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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~up to 3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3.5 years for reporting.

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 • NCT03303339
38%
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%
Ear pain
6%
Lower gastrointestinal haemorrhage
6%
Dry mouth
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%
Mallory-Weiss syndrome
3%
Hyperglycaemia
3%
Myalgia
3%
Back pain
3%
Atrial fibrillation
3%
Tumour lysis 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, radiotherapy, and immunotherapy. Chemotherapy, often using drugs like etoposide and cisplatin, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Radiotherapy uses high-energy radiation to kill cancer cells and shrink tumors. Immunotherapy, such as anti-PD-1 or anti-PD-L1 therapies, enhances the body's immune response against cancer cells. These treatments are crucial for SCLC patients due to the aggressive nature of the disease and its tendency to spread quickly. Additionally, PLK-1 inhibitors like Onvansertib target the polo-like kinase 1 enzyme, which is involved in cell division and is overexpressed in many cancers, including SCLC. By inhibiting PLK-1, these drugs can disrupt cancer cell proliferation and induce apoptosis, offering a potential new avenue for treatment.
Caspase-9b Interacts Directly with cIAP1 to Drive Agonist-Independent Activation of NF-κB and Lung Tumorigenesis.Overcoming resistance to tyrosine kinase inhibitors in renal cell carcinoma.Frequent overexpression of the c-kit protein in large cell neuroendocrine carcinoma of the lung.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,726 Previous Clinical Trials
7,495,872 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

Onvansertib (PLK-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05450965 — Phase 2
Small Cell Lung Cancer Research Study Groups: Single Treatment Arm
Small Cell Lung Cancer Clinical Trial 2023: Onvansertib Highlights & Side Effects. Trial Name: NCT05450965 — Phase 2
Onvansertib (PLK-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05450965 — Phase 2
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