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Abemaciclib for Bladder Cancer (CLONEVO Trial)

Phase < 1
Recruiting
Led By Bishoy Faltas, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old at time of informed consent
Adequate organ and marrow function including specified blood counts, bilirubin levels, liver enzymes, and ability to swallow oral medications
Must not have
Women and men who do not agree to use medically approved contraceptive methods
Use of strong CYP3A inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline through 3 year follow up
Awards & highlights

Summary

This trial looks at whether the drug Abemaciclib can shrink tumors before surgery. Tissue from the tumors will be collected before and after patients take the drug to see if there is a difference.

Who is the study for?
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.Check my eligibility
What is being tested?
The trial tests Abemaciclib as a neoadjuvant treatment in bladder cancer patients. It's a single-arm study where all participants receive the drug before their tumors are surgically removed, allowing comparison of tissue samples before and after treatment.See study design
What are the potential side effects?
Abemaciclib may cause side effects like diarrhea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver issues indicated by abnormal blood tests, and potential harm to an unborn baby.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My blood tests, liver function, and ability to take pills are all within normal ranges.
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I finished radiotherapy at least 14 days ago and have recovered from its immediate effects.
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My bladder cancer is mostly urothelial and confirmed by tissue analysis.
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I cannot or choose not to undergo chemotherapy with cisplatin.
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I am medically cleared for bladder tumor surgery and bladder removal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I agree to use birth control as advised by my doctor.
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I am taking medication that strongly affects liver enzyme activity.
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I have not had major surgery in the last 14 days.
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I do not have any ongoing infections.
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My cancer is advanced and cannot be removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline through 3 year follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline through 3 year follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in cell-cycle dynamics between pre- and post-Abemaciclib tumor samples
Secondary outcome measures
Effect on tumor downstaging defined as <pT2 at time of cystectomy
Incidence of Treatment-Emergent Adverse Events (TEAEs) of Abemaciclib
Other outcome measures
Impact of Abemaciclib on clonal evolution

Side effects data

From 2018 Phase 2 trial • 132 Patients • NCT02102490
91%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
White blood cell count decreased
18%
Neutropenia
15%
Alopecia
14%
Platelet count decreased
14%
Dry mouth
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Pyrexia
11%
Dyspepsia
11%
Oedema peripheral
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Flatulence
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Gastrooesophageal reflux disease
5%
Rash
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Gastroenteritis viral
1%
Atypical pneumonia
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib

Trial Design

1Treatment groups
Experimental Treatment
Group I: All SubjectsExperimental Treatment1 Intervention
Abemaciclib 200 mg oral, every 12 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,064 Previous Clinical Trials
1,319,166 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,629 Previous Clinical Trials
3,218,090 Total Patients Enrolled
Bishoy Faltas, MDPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Abemaciclib Clinical Trial Eligibility Overview. Trial Name: NCT03837821 — Phase < 1
Bladder Cancer Research Study Groups: All Subjects
Bladder Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT03837821 — Phase < 1
Abemaciclib 2023 Treatment Timeline for Medical Study. Trial Name: NCT03837821 — Phase < 1
~1 spots leftby Dec 2024
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