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This is a phase 2 study to investigate the efficacy and safety of Pemigatinib in treating patients with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 rearrangement who have failed at least 1 previous therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemigatinib in patients with advanced/metastatic or surgically | Experimental | Patients with advanced/metastatic or surgically unresectable cholangiocarcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemigatinib | Drug | Pemigatinib will be self-administered at 9mg Or 13.5mg as a QD oral treatment on a 2-week-on therapy and 1-week-off therapy schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate per RECIST 1.1 | Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS(PFS= first dose to progressive disease or death) | Time from first treatment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | |
| DOR(DOR= time from the date of CR or PR until PD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36127767 | Derived | Shi GM, Huang XY, Wen TF, Song TQ, Kuang M, Mou HB, Bao LQ, Zhao HT, Zhao H, Feng XL, Zhang BX, Peng T, Zhang YB, Li XC, Yu HS, Cao Y, Liu LX, Zhang T, Wang WL, Ran JH, Liu YB, Gong W, Chen MX, Cao L, Luo Y, Wang Y, Zhou H, Yang GH, Fan J, Zhou J. Pemigatinib in previously treated Chinese patients with locally advanced or metastatic cholangiocarcinoma carrying FGFR2 fusions or rearrangements: A phase II study. Cancer Med. 2023 Feb;12(4):4137-4146. doi: 10.1002/cam4.5273. Epub 2022 Sep 20. |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000705477 | pemigatinib |
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| Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months |
| DCR(DCR=CR + PR + stable disease) | Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months |
| OS(OS= first dose to death of any cause) | Time from first treatment to the date of death from any cause, up to 24 months |
| D009369 | Neoplasms |