Publications
Detailed Information
TAK-264 (MLN0264) in previously treated Asian patients with advanced gastrointestinal carcinoma expressing guanylyl cyclase C: Results from an open-label, non-randomized phase 1 study
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Takano, Toshimi | - |
dc.contributor.author | Lin, Chia-Chi | - |
dc.contributor.author | Fasanmade, Adedigbo | - |
dc.contributor.author | Yang, Huyuan | - |
dc.contributor.author | Danaee, Hadi | - |
dc.contributor.author | Asato, Takayuki | - |
dc.contributor.author | Kalebic, Thea | - |
dc.contributor.author | Wang, Hui | - |
dc.contributor.author | Doi, Toshihiko | - |
dc.date.accessioned | 2021-01-31T11:58:28Z | - |
dc.date.available | 2021-01-31T11:58:28Z | - |
dc.date.created | 2019-07-30 | - |
dc.date.issued | 2018-04 | - |
dc.identifier.citation | Cancer Research and Treatment, Vol.50 No.2, pp.398-404 | - |
dc.identifier.issn | 1598-2998 | - |
dc.identifier.other | 80112 | - |
dc.identifier.uri | https://hdl.handle.net/10371/173174 | - |
dc.description.abstract | Purpose This phase 1 dose-escalation portion of the study evaluated the safety, pharmacokinetics (PK), and antitumor activity of TAK-264 in Asian patients with advanced gastrointestinal (GI) carcinoma or metastatic or recurrent gastric or gastroesophageal junction adenocarcinoma expressing guanylyl cyclase C (GCC). Materials and Methods Adult patients with advanced GI malignancies expressing GCC (H-score >= 10) received TAK-264 on day 1 of 3-week cycles as 30-minute intravenous infusions for up to 1 year or until disease progression or unacceptable toxicity. The primary objectives were to evaluate the safety profile including dose-limiting toxicities (DLTs) during cycle 1, determine the maximum tolerated dose (MTD), and characterize the PK profile of TAK-264. Results Twelve patients were enrolled and treated with 1.2 mg/kg (n=3), 1.5 mg/kg (n=3), or 1.8 mg/kg TAK-264 (n=6). Median number of treatment cycles received was two (range, 1 to 10). None of the patients experienced a DLT and the MTD was not determined. Ten patients (83%) experienced adverse events (AEs). The most common were neutropenia, anorexia, and nausea (each reported by four patients). Five patients (42%) experienced grade. 3 AEs consisting of tumor hemorrhage and hypertension, ascites, adrenal insufficiency, neutropenia and asthenia. Serum exposure to TAK-264 increased proportionally with the dose and the median half-life was approximately 5.5-6.6 days. No patients experienced an objective response. Conclusion TAK-264 demonstrated a manageable safety profile with limited antitumor activity consistent with studies conducted in Western patients with advanced GI malignancies. TAK-264 exposure increased proportionally with the dose. | - |
dc.language | 영어 | - |
dc.publisher | 대한암학회 | - |
dc.title | TAK-264 (MLN0264) in previously treated Asian patients with advanced gastrointestinal carcinoma expressing guanylyl cyclase C: Results from an open-label, non-randomized phase 1 study | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.4143/crt.2017.074 | - |
dc.citation.journaltitle | Cancer Research and Treatment | - |
dc.identifier.wosid | 000429484900010 | - |
dc.identifier.scopusid | 2-s2.0-85044942194 | - |
dc.citation.endpage | 404 | - |
dc.citation.number | 2 | - |
dc.citation.startpage | 398 | - |
dc.citation.volume | 50 | - |
dc.identifier.sci | 000429484900010 | - |
dc.identifier.kciid | ART002335460 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | HEAT-STABLE ENTEROTOXIN | - |
dc.subject.keywordPlus | COLORECTAL-CANCER | - |
dc.subject.keywordPlus | BRENTUXIMAB VEDOTIN | - |
dc.subject.keywordPlus | DRUG | - |
dc.subject.keywordPlus | CELLS | - |
dc.subject.keywordPlus | PROLIFERATION | - |
dc.subject.keywordPlus | RECEPTORS | - |
dc.subject.keywordPlus | LYMPHOMA | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | MARKER | - |
dc.subject.keywordAuthor | Clinical trial | - |
dc.subject.keywordAuthor | Gastrointestinal cancer | - |
dc.subject.keywordAuthor | Stomach | - |
- Appears in Collections:
- Files in This Item:
- There are no files associated with this item.
Item View & Download Count
Items in S-Space are protected by copyright, with all rights reserved, unless otherwise indicated.