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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004131-20 | EudraCT Number |
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A two part study to determine the maximum tolerated dose and/or recommended phase 2 dose of PDR001 in combination with sorafenib in patients with advanced hepatocellular carcinoma in first line. There will be a dose escalation part and a dose expansion part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDR001 + Sorafenib | Other | PDR001 at 400 mg given intravenously every 4 weeks and sorafenib 400 mg taken orally once or twice per day (escalating doses) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDR001 | Drug | PDR001 will be administered intravenously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Incidence and severity of AEs and SAEs, including changes in laboratory vital signs and ECGs | From baseline until 30 days of last dose of study treatment |
| Incidendence of Dose Limiting Toxicities (DLTs) | A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol. | During the first 8 weeks of treatment |
| Dose interruptions | Tolerability measured by the number of subjects who have interruptions of study treatment | Until end of treatment, assessed for a median time of 4 months |
| Dose reductions | Tolerability measured by the number of subjects who have reductions of study treatment | Until end of treatment, assessed for a median time of 4 months |
| Dose intensity | Tolerability measured by the dose intensity of study treatment | Until end of treatment, assessed for a median time of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as per central radiology assessment by dose level | Overall response rate (ORR) as per the independent central radiology assessment will be summarized descriptively by dose level. The overall response rate (ORR) is defined as the proportion of patients with best overall response of CR or PR. The best overall response is the best response recorded using the independent central radiology review based on RECIST 1.1 from start of treatment until disease progression, death, start of new therapy, withdrawal of consent or cut-off date, whichever occurs first |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CPDR001G2101 from Novartis Clinical Trials Website | View source |
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| Sorafenib |
| Drug |
Sorafenib is formulated as a tablet. |
|
| Until end of treatment, assessed for a median time of 4 months |
| PDR001 trough concentration | Concentration of PDR001 in plasma | Pre-dose at Cycle 2, 3, 4, 6 , 8, 10, 12 on Day 1. Cycle=28 days |
| Maximum concentration (Cmax) of sorafenib | The maximum (peak) observed plasma, drug concentration after single dose administration. | Cycle 3 Day 1 Pre-dose, 1h, 3h and 8 h post-dose. Cycle=28 days |
| Time to reach maximum concentration (Tmax) of sorafenib | The time to reach maximum (peak) plasma drug concentration after single dose administration (time) | Cycle 3 Day 1 Pre-dose, 1h, 3h and 8 h post-dose. Cycle=28 days |
| Area under the plasma concentration-time curve of sorafenib from time zero to 8 hours after administration (AUC0-8) | Area under the plasma concentration-time curve of sorafenib from time zero to time 't' where t is a defined time point after administration. t=8 hours (AUC0-8) | Cycle 3 Day 1 Pre-dose, 1h, 3h and 8 h post-dose. Cycle=28 days |
| Area Under the Plasma Concentration-time Profile (AUCtau) of sorafenib | Area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady-state | Cycle 3 Day 1 Pre-dose, 1h, 3h and 8 h post-dose. Cycle=28 days |
| Montreal |
| Quebec |
| H3T 1E2 |
| Canada |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Hong Kong | Hong Kong |
| Novartis Investigative Site | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Kashiwa | Chiba | 277 8577 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 232 0024 | Japan |
| Novartis Investigative Site | Pamplona | Navarre | 31008 | Spain |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000711728 | spartalizumab |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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