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This is a phase 1 study to investigate the characteristics of PK, PD and safety in subjects with advanced malignancies with FGF/FGFR alterations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with advanced malignancies with FGF/FGFR alterations | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemigatinib | Drug | Pemigatinib will be self-administered as at 13.5mg a QD oral treatment on a 2-week-on therapy and 1-week-off therapy schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy | Day 1 to Day 16 | |
| Time to maximum plasma concentration (Tmax) of Pemigatinib as monotherapy | Day 1 to Day 16 | |
| Area under the single-dose plasma concentration-time curve (AUC0-t) of Pemigatinib as monotherapy | Day 1 to Day 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of pemigatinib as monotherapy as assessed by the frequency, duration, and severity of adverse events | From screening through 30-35 days after end of treatment, up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Tianjin Medical University | Tianjin | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37889382 | Derived | Deng T, Zhang L, Shi Y, Bai G, Pan Y, Shen A, Han X, Yang Z, Chen M, Zhou H, Luo Y, Zheng S, Ba Y. Pharmacokinetics, pharmacodynamics and efficacy of pemigatinib (a selective inhibitor of fibroblast growth factor receptor 1-3) monotherapy in Chinese patients with advanced solid tumors: a phase i clinical trial. Invest New Drugs. 2023 Dec;41(6):808-815. doi: 10.1007/s10637-023-01396-x. Epub 2023 Oct 27. |
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| ID | Term |
|---|---|
| C000705477 | pemigatinib |
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