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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM201+LEE011 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM201 | Drug |
| ||
| LEE011 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) during the first cycle of treatment. | DLTs in the first cycle of treatment. | 5 years |
| Phase Ib: Exposure to HDM201 and LEE011 as measured by AUC 0-24h | as measured by AUC0-24h | 5 years |
| Phase II: Progression free survival (PFS) | To assess the preliminary anti-tumor activity of HDM201 in combination with LEE011 in liposarcoma | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib/II: Incidence and severity of AEs and SAEs | Run-in part to assess safety of HDM201 in combination with LEE011 | 5 years |
| Phase Ib/II: number of patients with dose interruptions and reduction |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Toronto | Ontario | M5G 2M9 | Canada | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CHDM201X2103C can be found on the Novartis Clinical Trial Results Website | View source |
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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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| ID | Term |
|---|---|
| D008080 | Liposarcoma |
| ID | Term |
|---|---|
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000654196 | siremadlin |
| C000589651 | ribociclib |
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|
Run-in part To assess tolerability of HDM201 in combination with LEE011
| 5 years |
| Phase Ib/II: dose intensity | Run-in part To assess tolerability of HDM201 in combination with LEE011 | 5 years |
| Phase Ib/II: Pharmacokinetics (PK) parameters of HDM201 and LEE011: Cmax | Run-in part to evaluate PK parameters of HDM201 and LEE011 | 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 | 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 | 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 | 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. | 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. | 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 | 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 | 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 | 5 years |
| Bordeaux |
| 33076 |
| France |
| Novartis Investigative Site | Lyon | 69373 | France |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Ulm | 89081 | Germany |
| Novartis Investigative Site | Singapore | 169610 | Singapore |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Madrid | 28222 | Spain |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| D012509 | Sarcoma |