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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01177397
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Celgene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries France, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being 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
Additional Details

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.

Arms & Interventions

Arms

Experimental: CC-223

All patients will receive CC-223, but serial patient groups will receive different dose levels in Phase 1. The number of groups will be determined by the number of dose levels required to establish dose-limiting toxicity.

Interventions

Drug: - CC-223

Part A: (closed to enrollment) Dose level starts with 7.5mg daily taken by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose level is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: (closed to enrollment) Optimal dose is administered in 28 day cycles until disease progression.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cedars-Sinai Medical Center, Los Angeles, California

Status

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

UCLA Neuro-Oncology Program, Los Angeles, California

Status

Address

UCLA Neuro-Oncology Program

Los Angeles, California, 90095

San Francisco, California

Status

Address

University of California, San Francisco Hellen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115

Moffitt Cancer Center, Tampa, Florida

Status

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Mayo Clinic Cancer Clinical Studies Unit, Rochester, Minnesota

Status

Address

Mayo Clinic Cancer Clinical Studies Unit

Rochester, Minnesota, 55905

Billings Clinic, Billings, Montana

Status

Address

Billings Clinic

Billings, Montana, 59102

Hackensack University Medical Center, Hackensack, New Jersey

Status

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

NYU Cancer Institute - Bellevue Hospital, New York, New York

Status

Address

NYU Cancer Institute - Bellevue Hospital

New York, New York, 10016

Nashville, Tennessee

Status

Address

Sarah Cannon Research Institute Drug Development Unit

Nashville, Tennessee, 37203

Mary Crowley Medical Research Center, Dallas, Texas

Status

Address

Mary Crowley Medical Research Center

Dallas, Texas, 75201

International Sites

Institut Claudius Regaud, Toulouse Cedex, France

Status

Address

Institut Claudius Regaud

Toulouse Cedex, , 31052

Villejuif, France

Status

Address

Institut Gustave Roussy Faculte de Medecine Paris Sud Service de pneumologie

Villejuif, , 94800

Hospital Universitario de Salamanca, Salamanca, Spain

Status

Address

Hospital Universitario de Salamanca

Salamanca, , 37007

Hospital Universitario Virgen Del Rocio, Sevilla, Spain

Status

Address

Hospital Universitario Virgen Del Rocio

Sevilla, , 41013

Sarah Cannon Research Institute UK, London, United Kingdom

Status

Address

Sarah Cannon Research Institute UK

London, , W1G 6AD

UCL Cancer Institute, London, United Kingdom

Status

Address

UCL Cancer Institute

London, , WC1E 6BT

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