plus cisplatin for HER2-positive biliary tract cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0003158
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion criteria related to disease
1.The subject with disease that is not amendable to a curative treatment approach or locally advanced or metastatic or unresectable CCC(Cholangiocarcinoma) with histological diagnosis
2.At least one measurable(per RECIST 1.1) lesion
3.Primary or metastatic tumor with HER2 positive defined on IHC2+, FISH+ or IHC3+
4.ECOG Performance status 0 or 1
5.At least 3 months for life expectancy
Common inclusion criteria
6.Men or women over 19 years at time of signing ICF(Informed Consent Form)
7.Signed Informed Consent Form
Exclusion criteria related to tumor
8.Received prior chemotherapy for advanced/metastatic disease (the adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrolled will be accepted)
9.Not recovery from toxicities related to any prior treatments excluding alopecia (eg, neurological toxicity to = Grade 2)
10.History of malignancy other than CCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death, such as carcinoma in situ or thyroid papillary carcinoma
Hematology, chemistry or organ function
11.ANC < 1.5 × 109/L, or Platelet < 100 × 109/L
12.Total bilirubin > 1.5 × ULN; or AST/ ALT > 2.5 × ULN (Upper Limit of Normal or if the tumor has expanded into the liver, > 5 × ULN); or, alkaline phosphatase > 2.5 × ULN (or > 5 × if the tumor has expanded into the liver, or > 10 × ULN if the tumor has expanded into the brain without liver,); or albumin < 2.5 g/dL
13.Creatinine clearance < 60 mL/min(calculated using the Cockcroft-Gault formula)
Other exclusion criteria related to IP(Investigational Product)
14.History of proved congestive heart failure; angina with medication; evidence of transmural myocardial infarction on ECG; uncontrolled hypertension(systolic> 180 mmHg or diastolic> 100 mmHg); clinically significant heart valve disease; uncontrolled arrhythmia
15.LVEF(Left Ventricular Ejection Fraction) < 50% (calculated by cardiac sonography or MUGA(MUltiGAted acquisition)
16.Subject with rest dyspnea due to metastatic tumor or other disease or who needs oxygen therapy
17.Chronic or high-dose corticosteroid treatment
18.Clinically significant Hearing impairment
Common exclusion criteria
19.History or evidence of CNS(Central Nervous System) metastases
20.Interstitial pneumonia or pulmonary fibrosis with symptom and exact lesion on chest X-ray
21.Hearing loss
22.Uncontrolled significant systemic disease (eg, infection or uncontrolled DM-Diabetes Mellitus)
23.Pregnant or lactating females
24.Sexually active fertile subjects without contraception
25.Treatment with other investigational therapy within 4 weeks prior to initiation of study treatment
26.Radiotherapy within 4 weeks prior to initiation of study treatment (the rest at least 2 weeks after palliative radiotherapy for bone metastasis and recovery from the effects of radiation will be accepted.)
27.Major surgery within 4 weeks prior to initiation of study treatment
28.History of HIV((human immunodeficiency virus) and active HBV(Hepatitis B virus) or HCV(Hepatitis C virus)
29.Previously identified allergy or hypersensitivity to components of the study treatment formulations
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate
- Secondary Outcome Measures
Name Time Method duration of response;time to progressio disease;Progression-free survival;Overall survival;safety