Gastric Neoplasm malignant MedDRA version: 15.0 Level: HLT Classification code 10017812 Term: Gastric neoplasms malignant System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Removab
Product Name: catumaxomab (INN)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: catumaxomab
CAS Number: 509077-98-9
Concentration unit: µg microgram
Sponsors
Fresenius Biotech GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent 2. Male or female patient at an age of 18 years or older 3. Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3) 4. TNM-staging at screening of T2/T3/T4, N+/-, M0 5. Intended curative subtotal or total gastrectomy ('en-bloc'-R0-resection considering the standard D2-scheme) 6. Karnofsky index >= 70 7. Negative pregnancy blood test at screening but not more than 72 hours prior to the start of chemotherapy, for women of childbearing potential 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Exposure to prior cancer therapy (surgery, chemo- or radio-therapy) or planned adjuvant chemo- or radiotherapy of the current gastric cancer before "End-of-Treatment" visit (EOT = 1 month after last catumaxomab administration) 2. Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except cervix carcinoma in situ and adequately treated non-melanomatous skin cancer) 3. Previous use of non-humanized monoclonal mouse or rat antibodies 4. Known or suspected hypersensitivity or allergy to catumaxomab or to similar antibodies or to any of the planned ECX chemotherapeutic drugs 5. Known dihydropyrimidine-dehydrogenase (DPDH) deficiency 6. Known contraindications to any of the planned ECX-chemotherapeutics 7. Presence of distant metastases 8. Presence of constant immunosuppressive therapy 9. Presence of bilateral pleural effusion or hypalbuminemia associated with hypovolemia and hypotension 10. Presence of symptomatic pyloric stenosis (defined as excessive vomiting and weight loss > 10% within the last 3 months) 11. Presence of any acute or chronic systemic infection 12. Presence of a bowel obstruction within the last 30 days 13. Pre-existing heart failure > NYHA class II 14. Inadequate renal function (Creatinine >1.5 x ULN or Creatinine Clearance 2.5 x ULN or Bilirubin > 1.5 x ULN) 16. Inadequate bone marrow function with Platelets < 100 000 cells/mm3 or absolute neutrophil count (ANC) < 1500 cells/mm3 17. Left ventricular ejection fraction (LVEF) below normal institutional ranges as measured by echocardiogram or any clinically significant abnormality detected by echocardiogram 18. Pregnant or nursing woman, or woman of childbearing potential who is not using an adequate and effective contraceptive method during the study and at least three months after the last i.p.-infusion (i.e., oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms) 19. Any further condition which according to the investigator results in an undue risk to the patient during participation in the present study 20. The patient planned to be enrolled is an employee of any involved study investigator or of any involved institution including the study sponsor 21. Parallel participation in another clinical trial or previously in this study 22. Treatment with another investigational product during this study or during the last 30 days prior to study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subsequent to a neoadjuvant chemotherapy. Relevant efficacy parameters (e.g., DFS, OS) will be assessed during a post-treatment follow-up period of two years.;Secondary Objective: Secondary safety endpoints: - Frequency, relationship and seriousness of adverse events (AEs) - Clinically relevant laboratory results (hematology with differential blood count, clinical chemistry, coagulation tests and determination of cytokines, procalcitonin, and anti-catumaxomab antibodies by DABA) - Vital functions (SBP/DBP, HR, T°) Efficacy endpoints: - Surgical resection rate - Chemotherapeutic response rate (using the RECIST-guidance) - Overall survival (OS) defined as the time from study enrolment until death - Disease-free survival (DFS) defined as the time from study enrolment to the point of diagnosis of recurrent disease or death, whatever occurred first;Primary end point(s): The primary study endpoint will be the rate of all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least one dose of catumaxomab. The events below will be regarded as specific postoperative complications: ?- Any death ?- Any abscess requiring an intervention (e.g., surgery or drainage) ?- Symptomatic cholecystitis verified by ultrasound or CT-scan ?- Symptomatic pancreatitis verified by CT-scan and at least one of the following objective diagnostic measurements/measures: - Serum amylase > = 3 x ULN - Serum lipase > = 3 x ULN ?- Pulmonary infection verified by chest X-ray or CT-scan ?- Abdominal hemorrhage requiring any therapy ?- Anastomosis insufficiency requiring surgery ?- Ileus with grade IV clinical symptoms or requiring any surgical therapy ?- Thromboembolism verified by at least one of the follow | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety endpoints: - Frequency, relationship and seriousness of adverse events (AEs). ?- Clinically relevant laboratory results (hematology with differential blood count, clinical chemistry, coagulation tests and determination of cytokines, procalcitonin, and anti-catumaxomab antibodies by DABA) ?- Vital functions (SBP/DBP, HR, T°) Efficacy endpoints: ?- Surgical resection rate ?- Chemotherapeutic response rate (using the RECIST-guidance) ?- Overall survival (OS) ?- Disease-free survival (DFS) ;Timepoint(s) of evaluation of this end point: Safety: All AEs until EOT. Labaratory results: Pre-treatment at screening, pre-infusion of the day of surgery and of the postoperative days 7, 10, 13 and 16 prior to i.p.-infusion. Vital functions: Pre-treatment at screening, pre-infusion of the day of surgery prior to operation and of the postoperative days 7, 10, 13 and 16 prior to the i.p.-infusion. Efficacy endpoints: ?- Overall survival (OS) at 3, 6, 9, 12, 18 and 24 months after EOT, time from study enrolment until death ?- Disease-free survival (DFS) at 3, 6, 9, 12, 18 and 24 months after EOT, time from study enrolment to the point of diagnosis of recurrent disease or death, whichever occurred first | — |
Countries
Austria, Germany, Russian Federation, United Kingdom
Contacts
Public ContactMedical Information
Fresenius Biotech GmbH
Outcome results
None listed