Study of Onvansertib for Treating Relapsed Small Cell Lung Cancer

Sponsor: Taofeek Owonikoko

Sponsor score: 0

ClinicalTrials ID:NCT05450965

Provider View

This clinical trial is testing a new drug called onvansertib to see if it is safe and effective for patients with small cell lung cancer (SCLC) that has returned or is not responding to chemotherapy. Onvansertib works by blocking an enzyme that helps cancer cells repair themselves.

Patient Parameters

Program Overview

This study is looking at how well a new drug, onvansertib, works for patients with small cell lung cancer (SCLC) that has come back or isn't responding to treatment. Onvansertib targets an enzyme called PLK-1, which is often found in high levels in cancer cells and helps them repair. The trial will involve two stages, starting with 15 patients to see if the drug is effective. If successful, more patients will be enrolled based on specific genetic markers. The study will also determine the safest dose of onvansertib by closely monitoring the first few patients.

Description

This clinical trial is testing a new treatment called onvansertib for patients with small cell lung cancer (SCLC) that has returned or isn't responding to previous treatments. The study will be conducted in two stages. In the first stage, 15 patients will receive onvansertib to see if it helps reduce their cancer. If at least two patients show improvement, the study will move to the second stage, where more patients will be enrolled based on specific genetic markers.

The trial will start by giving onvansertib to the first six patients at a dose of 15 mg/m2 for 14 days in a 21-day cycle. These patients will be closely monitored to ensure the treatment is safe. If any serious side effects occur, the dose may be adjusted, and the safety process will be repeated. The study aims to find the safest dose of onvansertib and see if it can help control SCLC in patients who have not had success with other treatments.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of small cell lung cancer (SCLC).
  • Must have at least one tumor that can be measured by scans.
  • Must have tried standard chemotherapy treatments and either not responded or been unable to tolerate them.
  • Must be an adult aged 18 or older.
  • Must be able to take oral medication.
  • Must be in relatively good health, with an ECOG performance status of 0 to 2.
  • Must have normal organ and bone marrow function.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • Must agree to use effective birth control during the study.
  • Must be able to understand and sign a consent form.
  • Open to all genders and ethnic groups.

Exclusion Criteria

  • Have received chemotherapy or other cancer treatments recently (within the last 4 to 6 weeks).
  • Are currently participating in another clinical trial.
  • Have uncontrolled brain metastases or need high doses of steroids.
  • Have digestive issues that affect medication absorption.
  • Have allergies to similar drugs as onvansertib.
  • Have serious health conditions like heart problems or infections.
  • Have untreated or active hepatitis B, C, or HIV, unless stable on treatment.
  • Need ongoing treatment with certain growth factors.
  • Have had major surgery recently (within the last 2 weeks).
  • Are unable or unwilling to follow the study procedures.

Locations

FACILITYZIPCITYSTATE
University of Maryland Greenebaum Comprehensive Cancer Center21201BaltimoreMaryland
UPMC Hillman Cancer Center15232PittsburghPennsylvania

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