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(CLONEVO): Cell cycLe inhbitiON to target the EVolution of urOthelial cancer

Clinical Trial Details

This is a clinical trial for men and women age 18 and older diagnosed with advanced bladder cancer who are not eligible or choose not to receive chemotherapy before standard-of-care surgery for bladder cancer

The purpose of this study is to test the safety of the study drug, abemaciclib, and see what effects (good and bad) it has in muscle-invasive bladder cancer. 

Abemaciclib is an active compound in other cancers. It has been approved by the FDA in combination with fulvestrant to treat women with hormone receptor (HR)–positive breast cancer, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer or metastatic breast cancer whose disease has progressed after hormonal therapy. It has also been approved alone to treat adults with HR–positive, HER2–negative advanced breast cancer or metastatic breast cancer whose disease has progressed after hormonal therapy and prior chemotherapy.

Over half of bladder cancer patients have changes in specific genes that control how cancer cells divide (cell-cycle genes). This alteration may render cancer cells sensitive to the effects of abemaciclib, which slows down or inhibits the division of cancer cells.

The total duration of the study participation is approximately 3 years. The treatment phase is made up of 6 visits and will last a maximum of 8 weeks. Abemaciclib is taken by mouth every 12 hours.

After completion of the treatment,  participants will be required to visits clinic every few months for follow-up visits.

Key Eligibility: 
  • Adults diagnosed with advanced bladder cancer
  • Scheduled to have standard-of-care surgery for advanced bladder cancer

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amie Patel, RN
212-746-1480
amp3002@med.cornell.edu

Angela Tan, RN
212-746-4154
ant4009@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1710018693

Status

Open to Enrollment

Age Group

Adult

Sponsor