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A Study to Evaluate the Safety, Tolerability, MTD, PK, and Activity of Oraxol in Subjects w Adv. Malignancies

NCT02730481 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-09-13

No results posted yet for this study

Summary

This is a multicenter, open-label, safety study. Eligible subjects will be adults with advanced malignancies. The study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline periods. The treatment phase consists of 4-week treatment periods and a follow-up period.

Conditions

Interventions

DRUG

Oraxol

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

Sponsors & Collaborators

  • Athenex, Inc.

    lead INDUSTRY

Principal Investigators

  • E D Kramer, MD · Kinex Pharmaceuticals Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2021-03-31
Completion
2021-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02730481 on ClinicalTrials.gov