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COMPLETEDPHASE1

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

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

NCT01545947•Celgene

View on ClinicalTrials.gov

Summary

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (9)

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

Key Dates

Start Date

May 1, 2012

Primary Completion Date

December 11, 2014

Completion Date

December 11, 2014

Last Updated

November 12, 2019

Enrollment

ACTUAL participants

Conditions

Carcinoma, Non-Small-Cell LungNon-Small Cell Lung Cancer

Interventions

CC-223, erlotinib

DRUG

CC-223, oral azacitidine

DRUG

CC-223, oral azacitidine

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

View study

RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 12, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations