MedTrace Logo

Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours

NCT03894540 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-09-13

Study results available
· View outcomes & findings →

Summary

The purpose of the protocol is to determine safety, tolerability, recommended dose (RD), pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumour activity of IPN60090 as a single agent (Part A) and in combination with pembrolizumab (Part B) or paclitaxel (Part C) in patients with advanced solid tumours and to evaluate food effect (Part D).

Conditions

Interventions

DRUG

IPN60090

Oral capsules given daily

DRUG

pembrolizumab

An intravenous solution in single-use vial to be diluted for infusion.

DRUG

paclitaxel

An intravenous solution in single-use vial to be diluted for infusion.

DRUG

IPN60090 single administration

Oral capsules given once

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-22
Primary Completion
2020-12-21
Completion
2020-12-21
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 NCT03894540 on ClinicalTrials.gov