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

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 standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trials.

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Full 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 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.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

226

Study ID:

NCT01177397

Recruitment Status:

Completed

Sponsor:

Celgene

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There are 16 Locations for this study

See Locations Near You

Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
UCLA Neuro-Oncology Program
Los Angeles California, 90095, United States
University of California, San Francisco Hellen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Mayo Clinic Cancer Clinical Studies Unit
Rochester Minnesota, 55905, United States
Billings Clinic
Billings Montana, 59102, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
NYU Cancer Institute - Bellevue Hospital
New York New York, 10016, United States
Sarah Cannon Research Institute Drug Development Unit
Nashville Tennessee, 37203, United States
Mary Crowley Medical Research Center
Dallas Texas, 75201, United States
Institut Claudius Regaud
Toulouse Cedex , 31052, France
Institut Gustave Roussy Faculte de Medecine Paris Sud Service de pneumologie
Villejuif , 94800, France
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain
Sarah Cannon Research Institute UK
London , W1G 6, United Kingdom
UCL Cancer Institute
London , WC1E , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

226

Study ID:

NCT01177397

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

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