Know Cancer

forgot password

A Phase 1b, Multi-Center, Open-Label Study of the mTOR Kinase Inhibitor CC-223 in Combination With Erlotinib or Oral Azacitidine in Advanced Non-Small Cell Lung Cancer

Phase 1
18 Years
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung, Non-Small Cell Lung Cancer

Thank you

Trial Information

A Phase 1b, Multi-Center, Open-Label Study of the mTOR Kinase Inhibitor CC-223 in Combination With Erlotinib or Oral Azacitidine in Advanced Non-Small Cell Lung Cancer

Inclusion Criteria:

1. 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.

2. Eastern Cooperative Oncology Group Performance Score of 0 to 1.

3. Adequate organ function.

4. Adequate contraception (if appropriate).

5. Consent to retrieve archival tumor tissue.

6. Consent to repeated tumor biopsy (dose expansion phase).

Exclusion Criteria:

1. 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.

2. Symptomatic central nervous system metastases.

3. Acute or chronic pancreatitis.

4. Persistent diarrhea or malabsorption > Grade 2, despite medical management.

5. Impaired cardiac function or significant cardiac disease.

6. Diabetes on active treatment, fasting blood glucose > 126 mg/dL, HbA1c > 6.5%.

7. Known Human Immunodeficiency Virus, chronic hepatitis B or C infection.

8. Prior treatment with an investigational dual TORC1/TORC2, PI3K, or Akt inhibitor.
Prior treatment with rapalogs is allowed.

9. 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.

10. Pregnant or breastfeeding, inadequate contraception.

11. History of concurrent second malignancies requiring ongoing systemic treatment.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events

Outcome Description:

Number of participants with adverse events

Outcome Time Frame:

Up to 24 months

Safety Issue:


Principal Investigator

Kristen Hege, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

March 2014

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Non-Small Cell Lung Cancer
  • Neoplasms
  • Pulmonary
  • Lung Cancer
  • Cancer of the Lung
  • Stage IIIB Non-Small Cell Lung Cancer
  • IV Non-Small Cell Lung Cancer
  • Non-Small Cell Lung Cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
NYU Cancer Institute New York, New York  10016
University of California San Francisco San Francisco, California  941104206
University of Texas MD Anderson Houston, Texas  77030
Mary Crowley Cancer Research Center Dallas, Texas  75246
Cedars Sinai Los Angeles, California  90048
ITOR Cancer Center of North Carolina Greenville, South Carolina  29605