Status:
COMPLETED
Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma
Lead Sponsor:
Celgene
Conditions:
Multiple Myeloma
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 st...
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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 20 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2016
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT01177397
Start Date
July 20 2010
End Date
December 9 2016
Last Update
December 13 2022
Active Locations (16)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
UCLA Neuro-Oncology Program
Los Angeles, California, United States, 90095
3
University of California, San Francisco Hellen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612