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Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors

NCT03588039 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-05-19

No results posted yet for this study

Summary

This is an open-label, Phase 1 dose-escalation study followed by a 2-arm expansion cohort of Oraxol administered in combination with pembrolizumab.

Conditions

Interventions

DRUG

Oraxol

Oral paclitaxel will be supplied in capsules and oral HM30181AK-US will be supplied in tablets

BIOLOGICAL

Pembrolizumab

Intravenously administered

Sponsors & Collaborators

Principal Investigators

  • David Cutler, MD · Sr. Vice President of Clinical Development

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2023-05-12
Completion
2023-05-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03588039 on ClinicalTrials.gov