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PLK-1 Inhibitor
Onvansertib for Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Taofeek Owonikoko, MD, PhD
Research Sponsored by Taofeek Owonikoko
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients with age >18 years. Because no dosing or adverse event data are currently available on the use of arsenic trioxide in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3.5 years
Awards & highlights
Study Summary
This trial will study whether onvansertib is safe and effective at treating small cell lung cancer in patients who can't tolerate or haven't responded to chemotherapy.
Who is the study for?
This trial is for adults over 18 with small cell lung cancer (SCLC) who have tried and not responded to or can't tolerate chemotherapy. They must be able to take oral medication, use contraception, and have a certain level of physical fitness (ECOG ≤2). People with more than two prior chemo treatments, active hepatitis B/C or HIV without approval, recent major surgery, ongoing serious illnesses, or untreated brain metastases cannot join.Check my eligibility
What is being tested?
The trial is testing Onvansertib's safety and effectiveness in treating SCLC. Onvansertib blocks PLK-1 enzymes that help cancer cells repair themselves. Participants will receive this drug after failing standard platinum-based therapies and up to two lines of cytotoxic chemotherapy for extensive stage disease.See study design
What are the potential side effects?
Potential side effects include allergic reactions similar to those from drugs like Onvansertib; however specific side effects are not listed as data on adverse events are currently unavailable. Patients' normal organ function must be confirmed before starting treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
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I have a tumor that can be measured with a scan.
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My lung cancer diagnosis was confirmed through lab tests.
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I can take care of myself but might not be able to do heavy physical work.
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My organ and bone marrow functions are normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Overall survival (OS)
Progression-free survival (PFS)
Side 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: Single Treatment ArmExperimental Treatment1 Intervention
Onvansertib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Onvansertib
Not yet FDA approved
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,502 Total Patients Enrolled
Taofeek OwonikokoLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
Cardiff OncologyIndustry Sponsor
10 Previous Clinical Trials
582 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy, radiotherapy, or biologic agents recently.I've had 1 or 2 chemotherapy treatments for advanced lung cancer and can't tolerate standard treatments.I had major surgery less than 2 weeks ago or am still dealing with its side effects.I am willing and able to follow the study rules and work with the research team.I have a tumor that can be measured with a scan.I haven't used blood cell growth factors within 2 weeks before starting the study drug.I am over 18 years old.I have a stomach or intestine problem that affects how I absorb pills.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am not on any experimental drugs but may receive radiation for pain or to prevent bone fractures.My brain metastases are stable, and I'm on a low or no dose of steroids.I do not have active hepatitis B, C, or HIV, or I am on stable HIV treatment with an undetectable viral load.My lung cancer diagnosis was confirmed through lab tests.I can take care of myself but might not be able to do heavy physical work.I agree to use birth control during the study.I can take medicine by mouth.I am eligible for this trial regardless of my gender, race, or ethnicity.Women who can have children need to have a negative pregnancy test within 48 hours before starting the study treatment.My organ and bone marrow functions are normal.
Research Study Groups:
This trial has the following groups:- Group 1: Single Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we currently looking for more participants for this clinical trial?
"The trial, which was originally posted on 7/19/2022 and updated last on 7/29/2022, is presently recruiting patients as reported by clinicaltrials.gov"
Answered by AI
How many volunteers are currently enrolled in this experiment?
"Indeed, the trial is presently recruiting patients as indicated by information on clinicaltrials.gov. The original posting was on 7/19/2022 and there have been 37 edits as of 7/29/2022. Currently, 1 sites are looking for participants."
Answered by AI
What are the potential Onvansertib side effects that patients should be aware of?
"Onvansertib's safety is supported by some data, but since this is only a Phase 2 trial, there is no evidence yet of its efficacy. Therefore, it received a score of 2."
Answered by AI
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