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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Seoul National Hospital | OTHER_GOV |
| Gangnam Severance Hospital |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | Lurbinectedin shall be administered intravenously at a dose of 3.2 mg/m2 over 60 minutes every 21 days. The administration of the study drug shall be continued until disease progression or the occurrence of unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurbinectedin 4 MG Injection [Zepzelca] | Drug | Lurbinectedin shall be administered intravenously at a dose of 3.2 mg/m2 over 60 minutes every 21 days. The administration of the study drug shall be continued until disease progression or the occurrence of unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| The overall response rate | The proportion of participants who achieve a complete response (CR) or partial response (PR) as determined by the investigators according to the Response Evaluation Criteria in Solid Tumors | From date of first administration of drug until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24months" |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate | 1. Disease control is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) as assessed by investigators per RECIST v1.1 criteria. | From date of the first administration of drug until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue and blood sampling for discovering biomarkers | Biomarker should be identified by statistical methods for correlation between disease control rates, response duration, progression-free survival, and overall survival. | Every 6 weeks (two 28-day cycles) until the end of Cycle 6, and then every 9 weeks (three 28-day cycles) until documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Myung Woo(Principal), MD | National Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32864039 | Background | Zhang MY, He D, Zhang S. Pancreatic neuroendocrine tumors G3 and pancreatic neuroendocrine carcinomas: Differences in basic biology and treatment. World J Gastrointest Oncol. 2020 Jul 15;12(7):705-718. doi: 10.4251/wjgo.v12.i7.705. | |
| 32224306 | Background | Trigo J, Subbiah V, Besse B, Moreno V, Lopez R, Sala MA, Peters S, Ponce S, Fernandez C, Alfaro V, Gomez J, Kahatt C, Zeaiter A, Zaman K, Boni V, Arrondeau J, Martinez M, Delord JP, Awada A, Kristeleit R, Olmedo ME, Wannesson L, Valdivia J, Rubio MJ, Anton A, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D'Arcangelo M, Santoro A, Villalobos VM, Sands J, Paz-Ares L. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020 May;21(5):645-654. doi: 10.1016/S1470-2045(20)30068-1. Epub 2020 Mar 27. |
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Plans for sharing individual participant data have not yet been finalized.
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| ID | Term |
|---|---|
| D007516 | Adenoma, Islet Cell |
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C568606 | PM 01183 |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| OTHER |
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| Duration of response | from date of first response to the date of disease progression, relapse, or death | From date of first documented response until the date of disease progression, relapse, or death from any cause, whichever occurs first, assessed up to 24 months. |
| Progression-free survival | time from the date of first infusion to disease progression or death from any cause | From the date of first infusion until the date of first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months. |
| Overall survival | from the date of first infusion to death or loss to follow-up | from the date of first infusion until death from any cause or loss to follow-up, whichever occurs first, assessed up to 24 months. |
| Evaluate the safety and tolerability of Lurbinectedin | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | From the date of first infusion until disease progression or death from any cause, whichever occurs first, assessed up to 24 months. |
| 35830841 | Background | Longo-Munoz F, Castellano D, Alexandre J, Chawla SP, Fernandez C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Moreno V, Sanz-Garcia E, Awada A, Santaballa A, Subbiah V. Lurbinectedin in patients with pretreated neuroendocrine tumours: Results from a phase II basket study. Eur J Cancer. 2022 Sep;172:340-348. doi: 10.1016/j.ejca.2022.06.024. Epub 2022 Jul 10. |
| D010190 |
| Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |