Phase 2 Study of Onvansertib for Relapsed Small Cell Lung Cancer
This study is testing a drug called onvansertib for people with small cell lung cancer (SCLC) that has come back or didn't respond to chemotherapy. Onvansertib works by blocking an enzyme (a type of protein) called PLK-1, which is often found in high levels in cancer cells. The study aims to see how well onvansertib shrinks tumors (Objective Response Rate) over a period of up to 42 months. You might be able to join if you are 18 or older, have SCLC that can be measured, and have received no more than two previous treatments. The study plans to enroll 37 participants, but the current recruitment status is unclear.
- Study design
- This is a single-arm, two-stage Phase 2 study. It will enroll up to 37 participants to test onvansertib.
- What's involved
- You would take onvansertib orally for 14 days, followed by 7 days off, in 21-day cycles. Treatment continues until your disease gets worse or side effects become too much.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how well the treatment works for up to 42 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Taofeek Owonikoko, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore
Who to contact
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What this trial measures
- Objective Response Rate (ORR)Up to 42 months (cohort)
The proportion of patients having either a complete response (CR) or partial response (PR) (as best response), per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. For non-target lesions, CR is the disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.