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Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma

NCT ID: NCT02343172

Last Updated: 2020-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-13

Study Completion Date

2019-10-16

Brief Summary

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To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.

Detailed Description

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Conditions

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Liposarcoma

Keywords

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Liposarcoma MDM2 inhibition cdk4 inhibition HDM201 LEE011

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HDM201+LEE011

Group Type EXPERIMENTAL

HDM201

Intervention Type DRUG

LEE011

Intervention Type DRUG

Interventions

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HDM201

Intervention Type DRUG

LEE011

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with histologically documented, locally advanced or metastatic WD/DD liposarcoma who have received at least one prior systemic therapy
* Patients with radiologic progression, defined by RECIST v.1.1, occurring while on/or within 6 months after last systemic treatment, prior to enrollment
* ECOG performance status of 0-1

Exclusion Criteria

* Prior treatment with compounds with the same mode of action
* Patients with TP53 mutated tumors, if the molecular status is known
* Symptomatic central nervous system metastases
* Inadequate organ function
* Previous and concomitant therapy that precludes enrollment, as defined by protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Bordeaux, , France

Site Status

Novartis Investigative Site

Lyon, , France

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Ulm, , Germany

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Countries

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United States Canada France Germany Singapore Spain Taiwan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17708

Results for CHDM201X2103C can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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CHDM201X2103C

Identifier Type: -

Identifier Source: org_study_id