A Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorToray Industries, Inc
About this trial
This study will assess the efficacy, safety, optimal dose and ADA and NAbs development of TRK-950 at two separate dose levels in combination with ramucirumab and paclitaxel (RAM+PTX) as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed metastatic, or locally advanced and unresectable gastric or GEJ adenocarcinoma.
The patient is eligible to receive Ramucirumab + Paclitaxel.
First treatment for metastatic disease or locally advanced disease without experiencing adjuvant / neo-adjuvant treatment, which progressed during treatment or within 4 months after the last dose of treatment
Adjuvant / neo-adjuvant treatment which progressed more than 6 months after the last dose of treatment and first treatment for metastatic disease or locally advanced disease, which progressed during the treatment or within 4 months after the last dose of treatment
Disqualifiers
Prior history of treatment with ramucirumab or paclitaxel.
HER2 positive gastric or GEJ adenocarcinoma.
Major surgery within 28 days prior to randomization.
Baseline corrected QT (QTc) interval of > 470 msec for females and > 450 msec for males calculated using Fridericia's formula.
Trial design
Design model
Parallel
Treatments tested in this trial
TRK-950
Biological/Vaccine5 mg/kg or 10 mg/kg IV infusion over 60 minutes on Day 1, 8, 15 and 21 of each 28 day cycle
Ramucirumab
Drug8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
Paclitaxel
Drug80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle
Treatment groups
146 Participants
are divided into 3 treatment groupsGroup A: Arm A: TRK-950(5 mg/kg)+Ramucirumab+PaclitaxelExperimental treatment 3 interventions
Group B: Arm B: TRK-950(10 mg/kg)+Ramucirumab+PaclitaxelExperimental treatment 3 interventions
Group C: Arm C: Ramucirumab+PaclitaxelActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Progression free Survival (PFS)
Progression free Survival (PFS) is defined as time from the date of randomization to the date of progressive disease or death due to any cause based on Independent Central Review.
Time frame
Time from date of randomization to the date of progressive disease or death due to any cause, whichever occurs first, up to approximately 24 monthsSecondary outcomes
1
Overall survival (OS)
Overall survival is defined as the time from the date of randomization to the date of death due to any cause.
Time frame
Time from the date of randomization to the date of death due to any cause, up to approximately 24 months2
Objective response rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Independent Central Review.
Time frame
From start of treatment to date of documented disease progression, up to approximately 24 months3
Progression free Survival (PFS)
Progression free Survival (PFS) is defined as time from the date of randomization to the date of progressive disease or death due to any cause based on investigator assessment.
Time frame
Time from date of randomization to the date of progressive disease or death due to any cause, whichever occurs first, up to approximately 24 months4
Objective response rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants who achieve a best overall response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by investigator.
Time frame
From start of treatment to date of documented disease progression, up to approximately 24 monthsSponsors and contacts
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Source ClinicalTrials.gov