Actively Recruiting
Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer
Led by University of Maryland, Baltimore · Updated on 2025-12-17
37
Participants Needed
2
Research Sites
280 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
C
Cardiff Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II clinical trial will study the safety and efficacy of onvansertib to treat patients with small cell lung cancer (SCLC) who have either not responded to or are unable to tolerate chemotherapy. Onvansertib is a drug that inhibits polo-like kinase 1 (PLK-1), an enzyme that is over-expressed in many cancer cells and is involved in cellular repair.
CONDITIONS
Official Title
Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis confirmed by tissue or cell analysis as small cell lung cancer
- Measurable disease with at least one lesion larger than 20 mm by conventional methods or 10 mm by spiral CT scan
- Have failed or cannot tolerate standard frontline platinum-based chemotherapy and have received no more than two total lines of cytotoxic chemotherapy for extensive disease
- Adults aged over 18 years
- Able to take oral medication
- ECOG performance status of 0, 1, or 2
- Normal organ and marrow function as defined by the study
- Negative pregnancy test within 48 hours before starting treatment for women who can become pregnant
- Women of childbearing potential and men agree to use effective contraception
- Able to understand and willing to sign informed consent
- Open to all genders, races, and ethnic groups
You will not qualify if you...
- Received chemotherapy within 4 weeks (6 weeks for certain drugs), radiotherapy or biologic agents within 2 weeks before first dose of onvansertib
- Currently receiving other investigational agents (except limited radiation for symptom relief)
- Uncontrolled symptomatic brain metastases or unstable brain imaging
- Active gastrointestinal disorders affecting oral drug absorption
- History of allergic reaction to onvansertib or similar compounds
- Uncontrolled illnesses such as infections, heart failure, unstable angina, arrhythmias, or psychiatric/social conditions limiting study compliance
- Untreated or active hepatitis B, hepatitis C, or HIV infection (stable HIV with undetectable viral load allowed with approval)
- Require ongoing treatment with certain blood growth factors within 2 weeks before starting study drug
- Major surgery within 2 weeks before starting study drug or not recovered from surgery side effects
- Unable or unwilling to follow study protocol or cooperate fully with investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
2
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Active, Not Recruiting
Research Team
A
Amelia Barkman, MHA
CONTACT
M
Maha Khalil
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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