Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma

Completed · Phase 1/Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01177397

Run by

Celgene

People needed

226

Starts

2010-07-20

Expected to finish

2016-12-09

Last updated by the study team

2022-12-13

Who can join

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

You may qualify if…

• Histologically-confirmed advanced solid tumor, Non-Hodgkin Lymphoma or multiple myeloma
• Patients have not tolerated or progressed on standard therapy, and no further standard therapy is available
• Archival and screening tumor biopsy
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (solid tumors), 0-2 (hematologic malignancy)
• Adequate organ function

You may not qualify if…

• Prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5 half lives, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy. Subjects must have recovered from any effects of recent radiotherapy that might confound the safety evaluation of study drug
• Symptomatic brain metastases (prior Rx and stable metastases are OK)
• Acute or chronic liver or renal disease or pancreatitis
• Diarrhea ≥ Grade 2, impaired GI absorption
• Impaired cardiac function
• Diabetes requiring Rx, glucose >126 mg/dL, HbA1c ≥6.5%
• Peripheral neuropathy ≥ Grade 2
• Pulmonary fibrosis
• Known HIV infection
• Known chronic hepatitis B or C virus (HBV/HCV) infection, unless comorbidity in subjects with HCC
• Pregnant, inadequate contraception
• Most concurrent second malignancies

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UCLA Neuro-Oncology Program — Los Angeles, California, United States
• University of California, San Francisco Hellen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Mayo Clinic Cancer Clinical Studies Unit — Rochester, Minnesota, United States
• Billings Clinic — Billings, Montana, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• NYU Cancer Institute - Bellevue Hospital — 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
• Institut Claudius Regaud — Toulouse, France
• Institut Gustave Roussy Faculte de Medecine Paris Sud Service de pneumologie — Villejuif, France
• Hospital Universitario de Salamanca — Salamanca, Spain
• Hospital Universitario Virgen Del Rocio — Seville, Spain
• Sarah Cannon Research Institute UK — London, United Kingdom
• UCL Cancer Institute — London, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.