A Randomized, Multicenter, Open-Label, Phase 2 Study of TRK-950 When Used in Combination With Ramucirumab and Paclitaxel in Patients With Gastric Cancer
Toray Industries, Inc
Summary
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.
Description
This study will assess and compare the efficacy, safety, pharmacokinetics (PK), optimal dose and anti-drug antibodies (ADA) and neutralizing antibodies (NAbs) development of TRK-950 at two separate dose levels in combination with RAM + PTX as compared with RAM + PTX treatment alone in participants with gastric or gastro-esophageal junction (GEJ) adenocarcinoma. The primary objective is progression free survival (PFS). Secondary objectives are overall survival, objective response rate, best overall response, duration of response, disease control rate, safety, pharmacokinetics, and immunogenicit…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically confirmed metastatic, or locally advanced and unresectable gastric or GEJ adenocarcinoma. * The patient is eligible to receive Ramucirumab + Paclitaxel. * Documented objective radiographic or clinical disease progression (e.g., any new or worsening malignant effusion documented by ultrasound examination) which may be confirmed by pathologic criteria (histology and/or cytology) if appropriate, during or after treatment. The prior treatment must meet one of the following criteria with the following treatment history: 1. First treatment fo…
Interventions
- BiologicalTRK-950
5 mg/kg or 10 mg/kg IV infusion over 60 minutes on Day 1, 8, 15 and 21 of each 28 day cycle
- DrugRamucirumab
8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
- DrugPaclitaxel
80 mg/m\^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle
Locations (27)
- City of HopeDuarte, California
- City of Hope at Orange County Lennar Foundation Cancer CenterIrvine, California
- University of California, Los AngelesSanta Monica, California
- Texas Oncology Arlington NorthArlington, Texas
- Texas Oncology BedfordBedford, Texas
- Texas Oncology Dallas MethodistDallas, Texas