Breast Cancer Clinical Trial
Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma
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.
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.
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
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 â‰¥ Grade 2, impaired GI absorption
Impaired cardiac function
Diabetes requiring Rx, glucose >126 mg/dL, HbA1c â‰¥6.5%
Peripheral neuropathy â‰¥ Grade 2
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
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There are 16 Locations for this study
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
San Francisco California, 94115, United States
Tampa Florida, 33612, United States
Rochester Minnesota, 55905, United States
Billings Montana, 59102, United States
Hackensack New Jersey, 07601, United States
New York New York, 10016, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75201, United States
Toulouse Cedex , 31052, France
Villejuif , 94800, France
Salamanca , 37007, Spain
Sevilla , 41013, Spain
London , W1G 6, United Kingdom
London , WC1E , United Kingdom
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