| Study Name |
|
Brightline-2 |
| ClinicalTrials.gov Identifier (if applicable) |
|
NCT05512377 |
| Clinical Trial Category (check all that apply) |
|
- Beyond First Line Therapy
- Targeted Therapy
|
| Study Center |
| Institution Name |
|
Tempus (TIME) Network (US only) |
| Country |
|
United States |
| List additional Institutions (include address, phone number, and website) |
|
|
Institution
|
PI
|
|
University of Wisconsin
|
Kratz, Jeremy
|
|
Sibley Memorial Hospital
|
Pishvaian, Michael
|
|
Memorial Sloan Kettering Cancer Center
|
Harding, James
|
|
University of Pennsylvania- Abramson Cancer Center
|
Karasic, Thomas
|
|
University of Michigan Health System-Michigan Medicine Main Location
|
Sahai, Vaibhav
|
|
Rocky Mountain Cancer Center
|
Cohn, Allen
|
|
Norton Healthcare Norton Cancer Institute- Louisville
|
Grewal, Jaspreet
|
|
Oregon Health and Science University,
|
Kardosh, Adel
|
|
Nebraska Cancer Specialists Suite
|
Natarajan, Nagendra
|
|
University of Southern California
|
El-Khoueiry, Anthony
|
|
Stanford Cancer Center
|
Chen, Christopher
|
|
MD Anderson Cancer
|
Javle, Milind
|
|
Precision NextGen Oncology
|
Sankhala, Kumar
|
|
NYU
|
Spencer, Kristen
|
|
| Study Contacts |
| Principal Investigator |
|
Tempus (TIME) Network (US only) |
| P.I. Email |
|
trials@tempus.com |
| Study Coordinator |
|
N/A |
| Study Coordinator Email |
|
trials@tempus.com |
| OVERVIEW – in layman’s terms (150 words max) |
|
This study is open to adults with advanced cancer in the biliary tract, pancreas, lung or urothelial in which an amplification of MDM2 and absence of mutations in TP53 have been identified in your tumor comprehensive genomic profile. |
| Enrollment |
|
Plan to enroll 100 subjects over approximately 2 years |
| Study Start Date |
|
11/11/2022 |
| Estimated Completion Date |
|
3/25/2027 |
| Purpose of the Study – in Layman’s Terms (use the “+” to add more list items) |
|
- To analyze efficacy and safety of BI 907828 in patients with advanced/metastatic MDM2 amplified/TP53wt biliary tract cancer (cholangiocarcinoma, gallbladder carcinoma, ampullary cancer). To analyze quality of life, PFS, OS, duration of response
|
| Inclusion Criteria – Patients Must: |
|
- Advanced/metastatic disease without approved treatment option MDM2 amplified / TP 53wt per local test
|
| Exclusion Criteria – Patients Must NOT: |
|
- Previous administration of BI 907828 or any other MDM2-p53 or MDMX (MDM4)-p53 antagonist
- Active bleeding, significant risk of haemorrhage (e.g. previous severe gastrointestinal bleeding, previous haemorrhagic stroke at any time), or current bleeding disorder (e.g. haemophilia, von Willebrand disease).
- Major surgery (major according to the investigator’s assessment) performed within 4 weeks prior to start of trial treatment or planned within 6 months after screening (e.g. hip replacement).
- Receiving treatment for brain metastases or leptomeningeal disease (LMD) which may interfere with safety and/or efficacy endpoint assessment.
|
| REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms |
|
- MDM2 amplification, TP53 wildtype
|
| POTENTIAL SIDE-EFFECTS – in layman’s terms |
|
- Myelosuppression (decrease of white and red cells and platelets. Gastrointestinal side effects: nausea, diarrhea, and vomiting)
|
