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
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 groupsSponsors and collaborators
Source ClinicalTrials.gov