Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010876-73 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGJ398 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGJ398 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD) | Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD). This will be calculated using an established statistical model, based on incidence of adverse events and serious adverse events, physical examinations, vital signs, electrocardiograms, and laboratory parameters | 23 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess preliminary anti-tumor activity of BGJ398 for patients in expansion Arm 4 (previously treated patients with advanced/metastatic UCC with FGFR3 gene alterations) | overall response rate (ORR), as assessed by investigator per RECIST v 1.0; overall survival (OS), duration of response (DOR) and disease control rate (DCR) will be assessed | 23 months |
Not provided
Inclusion Criteria:
Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists
Adequate bone marrow function
Adequate hepatic and renal function
Adequate cardiovascular function
Contraception.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Duarte | California | 91010 3000 | United States | ||
| Novartis Investigative Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| To determine the pharmacokinetic (PK) profiles of oral BGJ398 | Time vs. concentration profiles, PK parameters of BGJ398 and known active metabolite(s). | 23 months |
| To evaluate the pharmacodynamic effect of the drug. | Pre- vs. post treatment serial changes in FGF23 plasma levels (not done for patients enrolled to expansion Arm 4) | 23 months |
| Assess preliminary anti-tumor activity for patients not in Arm 4. | Overall tumor response rate (ORR) and PFS assessed by investigator per RECIST | 23 months |
| Los Angeles |
| California |
| 90033 |
| United States |
| Novartis Investigative Site | Los Angeles | California | 90095 | United States |
| University of Colorado Dept. of Anschutz Cancer (3) | Aurora | Colorado | 80045 | United States |
| Novartis Investigative Site | New Haven | Connecticut | 06520 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02114 | United States |
| Novartis Investigative Site | Detroit | Michigan | 48201 | United States |
| Memorial Sloan Kettering Cancer Center Onc. Dept.. | New York | New York | 10021 | United States |
| Novartis Investigative Site | New York | New York | 10029 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43221 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Hospital Onc Dept | Philadelphia | Pennsylvania | 19107-5098 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15232 | United States |
| Novartis Investigative Site | Memphis | Tennessee | 38120 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | United States |
| Novartis Investigative Site | Salt Lake City | Utah | 84103 | United States |
| Novartis Investigative Site | Heidelberg | Victoria | 3084 | Australia |
| Novartis Investigative Site | Vienna | A-1100 | Austria |
| Novartis Investigative Site | Bordeaux | 33075 | France |
| Novartis Investigative Site | Lyon | 69373 | France |
| Novartis Investigative Site | Marseille | 13273 | France |
| Novartis Investigative Site | Montpellier | 34298 | France |
| Novartis Investigative Site | Paris | 75015 | France |
| Novartis Investigative Site | Saint-Herblain Cédex | 44805 | France |
| Novartis Investigative Site | Suresnes | 92150 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Villejuif | 94805 | France |
| Novartis Investigative Site | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Marburg | 35039 | Germany |
| Novartis Investigative Site | Ramat Gan | 5265601 | Israel |
| Novartis Investigative Site | Tel Aviv | 6423906 | Israel |
| Novartis Investigative Site | Meldola | FC | 47014 | Italy |
| Novartis Investigative Site | Amsterdam | 1066 CX | Netherlands |
| Novartis Investigative Site | Amsterdam | 1081 HV | Netherlands |
| Novartis Investigative Site | Singapore | 169610 | Singapore |
| Novartis Investigative Site | Seoul | Korea | 05505 | South Korea |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Seville | Andalusia | 41013 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46009 | Spain |
| Novartis Investigative Site | Barcelona | 08041 | Spain |
| Novartis Investigative Site | Madrid | 28009 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Madrid | 28050 | Spain |
| Novartis Investigative Site | Taipei | 10048 | Taiwan |
| Novartis Investigative Site | Bangkok | 10330 | Thailand |
| Novartis Investigative Site | Chiang Mai | 50200 | Thailand |
| Novartis Investigative Site | Izmir | 35040 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C568950 | infigratinib |
Not provided
Not provided
Not provided