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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005290-23 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC-223/erlotinib concurrent | Experimental | Cohorts will receive escalating continuous daily doses (15 mg and 30 mg) of CC-223 in capsules concurrently with at least two different daily dose levels of erlotinib tablets (100 mg and 150 mg) in 28-day cycles. |
|
| CC-223/oral azacitidine concurrent | Experimental | Cohorts will receive escalating continuous daily doses of CC-223 (15 mg and 30 mg) with one or more dose levels of oral azacitidine (200 mg or 300 mg, as two or three 100 mg tablets) administered on Day 1 to 21 of each 28-day cycle. |
|
| CC-223/oral azacitidine sequential | Experimental | Cohorts will receive escalating continuous daily dose levels of CC-223 (15 mg and 30 mg) administered on Days 8 through 28 sequentially with one or more dose levels of of oral azacitidine (200 mg or 300 mg, as two or three 100 mg tablets) administered on Days 1 to 7 of each 28-day cycle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-223, erlotinib | Drug | Dose escalation: Combination doses start with 15 mg CC-223 and 100 mg erlotinib, or 15 mg CC-223 and 150 mg erlotonib, administered in 28-day cycles. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study. Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of participants with adverse events | Up to 24 months |
| MTD | Maximum tolerated dose (MTD) | Up to 24 months |
| PK-Cmax | Pk-Maximum observed concentration in plasma (Cmax) | Up to 15 months |
| PK-AUC | Area under the plasma concentration-time curve (AUC) | Up to 15 months |
| PK-Tmax | PK-Time to maximum concentration (Tmax) | Up to 15 months |
| PK-T1/2 | PK-Terminal half-life (T1/2) | Up to 15 months |
| PK-CL/F | PK-Apparent total body clearance (CL/F) | Up to 15 months |
| PK-Vz/F | PK-Apparent volume of distribution (Vz/F) | Up to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| mTORC1 and mTORC2 pathway biomarkers | The effect of treatment on mTORC1 and mTORC2 pathway biomarkers in blood and tumor | Up to 15 months. |
| CC-223 metabolite, M1 | CC-223 metabolite, M1, will be characterized |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Hege, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center, Inflammatory Bowel Disease Center | Los Angeles | California | 90048 | United States | ||
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|
| CC-223, oral azacitidine | Drug | Dose escalation: Combination doses start with 15 mg CC-223 and 200 mg oral azacitidine, administered in 28-day cycle. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study. Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy |
|
| CC-223, oral azacitidine | Drug | Dose escalation: Sequential dosing starts with 200 mg of oral azacitidine administered on Days 1 through 7 of each 28-day cycle, followed by daily dose level of 15 mg CC-223 on Days 8 through 28. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study. Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy |
|
| Up to 9 months |
| Tumor Response Rate | Tumor Response Rate using RECIST 1.1 (Eisenhauer, 2009) | Up to 24 months |
| Number of participants surviving without tumor progression | Number of participants surviving without tumor progression | Up to 24 months |
| University of California, San Francisco |
| San Francisco |
| California |
| 9411 |
| United States |
| NYU School of Medicine | New York | New York | 10016 | United States |
| Cancer Center of the Carolinas | Greenville | South Carolina | 29605 | United States |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232-5505 | United States |
| Mary Crowley Cancer Research Centers - Medical City | Dallas | Texas | 75201 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Vall d´Hebron University Hospital | Barcelona | 08035 | Spain |
| Hospital Virgen del Rocio Servicio de Hematologia | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000601736 | CC-223 |
| D000069347 | Erlotinib Hydrochloride |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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