A Phase 2 Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer
University of Maryland, Baltimore
Summary
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.
Description
This is a single arm, two stage, phase II study of onvansertib in patients with relapsed SCLC who have received not more than 2 lines of prior therapies. The study will enroll 15 patients in stage I. Enrolment into stage II will occur if two or more patients achieve objective response. Subsequent enrolment into stage II will be by biomarker selection if the stage I accrual supports any of the three preliminarily nominated biomarkers i.e., TP53 mutation type, SCLC-Y or MYC expression. In order to establish the safety and tolerability of onvansertib at the dose of 15 mg/m2 on D1-D14 of a 21-day…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 c…
Interventions
- DrugOnvansertib
Onvansertib at a dose of 15 mg/m2 orally on Days 1-14 of a 21-day cycle. Treatment will continue until disease progression or intolerable toxicity.
Locations (2)
- University of Maryland Greenebaum Comprehensive Cancer CenterBaltimore, Maryland
- UPMC Hillman Cancer CenterPittsburgh, Pennsylvania