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

Completed · Phase 1

Conditions studied: Glioblastoma Multiforme, Squamous Cell Carcinoma of Head and Neck, Prostate Cancer, Ewing's Osteosarcoma, Chronic Lymphocytic Leukemia, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT01353625

Run by

Celgene

People needed

118

Starts

2011-04-25

Expected to finish

2021-03-12

Last updated by the study team

2021-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• University of California, San Francisco Comprehensive Cancer Center and Cancer Research Institiute — San Francisco, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Henry Ford Medical Center - New Center One — Detroit, Michigan, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Sarah Cannon Research Institute Drug Development Unit — Nashville, Tennessee, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Gustave Roussy — Villejuif, France
• Uniklinik Koln — Cologne, Germany
• Universitatsklinikum Wurzburg — Würzburg, Germany
• Hospital Val d'Hebron — Barcelona, Spain
• Hospital Universitario Madrid Sanchinarro — Madrid, Spain
• Hospital de Donosti — San Sebastián (Guipuzcoa), Spain
• Hospital Virgen del Rocio — Seville, Spain

Full record on ClinicalTrials.gov

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