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BI 907828 for Advanced Cancer
Study Summary
This trial is testing a new cancer drug, BI 907828, to see if it's effective and safe. Participants will take BI 907828 either once every three weeks or twice every four weeks, depending on how well they tolerate the drug. The goal is to see if BI 907828 causes tumors to shrink.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- No standard treatments are suitable or available for my condition.I have NSCLC, urothelial, gastric, biliary tract, or pancreatic cancer with specific genetic features and have received at least one treatment for advanced disease.My cancer can be measured by tests or seen on scans.I am willing to have blood tests for research purposes.I have a history of unusual bleeding or clotting.I am willing to have a tumor biopsy and blood tests for study purposes.I am willing to provide a new tumor sample after my cancer has worsened.I have not taken BI 907828 or similar drugs targeting MDM2-p53 or MDMX-p53.My tumor has a TP53 mutation.I haven't had major surgery in the last 3 months and don't plan any in the next year.I haven't had any cancer except for certain skin cancers or cervical cancer in the last 3 years.My sarcoma is MDM2 amplified and I need first line treatment.I have MDM2 amplified sarcoma and meet one of the previous criteria.My tumor is either TP53 wild type or its TP53 status is unknown.My sarcoma is TP53 wild type and MDM2-amplified, and it has spread.My cancer is confirmed and has spread from where it started.My cancer has grown or returned after treatment.I have symptoms from cancer spread not in my brain.I need to keep taking certain medications that may affect the trial's safety.
- Group 1: Dose Escalation
- Group 2: Dose Expansion
Frequently Asked Questions
Has BI 907828 received ratification from the FDA?
"Due to the limited data available on BI 907828, our team at Power has assigned it a score of 1 out of 3 in regards to safety as this is an early phase trial."
How many health care facilities are conducting this experiment?
"Participants in this medical study will be seen at Memorial Sloan-Kettering Cancer Center, The Ottawa Hospital and Yale University School of Medicine. Additionally, 6 other clinical trial sites are operational for the duration of this research project."
How many individuals are being recruited for participation in this experiment?
"This medical trial is looking for a total of 204 participants that meet the pre-determined criteria. It will be administrated by Boehringer Ingelheim from multiple sites, such as Memorial Sloan-Kettering Cancer Center in New york and The Ottawa Hospital in Ontario."
Are researchers still accepting participants for this research endeavor?
"Affirmative. Clinicaltrials.gov records show that this clinical trial, which initially opened on May 21st 2018, is actively accepting participants. 204 patients need to be enlisted from 6 different medical sites."
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