Neoplasms

All Conditions

Rare Diseases

Liposarcoma

Neoplasms, Adipose Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

HDM201

LEE011

Novartis Pharmaceuticals

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.

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

A Phase Ib/II, Open-label, Multicenter Study of Oral HDM201 in Combination With Oral LEE011 in Adult Patients With Liposarcoma

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

To assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma

Run-in part to assess safety of HDM201 in combination with LEE011

Run-in part To assess tolerability of HDM201 in combination with LEE011

Run-in part to evaluate PK parameters of HDM201 and LEE011

Run-in part to evaluate the PK parameters of HDM201 and LEE011

Run-in part measure of GDF-15 fold-change in protein levels (PD direct targets of p53) to assess PD changes from baseline in blood and a potential relationship with clinical outcome.

Run-in part measure of p21 and MDM2 protein levels by IHC (H-Score) (p53 and CDK4 pathways) to assess changes from baseline of PD markers in tumor tissue and a potential relationship with clinical outcome.

Run-in part to assess PD effect of HDM201 and LEE011 and a potential relationship with clinical outcome

Run-in part to assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma

Run-in part to further assess the anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma	NCT02343172	Liposarcoma	HDM201 LEE011	18 Years -	Novartis
Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma	NCT02343172	Liposarcoma	HDM201 LEE011	18 Years -	Novartis
Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma	NCT02343172	Liposarcoma	HDM201 LEE011	18 Years -	Novartis

Spots Global Cancer Trial Database for mdm2 inhibition