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

NCT02970539 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-02-16

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Athenex, Inc.

    lead INDUSTRY

Principal Investigators

  • David Cutler, MD · Athenex, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-08
Primary Completion
2019-03-27
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States
  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02970539 on ClinicalTrials.gov