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PLK1 Inhibitor
Onvansertib for Chronic Myelomonocytic Leukemia
Phase 1
Recruiting
Led By Mrinal S Patnaik
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is testing a new drug, onvansertib, to see if it is safe and effective in treating patients with a certain type of leukemia. Onvansertib works by inhibiting an enzyme called PLK1, which prevents cancer cell proliferation and causes cell death.
Who is the study for?
Adults with chronic myelomonocytic leukemia that's returned or isn't responding to treatment, who've had specific prior treatments and have a certain level of health (good organ function, no severe concurrent illnesses). They must be able to consent, complete questionnaires, provide samples for research, and agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing Onvansertib's safety and optimal dose. It involves collecting biological specimens and performing bone marrow biopsies plus ultrasound imaging. Onvansertib targets an enzyme in cancer cells to stop their growth and cause cell death.See study design
What are the potential side effects?
While the side effects are not explicitly listed here, drugs like Onvansertib typically may cause fatigue, nausea, diarrhea, low blood counts leading to increased infection risk or bleeding problems. Organ-specific inflammation could also occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Complete response (CR) rate
Constitutional symptoms
Overall remission rate (ORR)
+1 moreSide effects data
From 2021 Phase 1 & 2 trial • 72 Patients • NCT0330333938%
Febrile neutropenia
31%
Hypokalaemia
28%
Diarrhoea
28%
Stomatitis
25%
Fatigue
22%
Nausea
22%
Epistaxis
19%
Oedema peripheral
19%
Platelet count decreased
19%
Alopecia
16%
Hypophosphataemia
16%
Acute myeloid leukaemia
16%
Sepsis
16%
Dyspnoea
16%
Cough
16%
Hypoalbuminaemia
13%
Hypoxia
13%
Lung infection
13%
Anaemia
13%
Rash maculo-papular
13%
Rash
13%
Hypocalcaemia
13%
Arthralgia
13%
Hypertension
13%
Hypotension
9%
Electrocardiogram QT prolonged
9%
Syncope
9%
Pneumonia
9%
Cellulitis
9%
Headache
9%
Abdominal pain upper
9%
Oral pain
9%
Staphylococcal infection
9%
Urinary tract infection
9%
Hypomagnesaemia
9%
Dizziness
9%
Oropharyngeal pain
9%
Petechiae
9%
Decreased appetite
9%
Alanine aminotransferase increased
9%
Abdominal pain
9%
Escherichia bacteraemia
9%
Blood creatine increased
9%
Mucosal inflammation
9%
Hyperbilirubinaemia
9%
Pleural effusion
9%
Vomiting
6%
Dry mouth
6%
Ear pain
6%
Lower gastrointestinal haemorrhage
6%
Fluid overload
6%
Dry skin
6%
Oral candidiasis
6%
Neuropathy peripheral
6%
Fall
6%
Pyrexia
6%
Nasal congestion
6%
Ecchymosis
6%
Blood alkaline phosphatase
6%
Insomnia
6%
Pain in extremity
6%
Haematemesis
6%
Odynophagia
6%
Proctalgia
6%
Staphylococcal bacteraemia
6%
Bacteraemia
6%
Pneumonia fungal
6%
Pruritus
6%
Dermatitis contact
6%
Purpora
6%
Non-cardiac chest pain
6%
Hyperkalaemia
6%
Hypercalcaemia
6%
Flank pain
6%
Aspartate aminotransferase increased
6%
Neutrophil count decreased
6%
Blood bilirubin increased
6%
Pleuritic pain
6%
Haematoma
6%
Conjunctival haemorrhage
3%
Hyperglycaemia
3%
Atrial fibrillation
3%
Myalgia
3%
Back pain
3%
Tumour lysis syndrome
3%
Mallory-Weiss syndrome
3%
Upper gastrointestinal haemorrhage
3%
Pain
3%
Respiratory failure
3%
Rash pruritic
3%
Musculoskeletal pain
3%
Face oedema
3%
Hyponatraemia
3%
Contusion
3%
Septic shock
3%
Candida infection
3%
Granulicatella bacteraemia
3%
Kidney infection
3%
Pancytopenia
3%
Colitis
3%
Melaena
3%
Constipation
3%
Transfusion reaction
3%
Dysgeusia
3%
Dyspnoea exertional
3%
Wheezing
3%
Neutropenia
3%
Weight decreased
3%
Anxiety
3%
Eye pruritus
3%
White blood cell count decreased
3%
Neutropenic colitis
3%
Mental status changes
3%
Chills
3%
Sinus tachycardia
3%
Haemoptysis
3%
Aphasia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: Onvansertib 60 mg/m^2 + Decitabine
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (onvansertib)Experimental Treatment4 Interventions
Patients receive onvansertib PO QD on study. Patients also undergo bone marrow aspiration and biopsy, collection of blood samples, and ultrasound imaging during screening and throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound Imaging
2018
Completed Phase 4
~730
Biospecimen Collection
2004
Completed Phase 2
~1730
Onvansertib
2017
Completed Phase 2
~220
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,210 Previous Clinical Trials
3,767,229 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,980 Total Patients Enrolled
Mrinal S PatnaikPrincipal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a type of blood disorder that is not CMML.I have been treated with a PLK1 inhibitor before.My kidney function, measured by eGFR, is good.I have not had major surgery in the last 6 weeks.I have no active cancer except for nonmelanoma skin cancer or cancers treated over 2 years ago with no current signs of disease.I cannot or do not want to take pills.I need treatment that suppresses my immune system, not including inhaled or topical steroids.My condition worsened after treatment with hydroxyurea or I can't tolerate it.I have recovered from side effects of past treatments, except for hair loss.I do not have severe GI issues that would affect medication absorption.I am 18 years old or older.I am not on any experimental drugs for my cancer.I am not taking any strong medications that affect liver enzymes.My blood test shows a high white cell count, indicating CMML.I have had a stem cell transplant from a donor.I have an active brain or spinal cord condition.My leukemia diagnosis is confirmed and my white blood cell count is high.My heart's electrical activity (QTcF) is over 470 milliseconds.I am able to care for myself and perform daily activities.I do not have any health conditions that would make the study treatment unsafe for me.I have severe heart issues or chest pain.I haven't had cancer treatment in the last 2 weeks, except for hydroxyurea.I agree to use effective birth control or avoid pregnancy during and for 6 months after the study.I do not have any severe illnesses or conditions that my doctor is still trying to get under control.I have an active HIV, hepatitis B, or hepatitis C infection with measurable virus levels.I haven't received a live vaccine within the last 28 days, except for COVID-19 vaccines like Pfizer or Moderna.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (onvansertib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What does the evidence show about Onvansertib's safety profile?
"Onvansertib is classified as a phase 1 drug, meaning that there is only preliminary evidence suggesting that it is safe and effective."
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