Last updated on November 2018

Olaparib and Cediranib Maleate in Treating Patients With Recurrent Refractory or Metastatic Endometrial Cancer


Brief description of study

This randomized phase II trial studies how well olaparib and cediranib maleate work in treating patients with endometrial cancer that has come back, does not respond to treatment, or has spread to other places in the body. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single agent cediranib as measured by progression free survival (PFS), in patients with recurrent, persistent or metastatic endometrial cancer.

SECONDARY OBJECTIVES:

I. To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single-agent cediranib as measured by overall survival (OS) in patients with recurrent, persistent or metastatic endometrial cancer.

II. To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms may be added by subsequent amendment versus single-agent cediranib as measured by response rate in patients with recurrent, persistent or metastatic endometrial cancer.

III. To assess the safety and tolerability of single-agent cediranib, single-agent olaparib, and the combination of olaparib and cediranib (and potentially other combination arms may be added by subsequent amendment).

IV. To assess if mutations in deoxyribonucleic acid (DNA) homologous repair genes (assayed prior to all treatment and prior to the study treatment) are predictive of response to olaparib alone or in combination with cediranib. (Integrated Biomarker) V. To assess if markers of angiogenesis in serial plasma samples are associated with response to cediranib alone or in combination with olaparib. (Integrated Biomarker)

EXPLORTORY OBJECTIVES:

I. To compare the efficacy of the combination of olaparib and cediranib (and potentially other combination arms may be added by subsequent amendment) versus single agent olaparib as measured by PFS, response rate and OS, if and only if the combination is superior to the single-agent cediranib arm.

II. To assess if phosphatase and tensin homolog (PTEN) loss as assessed by immunohistochemistry (IHC) is predictive of response to olaparib alone or in combination with cediranib. (Exploratory Biomarker) III. To assess if loss of function of ARID1A assessed by immunohistochemistry (IHC) and mutational profile is predictive of response to olaparib alone or in combination with cediranib. (Exploratory Biomarker) IV. To assess if TP53 mutation status and p53 expression as assessed by IHC is associated with response to olaparib or in combination with cediranib. (Exploratory Biomarker) V. To assess if markers of angiogenesis in tissue are associated with response to cediranib alone or in combination with olaparib. (Exploratory Biomarker) VI. To assess if microsatellite instability (MSI) as assessed by loss of DNA mismatch repair (MMR) proteins is associated with response to olaparib alone or in combination with cediranib. (Exploratory Biomarker) VII. To assess if surrogate markers for the TCGA molecular subgroups p53 IHC, MSI, and mutational status of the exonuclease domain of polymerase-epsilon (POLE) are associated with response to treatment in all arms. (Exploratory Biomarker) VIII. To examine the association of the change in mutant allele frequency with response to treatment and to identify resistance mutations at the time of recurrence using ctDNA. (Exploratory Biomarker)

OUTLINE: Patients are randomized into 1 of 3 arms.

ARM I: Patients receive cediranib maleate orally (PO) once daily (QD). Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.

ARM II: Patients receive olaparib PO twice daily (BID). Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.

ARM III: Patients receive olaparib PO BID and cediranib maleate PO QD. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Clinical Study Identifier: NCT03660826

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Michael J. Callahan

Saint Vincent Hospital and Health Care Center
Indianapolis, IN United States
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Nicola M. Spirtos

Women's Cancer Center of Nevada
Las Vegas, NV United States
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Timothy D. Moore

Strecker Cancer Center-Belpre
Belpre, OH United States
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Timothy D. Moore

Adena Regional Medical Center
Chillicothe, OH United States
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Peter G. Rose

Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, OH United States
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Peter G. Rose

Cleveland Clinic Foundation
Cleveland, OH United States
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Timothy D. Moore

Mount Carmel East Hospital
Columbus, OH United States
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Timothy D. Moore

Columbus Oncology and Hematology Associates Inc
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Riverside Methodist Hospital
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Grant Medical Center
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Hillcrest Hospital Cancer Center
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Saint Francis Hospital
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Saint Francis Cancer Center
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Memorial Health University Medical Center
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Iowa Methodist Medical Center
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Medical Oncology and Hematology Associates-Des Moines
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Broadlawns Medical Center
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Iowa Lutheran Hospital
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Trinity Regional Medical Center
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Methodist West Hospital
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Ochsner Medical Center Jefferson
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Johns Hopkins University/Sidney Kimmel Cancer Center
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Nebraska Methodist Hospital
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Legacy Salmon Creek Hospital
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Good Samaritan Regional Health Center
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Ochsner Baptist Medical Center
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Saint Louis Cancer and Breast Institute-Ballwin
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MetroHealth Medical Center
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Reading Hospital
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Mary Bird Perkins Cancer Center
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Women's Cancer Care-Covington
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CHI Saint Vincent Cancer Center Hot Springs
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Cedars Sinai Medical Center
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Richard L. Deming

TriHealth Cancer Institute-Westside
Cincinnati, OH United States
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Richard L. Deming

TriHealth Cancer Institute-Anderson
Cincinnati, OH United States
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Howard M. Gross

Good Samaritan Hospital - Dayton
Dayton, OH United States
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Howard M. Gross

Miami Valley Hospital
Dayton, OH United States
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Howard M. Gross

Dayton Physicians LLC-Samaritan North
Dayton, OH United States
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Howard M. Gross

Samaritan North Health Center
Dayton, OH United States
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Howard M. Gross

Armes Family Cancer Center
Findlay, OH United States
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Howard M. Gross

Blanchard Valley Hospital
Findlay, OH United States
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Howard M. Gross

Orion Cancer Care
Findlay, OH United States
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Howard M. Gross

Atrium Medical Center-Middletown Regional Hospital
Franklin, OH United States
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Howard M. Gross

Dayton Physicians LLC-Atrium
Franklin, OH United States
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Howard M. Gross

Dayton Physicians LLC-Wayne
Greenville, OH United States
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Howard M. Gross

Wayne Hospital
Greenville, OH United States
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Howard M. Gross

Greater Dayton Cancer Center
Kettering, OH United States
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Howard M. Gross

First Dayton Cancer Care
Kettering, OH United States
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Howard M. Gross

Kettering Medical Center
Kettering, OH United States
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Howard M. Gross

Springfield Regional Cancer Center
Springfield, OH United States
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Howard M. Gross

Springfield Regional Medical Center
Springfield, OH United States
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Howard M. Gross

Dayton Physicians LLC-Upper Valley
Troy, OH United States
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Howard M. Gross

Upper Valley Medical Center
Troy, OH United States
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Maria C. Bell

Sanford Cancer Center Oncology Clinic
Sioux Falls, SD United States
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David C. Starks

Avera Cancer Institute
Sioux Falls, SD United States
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Maria C. Bell

Sanford USD Medical Center - Sioux Falls
Sioux Falls, SD United States
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Richard L. Deming

Memorial Hospital
Chattanooga, TN United States
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Richard L. Deming

Pulmonary Medicine Center of Chattanooga-Hixson
Hixson, TN United States
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Richard L. Deming

Memorial GYN Plus
Ooltewah, TN United States
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Richard L. Deming

Saint Joseph Regional Cancer Center
Bryan, TX United States
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Richard L. Deming

Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, WA United States
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Richard L. Deming

Harrison Medical Center
Bremerton, WA United States
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Richard L. Deming

Highline Medical Center-Main Campus
Burien, WA United States
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Richard L. Deming

Saint Elizabeth Hospital
Enumclaw, WA United States
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Richard L. Deming

Saint Francis Hospital
Federal Way, WA United States
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Richard L. Deming

Saint Clare Hospital
Lakewood, WA United States
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Richard L. Deming

Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, WA United States
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Richard L. Deming

Franciscan Research Center-Northwest Medical Plaza
Tacoma, WA United States
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Richard L. Deming

Northwest Medical Specialties PLLC
Tacoma, WA United States
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