CompletedPhase 1NCT01545947

Study Assessing Safety, Pharmacokinetics and Efficacy of CC-223 With Either 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.

Checked against the public recordLast updated Nov 12, 2019 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations9
SponsorCelgene
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Celgene
Interventions being studied
Drug: CC-223, erlotinib; Drug: CC-223, oral azacitidine; Drug: CC-223, oral azacitidine
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Cedars Sinai Medical Center, Inflammatory Bowel Disease CenterLos Angeles, California
  • University of California, San FranciscoSan Francisco, California
  • NYU School of MedicineNew York, New York
  • Cancer Center of the CarolinasGreenville, South Carolina
  • Henry-Joyce Cancer ClinicNashville, Tennessee
  • Mary Crowley Cancer Research Centers - Medical CityDallas, Texas
  • The University of Texas MD Anderson Cancer CenterHouston, Texas
  • Vall d´Hebron University HospitalBarcelona
  • Hospital Virgen del Rocio Servicio de HematologiaSeville

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 12, 2019. Always confirm current availability with the study team.

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