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JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00423

Registered date:14/05/2019

A Phase II trial of DS-8201a for HER2 positive biliary tract cancer

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHER2 positive biliary tract cancer
Date of first enrollment14/05/2019
Target sample size32
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention type:DRUG. Intervention1:DS-8201a, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, intended dose regimen:DS-8201a monotherapy.

Outcome(s)

Primary OutcomeOverall response rate in HER2 3+(IHC), or HER2 2+(IHC) and ISH positive patients by central imaging review. Timepoint:Weeks 6, 12, 18, 24, and every 12 weeks thereafter.
Secondary Outcome1)Overall response rate in all HER2-expressing patients by central imaging review 2)Overall response rate in HER2 low expressing patients by central imaging review 3)Overall response rate by local investigator review 4)Disease control rate 5)Progression-free survival 6)Overall survival 7)Incidence of adverse events . Timepoint: Tumor imaging: Weeks 6, 12, 18, 24, and every 12 weeks thereafter Safety: every 4 weeks .

Key inclusion & exclusion criteria

Age minimum>=20 YEARS
Age maximumNo Limit
GenderBOTH
Include criteria1.Adenocarcinoma or adenosquamous carcinoma is histologically diagnosed. 2.HER2-expressing was confirmed by central pathological examination of designated HER2 screening trial. HER2-expressing is defined as any of the following: 1)More than or equal to 1+ by IHC 2)Positive by ISH 3.Unresectable or recurrent biliary tract cancer. 4.No moderate or severe ascites. 5.There is no evidence of carcinomatous meningitis, symptomatic brain metastases, or spinal metastases requiring surgical intervention. 6.20 years or older. 7.The ECOG Performance status(PS) is either 0 or 1. 8.Measurable lesions are present. 9.Refractory or intolerant to treatment, including Gemcitabine. 10.Within 14 days prior to enrollment, the subject has not received systemic steroid therapy in excess of equivalent to 10 mg daily of prednisolone or immunosuppressive drugs. 11.Has not received anticancer drugs within 14 days before enrollment or any other investigational drugs within 21 days before enrollment. 12.Not undergoing surgery within 28 days prior to enrollment. 13.Has not received radiation therapy within 28 days prior to enrollment. 14.Left ventricular ejection fraction (LVEF) of > 50%. 15.The most recent test values within 14 days before enrollment meet all of the following: 1)Neutrophil count >= 1,500/mm3 2)Hemoglobin >= 9.0 g/dL 3)Platelet count >= 100,000/mm3 4)Total Bilirubin <= 1.5 mg/dL 5)AST <= 100 IU/L 6)ALT <= 100 IU/L 7)Creatinine clearance >= 30 mL/min 16.They have agreed to a contraceptive at least 4.5 months after the last administration of the investigational product. 17.Written informed consent.
Exclude criteria1.Having an active double cancer 2.Having a history/complication of symptomatic congestive heart failure within 6 months prior to enrollment or serious arrhythmias requiring treatment 3.Having a history/complication of myocardial infarction or unstable angina within 6 months prior to enrollment 4.Corrected QT interval (QTcF) > 470 ms (women) or QTcF > 450 ms (men) on 12-lead ECG 5.Having non-infectious interstitial lung disease or pneumonitis requiring steroid therapy. Complicated by interstitial lung disease or pneumonitis. Or these lung diseases cannot be ruled out by imaging during the screening period 6.Having uncontrolled infections that requiring IV injection of antibiotics, antivirals, or antifungal drugs 7.Positive for HIV antibodies, HTLV-1 antibodies, HBsAg, or HCV antibodies 8.Negative for HBsAg, positive for anti-HBs or anti-HBc, and positive HBV-DNA assay 9.Adverse events considered related to prior therapy that are not recovered to Grade 1 or less except alopecia 10.Hypersensitivity to the active ingredient of the investigational product has been confirmed 11.Women who are pregnant, breastfeeding, or who may be pregnant 12.Combined psychosis or psychiatric symptoms that are considered difficult to participate in the study 13.Because of drug allergy, neither iodine nor gadolinium drugs can be used.

Related Information

Contact

public contact
Name Naoko Matsui
Address Clinical Trial Management Section, Research Management Division, Clinical Research Support Office,5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Telephone +81-3-3542-2511
E-mail NCCH1805_HERB_office@ml.res.ncc.go.jpjp
Affiliation National Cancer Center Hospital
scientific contact
Name Chigusa Morizane
Address Department of Hepatobiliary and Pancreatic Oncology,5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Telephone +81-3-3542-2511
E-mail
Affiliation National Cancer Center Hospital