Abemaciclib for Bladder Cancer
(CLONEVO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Single-arm, open-label window-of-opportunity trial of neoadjuvant Abemaciclib in 20 patients, with tumor tissue obtained as standard of care at tumor resection (pre-Abemaciclib) and cystectomy (post-Abemaciclib)
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot take strong CYP3A inhibitors within 7 days before starting the study drug, and you should not require continuous treatment with them during the trial.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot take strong CYP3A inhibitors within 7 days before starting the study drug. It's best to discuss your current medications with the trial team.
What safety data exists for Abemaciclib in bladder cancer treatment?
The provided research does not contain specific safety data for Abemaciclib (also known as Verzenio, LY2835219, Ramiven) in the treatment of bladder cancer. The studies focus on other treatments such as gemcitabine, cisplatin, lapatinib, dovitinib, and various immunotherapies for bladder cancer. Therefore, no safety data for Abemaciclib in this context is available from the given research.12345
Is Abemaciclib a promising drug for bladder cancer?
How is the drug Abemaciclib unique for treating bladder cancer?
Abemaciclib is unique for treating bladder cancer because it is a targeted therapy that works by inhibiting specific proteins (CDK4 and CDK6) involved in cell division, which is different from traditional chemotherapy that targets all rapidly dividing cells. This approach may offer a more personalized treatment option compared to the standard chemotherapy regimens like cisplatin and gemcitabine.45679
What data supports the idea that Abemaciclib for Bladder Cancer is an effective drug?
The available research does not provide specific data supporting the effectiveness of Abemaciclib for treating bladder cancer. Instead, it discusses other treatments like chemotherapy and targeted therapies for bladder cancer. For example, cisplatin and gemcitabine are commonly used, and new therapies are being developed to target specific genetic changes in bladder cancer. While Abemaciclib is used for other conditions, there is no direct evidence here showing its effectiveness for bladder cancer.26101112
Who Is on the Research Team?
Bishoy Faltas, MD
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with muscle-invasive bladder cancer (MIBC) stages T2-T4, who can't or won't use cisplatin-based chemo. They must be fit for surgery, not have had recent major surgery or anti-cancer therapy, and agree to contraception if applicable.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Abemaciclib at 200 mg every 12 hours for at least 4 weeks
Surgery
Radical cystectomy is performed after the treatment phase
Follow-up
Participants are monitored for survival endpoints and adverse events for 3 years after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Abemaciclib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University