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New treatment option for Small-cell Lung Cancer
Official title Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05450965
What this study is testing
What is Onvansertib?
Onvansertib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for small-cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically or cytologically confirmed small cell lung cancer
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to...
- Patient must have failed or found to be intolerant of standard frontline platinum-based regimens and not more than two lines of cytotoxic...
- 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...
- Ability to tolerate oral medicine
You likely can't join if
- Treatment with chemotherapy (within 4 weeks; 6 weeks for nitrosoureas or mitomycin C); radiotherapy or biologic agents (within 2 weeks) prior to...
- Patients may not be receiving any other investigational agents (Use of conventional external beam radiation therapy will be allowed during protocol...
- Patients with uncontrolled symptomatic brain metastases. people with a history of central nervous system (CNS) metastases must have documentation of...
- Patients with active GI disorders likely to impair the absorption of oral medications
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to onvansertib.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
See the full eligibility criteria
- Patients must have histologically or cytologically confirmed small cell lung cancer
- 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...
- 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...
- 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...
- Ability to tolerate oral medicine
- ECOG performance status ≤2
- Patients must have normal organ and marrow function as pre-defined
- Negative serum pregnancy test within 48 hours before starting study treatment in women with childbearing potential
- Women of child-bearing potential and men must agree to use adequate contraception.
- Ability to understand and the willingness to sign a written informed consent document.
- Both men and women and members of all races and ethnic groups are eligible for this trial.
- 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...
- 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...
- Patients with uncontrolled symptomatic brain metastases. people with a history of central nervous system (CNS) metastases must have documentation of stable brain imaging after completion of definitive treatment and...
- Patients with active GI disorders likely to impair the absorption of oral medications
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to onvansertib.
- 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...
- 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...
- 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.
- Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- Patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.