Study Assessing Safety, Pharmacokinetics and Efficacy of CC-223 With Either Erlotinib or Oral Azacitidine in Advanced Non-Small Cell Lung Cancer

Completed · Phase 1

Conditions studied: Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer

In brief

The main purpose of this first study combining an investigational dual mTOR inhibitor, CC-223, with other agents (erlotinib or the investigational agent, oral azacitidine) is to establish a maximum tolerated dose level for each combination in order to evaluate their effects in future clinical trials for advanced non-small cell lung cancer.

Key facts

Study ID

NCT01545947

Run by

Celgene

People needed

76

Starts

2012-05-01

Expected to finish

2014-12-11

Last updated by the study team

2019-11-12

Who can join

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

You may qualify if…

• Men and women, 18 years or older, with histologically or cytologically-confirmed, Stage IIIB/IV Non-Small Cell Lung Cancer with tumor progression following at least one prior treatment regimen (either chemotherapy or an Epidermal Growth Factor Receptor inhibitor) for advanced disease. There is no restriction on the number of prior treatment regimens allowed.
• Eastern Cooperative Oncology Group Performance Score of 0 to 1.
• Adequate organ function.
• Adequate contraception (if appropriate).
• Consent to retrieve archival tumor tissue.
• Consent to repeated tumor biopsy (dose expansion phase).

You may not qualify if…

• Prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5 half lives, whichever is shorter except erlotinib which may be continued with intervention in subjects allocated in Arm A.
• Symptomatic central nervous system metastases.
• Acute or chronic pancreatitis.
• Persistent diarrhea or malabsorption > Grade 2, despite medical management.
• Impaired cardiac function or significant cardiac disease.
• Diabetes on active treatment, fasting blood glucose > 126 mg/dL, HbA1c > 6.5%.
• Known Human Immunodeficiency Virus, chronic hepatitis B or C infection.
• Prior treatment with an investigational dual TORC1/TORC2, PI3K, or Akt inhibitor. Prior treatment with rapalogs is allowed.
• Major surgery < 2 weeks prior to starting study drugs. No specific wash out is required for radiotherapy. Subjects must have recovered from any effects of recent therapy that might confound the safety evaluation of study drug.
• Pregnant or breastfeeding, inadequate contraception.
• History of concurrent second malignancies requiring ongoing systemic treatment.

Where it is running

• Cedars Sinai Medical Center, Inflammatory Bowel Disease Center — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• NYU School of Medicine — New York, New York, United States
• Cancer Center of the Carolinas — Greenville, South Carolina, United States
• Henry-Joyce Cancer Clinic — Nashville, Tennessee, United States
• Mary Crowley Cancer Research Centers - Medical City — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Vall d´Hebron University Hospital — Barcelona, Spain
• Hospital Virgen del Rocio Servicio de Hematologia — Seville, Spain

Full record on ClinicalTrials.gov

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