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Bladder CancerEarly Phase 1CLONEVONCT03837821

(CLONEVO): Cell cycLe inhbitiON to Target the EVolution of UrOthelial Cancer

A Early Phase 1 study testing Abemaciclib in people with Bladder Cancer, run by Weill Medical College of Cornell University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Abemaciclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
5 Feb 2019to May 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old at time of informed consent
  • Histologically confirmed MIBC (T2-T4) pure or mixed histology urothelial carcinoma [urothelial carcinoma should be the dominant (>50%) histology].
  • Refusing cisplatin-based chemotherapy or ineligible for cisplatin-based chemotherapy due to at least one of the following:
  • Creatinine clearance < 60 mL/min (by Cockcroft-Gault calculation and/or measured creatinine clearance)
  • Hearing loss ≥ grade 2 by CTCAE criteria and/or;
  • Neuropathy ≥ grade 2 by CTCAE criteria and/or
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  • Heart failure NYHA ≥ III
  • Medically fit for TURBT and radical cystectomy
  • Adequate organ and marrow function as defined below:
  • Absolute neutrophil count ≥ 1.5 K/mm3
  • White blood cell count (WBC) > 3.0 K/mm3
  • Platelets ≥ 100 K/mm3
  • Hemoglobin ≥ 9 g/dL
  • Serum total bilirubin ≤ 1.5 x ULN (Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted)
  • ALT and AST ≤ 3.0 x ULN
  • Ability to swallow oral medications
  • Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization

Who cannot join

  • Patients with locally advanced unresectable or metastatic urothelial carcinoma as assessed on baseline radiographic imaging obtained within from the date of signed consent, 28 days prior to study enrollment. Low volume (<1.5 cm) suspicious lymph node metastases in the pelvis are allowed if they are in the LN dissection template field. The required radiographic imaging includes:
  • Abdomen/pelvis - CT/MRI
  • Chest - chest x-ray or CT scan
  • Bone scan or FDG-PET/CT in the presence of bone pain or unexplained elevated alkaline phosphatase
  • Patients with another active second malignancy other than non-melanoma skin cancers and localized prostate cancer. Patients that have completed all necessary therapy and are considered to be <30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment.
  • Patients who have received anti-cancer therapy including chemotherapy, radiotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks or 5 half-lives, whichever is longer, prior to starting study drug. Patients who received chemotherapy must have recovered to CTCAE Grade ≤1 from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to Cycle 1 Day 1. Patients currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study are also excluded.
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  • Patients who have serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
  • Patients who have had major surgery within 14 days prior to Cycle 1 Day 1.
  • Have an active bacterial infection (especially if requiring IV antibiotics), systemic fungal and/or known viral infection (for example, human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies).
  • Subjects who received a strong CYP3A inhibitor within 7 days prior to the first dose of study drug, or patients who require continuous treatment with a strong CYP3A inhibitor
  • The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
  • Pregnant or breast-feeding women
  • Women who do not agree to use a medically approved contraceptive method during the treatment period and for 3 weeks following the last dose of Abemaciclib
  • Men who do not agree to use a reliable method of birth control and to not donate sperm during the study and for at least 3 months following the last dose of Abemaciclib
  • Subjects unwilling or unable to comply with the protocol

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UT Southwestern Medical Center - Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390

  • Weill Cornell Medicine

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Window-of-opportunity Trial of Abemaciclib Followed by Radical Cystectomy in Patients With Platinum-ineligible Urothelial Carcinoma to Evaluate CDK4/6-dependent Phosphorylation of Pocket Proteins and Clonal Evolution Dynamics

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)

Read the detailed description

A Window-of-Opportunity Trial of Abemaciclib followed by radical cystectomy in patients with Platinum-Ineligible Urothelial Carcinoma to Evaluate CDK4/6-Dependent Phosphorylation of Pocket Proteins and Clonal Evolution Dynamics. Subjects will be treated with Abemaciclib at 200 mg every 12 hours for at least 4 weeks (and likely slightly longer depending upon surgical date). Individual dose reductions will be made on the basis of the AEs observed. In the absence of treatment delays due to adverse event(s), treatment will be continued until the surgical date unless any of the following criteria applies: 1-Disease progression; 2-Intercurrent illness that prevents further administration of treatment; 3-Unacceptable adverse event(s) as a result of Abemaciclib; 4- Patient decides to withdraw from the study; 5-General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator. Patients will be followed with history, physical, and blood tests at each visit to monitor for toxicity. Patients will be followed for survival endpoints following completion of this study for 3 years after surgery or until death. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.

Conditions
Bladder Cancer
Being tested
Abemaciclib
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03837821
Study groupRoleWhat they receive
All SubjectsExperimentalAbemaciclib 200 mg oral, every 12 hours
Receives: Drug: Abemaciclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cell-cycle dynamics between pre- and post-Abemaciclib tumor samples

    Cell-cycle dynamics will be assessed by immunohistochemistry of tumor tissues, circulating tumor DNA (ctDNA) blood samples.

    Measured: At baseline and post 4 week treatment

Secondary outcomes (2)

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs) of Abemaciclib

    TEAEs will be assessed by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Measured: At baseline through 3 year follow up

  2. Effect on tumor downstaging defined as <pT2 at time of cystectomy

    Tumor downstaging will be assess from tissue collected at the time of cystectomy.

    Measured: At baseline and post 4 week treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2019
  2. Study start5 Feb 2019
  3. Primary completion2 Jul 2024
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03837821
Sponsor's protocol ID
1710018693
Acronym
CLONEVO
Status last verified
Oct 2026
First submitted
6 Feb 2019
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Abemaciclib in people with Bladder Cancer, run by Weill Medical College of Cornell University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cell-cycle dynamics between pre- and post-Abemaciclib tumor samples (time frame: At baseline and post 4 week treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03837821.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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