RECRUITING

Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer

Conditions

Small-cell Lung Cancer Small Cell Lung Carcinoma Lung Cancer Onvansertib Polo-like Kinase PLK1 Salvage Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2 Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer

Quick Facts

Study Start:2022-07-19

Study Completion:2027-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05450965

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Amelia Barkman, MHA

CONTACT

410-328-5009

amelia.barkman@umm.edu

Maha Khalil

CONTACT

410-328-5009

Mkhalil@umm.edu

Principal Investigator

Taofeek Owonikoko, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Study Locations (Sites)

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Collaborators and Investigators

Sponsor: Taofeek Owonikoko

Taofeek Owonikoko, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-19

Study Completion Date2027-11-30

Study Record Updates

Study Start Date2022-07-19

Study Completion Date2027-11-30

Terms related to this study

Keywords Provided by Researchers

Lung Cancer
Onvansertib
Polo-like Kinase
PLK1
Salvage Therapy

Additional Relevant MeSH Terms

Small-cell Lung Cancer
Small Cell Lung Carcinoma