NCT03817411

Telatinib in Combination With Capecitabine/ Oxaliplatin in 1st Line Gastric or GEJ Cancer

A Phase II Randomized Trial of Telatinib in Combination With Capecitabine/Oxaliplatin Versus Capecitabine/Oxaliplatin as First-Line Therapy in Patients With HER2-negative Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Taizhou EOC Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to compare the combination regimen of Telatinib and Capecitabine and Oxaliplatin vs. Capecitabine and Oxaplatin to explore superiority of the Telatinib combination in terms of progression-free survival (PFS) in patients previously untreated for advanced HER2 negative advanced gastric or Gastroesophageal Junction adenocarcinoma.

Detailed description

This trial is a Phase 2, prospective, double-blind, randomized, comparative, multicenter trial in patients with advanced HER2 negative adenocarcinoma of the stomach or Gastroesophageal Junction which has progressed after resection and adjuvant or neoadjuvant therapy, or is unresectable or metastatic at time of first diagnosis. a total of approximately 90 patients will be enrolled and randomized into Telatinib combined with Capecitabine and Oxaliplatin or chemotherapy combined with placebo. All patients will be treated until progressive disease (radiologically documented or symptomatic deterioration) or the occurrence of unacceptable toxicity, withdrawal of consent or investigator's judgment.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Telatinib	300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.
DRUG	Capecitabine	1000 mg/m²,twice daily for 14 days followed by a 7-day rest period (14 days on/7 days off schedule).
DRUG	Oxaliplatin	130 mg/m2, administered intravenously over 2 hours, on Day 1 every 3 weeks (one administration per cycle) for a maximum of 6 cycles.
DRUG	Placebos	300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.

Timeline

• Start date: 2019-01-25
• Primary completion: 2020-03-30
• Completion: 2021-01-25
• First posted: 2019-01-25
• Last updated: 2019-05-07

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study