Condition or disease | Intervention/treatment | Phase |
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Locally Advanced Leiomyosarcoma Metastatic Leiomyosarcoma Stage III Retroperitoneal Sarcoma AJCC v8 Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 Stage IIIA Retroperitoneal Sarcoma AJCC v8 Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 Stage IIIB Retroperitoneal Sarcoma AJCC v8 Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 Stage IV Retroperitoneal Sarcoma AJCC v8 Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 Unresectable Leiomyosarcoma | Drug: Niraparib Tosylate Monohydrate | Phase 2 |
PRIMARY OBJECTIVES:
I. To evaluate whether niraparib tosylate monohydrate (niraparib) shows preliminary evidence of clinical activity among subjects with leiomyosarcoma (LMS) with genomic alterations in the homologous recombination (HR) pathway as measured by the confirmed objective response rate (ORR).
SECONDARY OBJECTIVES:
I. To evaluate the clinical benefit rate (CBR) associated with niraparib treatment in the study population.
II. To evaluate the progression free survival (PFS) associated with niraparib treatment in the study population.
III. To evaluate the overall survival (OS) associated with niraparib treatment in the study population.
IV. To evaluate the overall safety and tolerability of niraparib treatment in the study population.
EXPLORATORY OBJECTIVES:
I. To evaluate predictive biomarkers of response to niraparib. II. To evaluate genomic mechanisms of resistance following treatment benefit with niraparib.
III. To evaluate previous treatment response as a marker of response to niraparib.
OUTLINE:
Patients receive niraparib orally (PO) once daily (QD). Cycles repeat every 28 days for 15 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years or until death.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 22 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Niraparib for Leiomyosarcoma With Alterations in the Homologous Recombination DNA Repair Pathway |
Estimated Study Start Date : | January 1, 2022 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2025 |
Arm | Intervention/treatment |
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Experimental: Treatment (Niraparib)
Patients receive niraparib PO QD. Cycles repeat every 28 days for 15 months in the absence of disease progression or unacceptable toxicity.
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Drug: Niraparib Tosylate Monohydrate
Given PO
Other Name: Zejula
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have had a recent, within six months of screening, tumor biopsy testing positive for pathogenic mutation or homozygous loss of either BARD1, BRCA1, BRCA2, BRIP1, PALB2, RAD51, RAD51B, RAD51C, or RAD51D using a clinically validated next-generation (NGS) sequencing panel.
Female participant has either a negative highly sensitive urine or a serum pregnancy test within 72 hours prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of nonchildbearing potential. Nonchildbearing potential is defined as follows (by other than medical reasons):
Exclusion Criteria:
Participant has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of central nervous system (CNS) hemorrhage.
Contact: The Ohio State University Comprehensive Cancer Center | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
United States, Ohio | |
Ohio State University Comprehensive Cancer Center | |
Columbus, Ohio, United States, 43210 | |
Contact: James L. Chen, MD 614-688-7565 | |
Principal Investigator: James L. Chen, MD |
Principal Investigator: | James L Chen, MD | Ohio State University Comprehensive Cancer Center |
Tracking Information | |||||
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First Submitted Date ICMJE | December 13, 2021 | ||||
First Posted Date ICMJE | December 30, 2021 | ||||
Last Update Posted Date | December 30, 2021 | ||||
Estimated Study Start Date ICMJE | January 1, 2022 | ||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Confirmed objective response rate (ORR) [ Time Frame: Within first 6 months of study treatment ] Defined as complete response + partial response measured by Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1). Will be calculated as the proportion of patients who achieve a response (complete response + partial response) within the first 6 months of treatment divided by the total number of evaluable patients. An evaluable patient is defined as an eligible patient who has received at least one dose of therapy. All evaluable patients will be included in calculating the ORR for the study along with corresponding 95% binomial confidence intervals (CIs) (assuming that the number of patients who respond is binomially distributed).
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Niraparib for the Treatment of Leiomyosarcoma | ||||
Official Title ICMJE | Phase II Study of Niraparib for Leiomyosarcoma With Alterations in the Homologous Recombination DNA Repair Pathway | ||||
Brief Summary | This phase II trial tests whether niraparib works to shrink tumor in patients with leiomyosarcoma. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. | ||||
Detailed Description |
PRIMARY OBJECTIVES: I. To evaluate whether niraparib tosylate monohydrate (niraparib) shows preliminary evidence of clinical activity among subjects with leiomyosarcoma (LMS) with genomic alterations in the homologous recombination (HR) pathway as measured by the confirmed objective response rate (ORR). SECONDARY OBJECTIVES: I. To evaluate the clinical benefit rate (CBR) associated with niraparib treatment in the study population. II. To evaluate the progression free survival (PFS) associated with niraparib treatment in the study population. III. To evaluate the overall survival (OS) associated with niraparib treatment in the study population. IV. To evaluate the overall safety and tolerability of niraparib treatment in the study population. EXPLORATORY OBJECTIVES: I. To evaluate predictive biomarkers of response to niraparib. II. To evaluate genomic mechanisms of resistance following treatment benefit with niraparib. III. To evaluate previous treatment response as a marker of response to niraparib. OUTLINE: Patients receive niraparib orally (PO) once daily (QD). Cycles repeat every 28 days for 15 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years or until death. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Niraparib Tosylate Monohydrate
Given PO
Other Name: Zejula
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Study Arms ICMJE | Experimental: Treatment (Niraparib)
Patients receive niraparib PO QD. Cycles repeat every 28 days for 15 months in the absence of disease progression or unacceptable toxicity.
Intervention: Drug: Niraparib Tosylate Monohydrate
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
22 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2025 | ||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05174455 | ||||
Other Study ID Numbers ICMJE | OSU-21214 NCI-2021-12582 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | James Chen, Ohio State University Comprehensive Cancer Center | ||||
Study Sponsor ICMJE | Ohio State University Comprehensive Cancer Center | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Ohio State University Comprehensive Cancer Center | ||||
Verification Date | December 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |