K/AKT pathways. However, prior treatment with isolated target of rapamycin complex 1 (TORC1) inhibitors (eg., rapalogs) is allowed in both parts of this study.