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This study aims to evaluate the safety and tolerability of JPI-547 in combination with irinotecan as a third-line and beyond therapy for recurrent or metastatic gastric cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JPI-547 and Irinotecan | Experimental | coadministration of JPI-547 and Irinotecan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JPI-547 | Drug | The dose levels will be escalated following a 3+3 dose escalation scheme. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1b: dose-limiting toxicity rate | The dose-limiting toxicity evaluation window is 28 days from C1D1. | |
| phase 2: Overall Response Rate (ORR) according to RECIST v1.1 | At 6-week intervals through study completion, an average of 3 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Onconic Therapeutics Inc. | Contact | 82-2-3454-0780 | onconictherapeutics@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei Cancer Center, Yonsei University College of Medicine | Seoul | South Korea |
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| Irinotecan (drug) | Drug | The dose levels will be escalated following a 3+3 dose escalation scheme. |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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