A Phase 1 interventional study of HDM201 and LEE011 in Liposarcoma, sponsored by Novartis Pharmaceuticals. Completed at 9 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-09.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
143 studies on the registry are indexed under Liposarcoma; 37 are open to participants now.
This study's enrollment of 74 is above the median of 40 across 119 interventional studies indexed under Liposarcoma.
Browse Liposarcoma studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Drug: HDM201 · Drug: LEE011
Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) during the first cycle of treatment.
DLTs in the first cycle of treatment.
Time frame: 5 years
Phase Ib: Exposure to HDM201 and LEE011 as measured by AUC 0-24h
as measured by AUC0-24h
Time frame: 5 years
Phase II: Progression free survival (PFS)
To assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma
Time frame: 5 years
Phase Ib/II: Incidence and severity of AEs and SAEs
Run-in part to assess safety of HDM201 in combination with LEE011
Time frame: 5 years
Phase Ib/II: number of patients with dose interruptions and reduction
Run-in part To assess tolerability of HDM201 in combination with LEE011
Time frame: 5 years
Phase Ib/II: dose intensity
Run-in part To assess tolerability of HDM201 in combination with LEE011
Time frame: 5 years
Phase Ib/II: Pharmacokinetics (PK) parameters of HDM201 and LEE011: Cmax
Run-in part to evaluate PK parameters of HDM201 and LEE011
Time frame: 5 years
Phase Ib/II: Pharmacokinetics (PK) parameters of HDM201 and LEE011: Tmax
Run-in part to evaluate the PK parameters of HDM201 and LEE011
Time frame: 5 years
Phase Ib/II: Pharmacokinetics (PK) parameters of HDM201 and LEE011: AUClast
Run-in part to evaluate the PK parameters of HDM201 and LEE011
Time frame: 5 years
Phase Ib/II: Pharmacokinetics (PK) parameters of HDM201 and LEE011: AUCtau
Run-in part to evaluate the PK parameters of HDM201 and LEE011
Time frame: 5 years
Phase Ib/II: Changes from baseline of Pharmacodynamics (PD) markers in blood (GDF-15)
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.
Time frame: 5 years
Phase Ib/II: Changes from baseline of Pharmacodynamics (PD) markers in tumor tissue (p21, MDM2)
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.
Time frame: 5 years
Phase Ib/II: anti-tumor activity endpoint (BOR, PFS)
Run-in part to assess PD effect of HDM201 and LEE011 and a potential relationship with clinical outcome
Time frame: 5 years
Phase Ib: BOR, ORR and PFS as per RECIST v1.1, assessed by investigator
Run-in part to assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma
Time frame: 5 years
Phase II: BOR, ORR and PFS as per RECIST v1.1, assessed by investigator
Run-in part to further assess the anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma
Time frame: 5 years
Plan to share: Undecided — 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
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals