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Clinical Trial VICCTHN1242

Title

A Phase IB, 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

Principal Investigator(s)

Leora Horn

Details

  • Protocol No. VICCTHN1242
  • Open Date: 10/24/2012
  • Staging: Phase I
  • Age Group: Adults
  • Scope: National
  • Objective: The primary objectives of the study are to: - Determine the safety and tolerability of CC-223 when administered orally in combination with either erlotinib or oral azacitidine and to define the non-tolerated dose (NTD) and the maximum tolerated dose (MTD) of each combination. - Characterize the pharmacokinetics (PK) of CC-223 and azacitidine following oral administration as single agents and after combination treatment.
  • Disease Sites: Lung; Non Small Cell
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Azacitidine; CC-223; Tarceva (OSI-774; erlotinib)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01545947
  • Secondary Protocol No: CC-223-NSCL-001

Description

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.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

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.