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The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol

NCT03892018 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-05-22

No results posted yet for this study

Summary

This is multicenter, open-label, 2-part crossover study. Eligible subjects will have metastatic or unresectable solid tumors. This study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline. The treatment phase consists of Periods 1 and 2 (Part A), Treatment (Part B), and Follow-up.

Conditions

  • Solid Tumor, Adult

Interventions

DRUG

Oraxol

Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets.

Sponsors & Collaborators

  • Athenex, Inc.

    lead INDUSTRY

Principal Investigators

  • David Cutler, MD · Athenex, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-05
Primary Completion
2023-05-12
Completion
2023-05-12
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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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 NCT03892018 on ClinicalTrials.gov