HER2 positive advanced gastric or gastro-esophageal junction cancer MedDRA version: 20.0 Level: PT Classification code 10001150 Term: Adenocarcinoma gastric System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Kanjinti
Product Code: [ABP 980]
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: TRASTUZUMAB
CAS Number: 180288-69-1
Current Sponsor code: ABP 980
Other descri
Sponsors
GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare PFS in patients receiving an oxaliplatin-based chemotherapy doublet (mFOLFOX6 or XELOX) combined with ABP 980 for HER2+ gastric or gastro-esophageal junction (GEJ) cancer to an historical control.;Secondary Objective: -To determine additional measures of clinical benefit, specifically, OS, TPP duration of response of an oxaliplatin-based chemotherapy doublet (mFOLFOX6 or XELOX) combined with ABP 980 in HER2+ gastric or gastro-esophageal junction (GEJ) cancer patients. It will be performed a comparison with an historical control; -To compare objective tumor response in term of CR or PR to an historical control; -To describe safety and QoL of an oxaliplatin-based chemotherapy doublet (mFOLFOX6 or XELOX) combined with ABP 980 in HER2+ gastric or gastro-esophageal junction (GEJ) cancer patients. Explorative objectives: -To describe the association between the outcome, experimental factor and sub-factors that may influence the clinical or pathological response (e.g.: sex, age, histological subtype, grading, tumor site, etc.);Primary end point(s): Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: 12 months after enrolling each patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS); Time to Progression (TTP); Complete Response (CR) or Partial Response (PR); Duration of Response (DOR); Safety profile; Quality of Life evaluation;Timepoint(s) of evaluation of this end point: 12 months after enrolling each patient; 12 months after enrolling each patient; Every 8 weeks; Every 8 weeks; From Informed consent signature to the end of treatment visit; At the screening, at each cycle of induction phase, at the end of the induction phase, at each cycle of maintenance phase, at the end of treatment, at follow up | — |
Countries
Italy
Contacts
Public ContactU.O. Oncologia
ASST di Cremona
Outcome results
None listed