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Kadmon has made a business decision to terminate the study due to slow enrollment. Note the decision to terminate the study was not related to safety issues
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This study involves treatment with KD019 or erlotinib in patients with Non-small cell lung cancer (NSCLC) who have progressed after first- or second- line chemotherapy. It is hypothesized that KD019 can prolong survival compared with erlotinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KD019 | Experimental | KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted. |
|
| Erlotinib | Active Comparator | Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KD019 | Drug | KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year | |
| Number and type of adverse events related to KD019 | For the purpose of data collection, all untoward events that occur after informed consent through 30 days after last dose of study treatment are to be recorded. |
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For Eligibility subjects must have:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06519 | United States | ||
| San Juan Oncology Associates |
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| Erlotinib | Drug | Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted. |
|
|
| Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year |
| Objective response rate | Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year |
| Farmington |
| New Mexico |
| 87401 |
| United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C571826 | XL647 |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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