Health Trials

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

Qualifiers

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

Treatments tested in this trial

  • TRK-950
  • Ramucirumab
  • Paclitaxel

Treatment groups

146 Participants
are divided into 3 treatment groups

Locations

27
Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center241-8515, YokohamaKanagawa, Japan
Saitama Prefectural Hospital Organization Saitama Cancer Center362-0806, ShindenSaitama, Japan
Shizuoka Cancer Center411-8777, Nagaizumi-choShizuoka, Japan
National Cancer Center Hospital104-0045, Chūōku Japan

Sponsors and collaborators

Toray Industries, Inc

Lead sponsor

Source ClinicalTrials.gov