Study of chemotherapy combined with ABP 980 in patients with advanced cancer of stomach or gastro-esophageal junction HER2-positive
- Conditions
- HER2 positive advanced gastric or gastro-esophageal junction cancerMedDRA version: 20.0Level: PTClassification code 10001150Term: Adenocarcinoma gastricSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-004357-86-IT
- Lead Sponsor
- GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 80
1.Males or females = 18 years old with ECOG performance status (PS) of 0 or 1,
2.Written, signed consent for trial participation must be obtained from the patients appropriately in accordance with applicable ICH guidelines and local and regulatory requirements prior to the performance of any study specific procedures;
3.Histological confirmed diagnosis of GC or GEJ adenocarcinoma
4.Radiolological confirmed locally advanced unresectable or metastatic disease within 28 days prior to the first dose of study treatment
5.Measurable disease according to RECIST 1.1. within 28 days prior the first dose of study treatment. For subjects with only one measurable lesion and prior radiotherapy, the lesion mus be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
6.Tumor HER2 overexpressing, as determined by local testing on a gastric or GEJ tumor specimen. For the purpose of this study, HER-2 overexpression is evaluated with IHC test, followed by ISH when IHC result is equivocal (2+). Positive (3+) or negative (+ or 1+) HER2 IHC results do not require further ISH test.
7.Left ventricular ejection fraction (LVEF) of =55% by 2D echocardiogram
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1.Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy as long as it was completed at least 6 months prior to the first dose of study treatment.
2.Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma unless the radiotherapy was completed within 28 days prior to start of study treatment. Subject who received palliative radiotherapy to peripheral bone metastases = 14 days prior to start of study treatment and has recovered from all acute toxicities is allowed.
3.Subject has a cardiac dysfunction conditioning a LVEF < 55%;
4.Subject has other significant cardiovascular disease, including:
-Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to administration of first dose of study drug.
-History of clinically significant ventricular arrhythmias (i.e., sustained ventriculal tachycardia, ventricular fibrillation Torsades de Pointes);
-QTc interval > 450 msec
-Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to first dose of study drugs are eligible)
5.Subject has known peripheral sensory neuropathy > Grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method