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



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2012
End Date:December 2014

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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

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.


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.
We found this trial at
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New York, New York 10016
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Greenville, South Carolina 29605
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Houston, Texas 77030
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Los Angeles, California 90048
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San Francisco, California 94143
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