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

• Status: Completed
• Trial end date: 2019-10-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.