Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer
A Phase 2 Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe onvansertib is and how well it works for small cell lung cancer. It is for adults whose cancer did not respond to chemotherapy or who could not tolerate it. The drug blocks PLK1, a protein involved in cell repair that is found at high levels in many cancer cells.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be older than 18, with small cell lung cancer confirmed by a tissue or cell test.
- Have at least one cancer spot large enough to measure under the study rules.
- Have tried standard platinum-based chemotherapy that did not work or could not be tolerated. Have had no more than two courses of chemotherapy for widespread disease; special counting rules apply to earlier treatment.
- Be able to take medicine by mouth.
- Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
- Have organ and bone marrow function that meets the study's test limits.
- If able to become pregnant, have a negative blood pregnancy test within 48 hours before treatment. Women who can become pregnant and men must agree to use birth control.
- Be able to understand the study and agree in writing to take part.
Who can't join
- Have had chemotherapy within 4 weeks (6 weeks for certain drugs), or radiation or biologic cancer treatment within 2 weeks. Lasting, significant side effects from earlier treatment may also keep you out.
- Be taking another experimental drug.
- Have uncontrolled brain cancer spread that causes symptoms. Previously treated brain spread must be stable on scans, with no steroid use or a stable dose no higher than 10 mg of prednisone or its equivalent.
- Have an active stomach or bowel problem that could keep your body from absorbing pills, or a past allergic reaction to a drug similar to onvansertib.
- Have an uncontrolled illness, such as an infection or serious heart problem, or mental health or social problems that prevent following study rules. Be unable or unwilling to follow those rules.
- Have untreated or active hepatitis B, hepatitis C, or HIV. An exception needs sponsor approval, at least 6 months on stable antiviral treatment, and virus levels too low to detect.
- Need ongoing medicines that help your body make blood cells within 2 weeks before starting the study drug.
- Have had major surgery within 2 weeks before starting the study drug, or have not recovered from its side effects.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Patients must have histologically or cytologically confirmed small cell lung cancer 2. 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. See Section 8for the evaluation of measurable disease. 3. Patient must have failed or found to be intolerant of standard frontline platinum-based regimens and not more than two lines of cytotoxic chemotherapy treatment in total for extensive stage disease. Maintenance immunotherapy counts as part of the frontline therapy, while prior chemotherapy for limited stage disease will not count toward this total if completed more than 12 months before initiation of protocol therapy. Retreatment with the original chemotherapy regimen for sensitive relapsed SCLC counts as a separate line of treatment. 4. 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. 5. Ability to tolerate oral medicine 6. ECOG performance status ≤2 7. Patients must have normal organ and marrow function as pre-defined 8. Negative serum pregnancy test within 48 hours before starting study treatment in women with childbearing potential 9. Women of child-bearing potential and men must agree to use adequate contraception. 10. Ability to understand and the willingness to sign a written informed consent document. 11. Both men and women and members of all races and ethnic groups are eligible for this trial. Exclusion Criteria: 1. Treatment with chemotherapy (within 4 weeks; 6 weeks for nitrosoureas or mitomycin C); radiotherapy or biologic agents (within 2 weeks) prior to first dose of onvansertib or those persistent, clinically significant, grade ≥2 adverse events due to agents administered more than 4 weeks earlier. 2. Patients may not be receiving any other investigational agents (Use of conventional external beam radiation therapy will be allowed during protocol therapy solely for palliation of localized painful lesions or bone lesions at risk of fracture provided the radiation field does not encompass any selected target lesions required for assessment). 3. Patients with uncontrolled symptomatic brain metastases. Subjects with a history of central nervous system (CNS) metastases must have documentation of stable brain imaging after completion of definitive treatment and prior to first dose of Study Drug. Patients must be off or on a stable dose of corticosteroids (not more than 10mg prednisone or equivalent). Definitive treatment may include surgical resection, whole brain irradiation, and/or stereotactic radiation therapy. 4. Patients with active GI disorders likely to impair the absorption of oral medications 5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to onvansertib. 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 7. Patient with untreated or active HBV, HCV and HIV are ineligible. Patients on stable doses of antiretroviral for at least six months and undetectable viral load will be enrolled with prior approval of the study sponsor. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. 8. Patients who require ongoing treatment with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug. 9. Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy 10. Patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator.
Study sites (2)
MD
- University of Maryland Greenebaum Comprehensive Cancer Center · Baltimore, MD 21201Taofeek Owonikoko, MD, PhD · Study contactTaofeek Owonikoko, MD, PhD · Principal investigatorMore trials in Baltimore
PA
- UPMC Hillman Cancer Center · Pittsburgh, PA 15232More trials in Pittsburgh