None listed
Conditions
Interventions
double-blind, 1:1 randomized. Study will evaluate efficacy of IMAB362 plus mFOLFOX6 versus placebo plus mFOLFOX6 as first-line treatment Type of group
The investigational product, IMAB362, is a sterile lyophilized powder preparation with the chimeric monoclonal antibody IMAB362 as the active pharmaceutical ingredient. Each vial contains 105 mg of IMAB362 and has to be reconstituted with 5.0 mL sterile water for injection, USP to a concentration of 20 mg/mL. Further dilution with sterile 0.9% Sodium Chloride Injection, USP to a final concentration of 2 mg/mL is required. Placebo: sites should use 0.9 % Sodium Chloride Injection, USP as placebo.
e.g., C1D1). Intravenous (IV) infusion of IMAB362/placebo as a 2-hour infusion. IV infusion may be interrupted or slowed down to manage toxicity. It is recommended that IMAB362/placebo infusion not ex
Sponsors
Astellas Pharma Global Development, Inc. (APGD),
Eligibility
Inclusion criteria
Inclusion criteria: 1. IRB /EC Approved written ICF must be obtained from subject or legally authorized representative( if applicable)prior to ay study related procedute 2.Subject ≥ 18 years of age 3.Subject agrees not to participate in another interventional study while on study treatment. 4.Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 6 months after the final study treatment administration 5.Female subject must not donate ova starting at Screening and throughout the study period, and for 6 months after the final study drug administration. 6.Male subject must not donate sperm starting at Screening and throughout the study period and for 6 months after the final study drug administration. 7.Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or for the time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration. ( see more criterios in the protocol)
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 neoadjuvant 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 received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to first dose of study treatment. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone) are allowed. 4. Subject has received other investigational agents or devices within 28 days prior to first dose of study treatment. ( see more criterios in the protocol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary efficacy endpoint of PFS will be analyzed using the stratified Log Rank Test with stratification factors to be specified in the SAP. The hypothesis testing on the primary analysis will be performed at an overall 1-sided 0.025 significance level to test the null hypothesis that PFS is not prolonged in Arm A compared to Arm B versus the alternative hypothesis that PFS is prolonged in Arm A compared to Arm B. Estimates of the treatment effect will be expressed as Hazard Ratio (HR) using a stratified Cox model, including 95% Confidence Interval (CI). The sensitivity analysis for the primary efficacy endpoint will also be performed Measure:PFS, defined as the time from the date of randomization until the date of radiological Progression Disease (per RECIST 1.1 by IRC) or death from any cause, whichever is earliest Timepoints:Progression Free Survival (PFS) [ Time Frame: Up to 13 months ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:will be analyzed using the stratified Log Rank Test with the same strata used in the analysis of PFS. To maintain the overall Type I error rate at the 0.025 significance level, the hypothesis testing on OS will be performed only if the null hypothesis on the primary analysis is rejected at the overall 1-sided 0.025 significance level. The sensitivity analysis for the key secondary endpoint will be performed on the PPS. The secondary efficacy endpoint of ORR will be analyzed using the Cochran-Mantel-Haenszel (CMH) test to control for the same strata used in the analysis of PFS and OS. The secondary HRQoL endpoints collected via the EORTC QLQ-C30 and QLQ-OG25, GP and EQ5D- 5L will be analyzed with summary of change from baseline over time through the end of mFOLFOX6 treatment and inferential methods. Detailed analysis of HRQoL endpoints will be provided in the SAP. Measure:OS, defined as the time from the date of randomization until the date of death from any cause ORR, defined as the proportion of subjects who have a best overall response (BOR) of CR or PR as assessed by IRC per RECIST 1.1 DOR, defined as the time from the date of the first response (CR/PR) until the date of PD as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest Safety and tolerability, as measured by AEs, laboratory test results, vital signs, ECGs, and ECOG performance status HRQoL, as collected via EORTC QLQ-C30, QLQ-OG25, GP and EQ5D-5L questionnaires Pharmacokinetics of IMAB362, Cmaxand Ctrough Immunogenicity of IMAB362 as measured by the frequency of anti-drug antibody (ADA) positive subjects Timepoints:Overall Survival (OS) [ Time Frame: Up to 23 months Objective Response Rate (ORR) [ Time Frame: Up to 13 months ] Duration Of Response (DOR) [ Time Frame: Up to 13 months ] Safety and tolerability assessed by adverse events (AEs) [ Time Frame: Up to 16 months Number of | — |
Countries
Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, France, Germany, Israel, Italy, Japan, Korea North, Korea South, Mexico, Poland, Spain, Taiwan, United Kindgdom, United States
Contacts
Public ContactRosmery Osorio
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed