NCT02970539

Ph1b Study of Oraxol in Comb. w. Ramucirumab in Patients w. Gastric, Gastro-esophageal, or Esophageal Cancers

A Phase 1b Study of Oraxol in Combination With Ramucirumab in Patients With Gastric, Gastro-esophageal, or Esophageal Cancers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Athenex, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a nonrandomized, open-label, single group assignment, safety, tolerability and pharmacokinetic (PK) study to determine the MTD and optimal dosing regimen of Oraxol in combination with ramucirumab.

Detailed description

This is a sequential-group, dose escalation trial to determine the maximum tolerated dose of oral Oraxol in combination with intravenous ramucirumab. After a screening period of up to 28 days subjects will be enrolled into the treatment phase of the study. Each cycle of therapy will last 4 weeks. Subjects may continue in the study until they experience disease progression or unacceptable toxicity. Three to six subjects will be enrolled at each dose level. Once the tolerability of a dose level has been determined, an additional 3-6 subjects may be enrolled at a higher dose level, to determine the maximum tolerated dose. Safety will be monitored through recording of adverse events, serious adverse events, monitoring of laboratory tests including hematology, blood chemistry, urinalyses, physical examinations and electrocardiograms. Subjects will undergo radiographic assessments for tumor response at specified time points. Blood samples will also be obtained in the first cycle of therapy at multiple time points for determination of the amount of paclitaxel and metabolites and HM30181 in the circulation. After the treatment period, there will be a follow-up period during which the subject or family may be contacted every three months for follow-up.

Conditions

• Gastric Cancer
• Esophageal Cancer
• Gastro-esophageal Cancer

Interventions

Type	Name	Description
DRUG	Oraxol	Oraxol (Paclitaxel and HM30181A) will be dosed orally. Paclitaxel will be supplied as capsules and HM30181A will be supplied as tablets.
DRUG	Ramucirumab	Ramucirumab will be administered by iv infusion and supplied as a solution at a concentration of 10 mg/mL

Timeline

• Start date: 2016-12-08
• Primary completion: 2019-03-27
• Completion: 2022-12-31
• First posted: 2016-11-22
• Last updated: 2022-02-16

Locations

5 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study