| Study Name |
|
A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy |
| ClinicalTrials.gov Identifier (if applicable) |
|
NCT02150967 |
| Study Center |
| Institution Name |
|
Novartis Pharmaceuticals |
| Institution Address |
|
One Health Plaza |
| City |
|
East Hanover |
| State |
|
New Jersey |
| Zip Code |
|
07936 |
| Phone |
|
(888) 669-6682 |
| Website |
|
https://www.novartis.com/ |
| Study Contacts |
| Principal Investigator |
|
TBD |
| P.I. Phone |
|
(888) 669-6682 |
| P.I. Email |
|
novartis.email@novartis.com |
| List additional Principal Investigators (include phone number and email) |
|
Please refer to the Clinical Trials.gov listing and contact Novartis at 1-888-669-6682 for a research center near you |
| Study Coordinator |
|
TBD |
| Study Coordinator Phone |
|
(888) 669-6682 |
| Study Coordinator Email |
|
novartis.email@novartis.com |
| List additional Study Coordinators (include phone number and email) |
|
Please refer to the Clinical Trials.gov listing and contact Novartis at 1-888-669-6682 for a research center near you |
| OVERVIEW – in layman’s terms (150 words max) |
|
This Phase II clinical trial will establish the effectiveness of BGJ398 in patients harboring the FGFR2 gene fusion/translocation, which are errors in the DNA. Adult patients with histologically or cytologically confirmed (tumor biopsy), advanced or metastatic cholangiocarcinoma harboring the FGFR2 gene fusion/ translocation are eligible for enrollment. Phase II clinical trials give doctors more information about the safety of the drug and how well it works.
Approximately 55 adult patients over age 18, both male and female will be enrolled. All patients will receive oral BGJ398, once daily, on a three weeks on (21 days), one week off (7 days) schedule |
| Enrollment |
|
Actively recruiting |
| Study Start Date |
|
07/14/2014 |
| Estimated Completion Date |
|
06/29/2020 |
| Purpose of the Study – in Layman’s Terms (use the “+” to add more list items) |
|
- Overall response rate
The Overall response rate is determined by the proportion of patients experiencing a Complete Response or those patients with a Partial Response.
|
| Inclusion Criteria – Patients Must: |
|
- Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the time of diagnosis
- Patients must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/ metastatic disease. Patient should have evidence of progressive disease following prior regimen, or if prior treatment discontinued due to toxicity must have continued evidence of measurable or evaluable disease.
|
| Exclusion Criteria – Patients Must NOT: |
|
- •Prior or current treatment with a MEK or selective FGFR inhibitor
- •insufficient organ function
|
