Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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