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

Sponsored by Novartis Pharmaceuticals

About this trial

Last updated 5 years ago

Study ID

CHDM201X2103C

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 years ago

What is this trial 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.

What are the participation requirements?

Yes

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

No

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.

Locations

Location

Status