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

Novartis

Status and phase: Completed; Phase 1

Conditions: Liposarcoma

Treatments: Drug: HDM201; Drug: LEE011

Study type: Interventional

Funder types: Industry

Identifiers

NCT02343172

CHDM201X2103C

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

HDM201+LEE011

Experimental group

Treatment:

Drug: HDM201

Drug: LEE011