Last updated on December 2018

A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors


Brief description of study

This phase II trial studies cediranib maleate in combination with olaparib in treating patients with solid tumors that have spread to other parts of the body or cannot be removed by surgery, including breast cancer, non-small cell lung cancer, small cell lung cancer, and pancreatic cancer. Cediranib maleate and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may also block the flow of oxygen to the tumor, and may help make the tumor more sensitive to olaparib.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To determine the objective response rate (ORR) of cediranib (cediranib maleate) plus olaparib in combination in patients with advanced or metastatic solid tumors of the following tumor types: non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic ductal adenocarcinoma (PDAC), and small cell lung cancer (SCLC).

SECONDARY OBJECTIVES:

I. To assess the safety and tolerability of oral administration of cediranib in combination with olaparib in patients with select advanced solid tumors.

II. To estimate progression free survival (PFS) in each tumor cohort.

TERTIARY OBJECTIVES:

I. To estimate the prevalence of the mutations of deoxyribonucleic acid (DNA) repair genes in tumors using the BROCA panel and to correlate tumor regression with mutations status. (Integrated) II. To evaluate changes in tumor hypoxia on cediranib treatment compared to baseline by [F-18] fluoromisonidazole (FMISO) positron emission tomography/computed tomography (PET/CT) in patients with NSCLC.

III. To evaluate levels of angiogenesis/inflammatory markers including VEGF at baseline and on treatment.

IV. To evaluate levels of circulating tumor deoxyribonucleic acid (ctDNA) at baseline and on treatment.

OUTLINE

Patients receive cediranib maleate orally (PO) once daily (QD) on day 1. Patients undergoing FMISO scan also receive olaparib PO twice daily (BID) beginning the day after the second FMISO scan and the rest of the patients receive olaparib PO BID beginning day 4 of course 1. Courses repeat every 28 days (35 days for course 1) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks and then every 4 weeks thereafter.

Clinical Study Identifier: NCT02498613

Contact Investigators or Research Sites near you

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Shumei Kato

UC San Diego Moores Cancer Center
La Jolla, CA United States
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Shumei Kato

University of California San Diego
San Diego, CA United States
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Pamela N. Munster

UCSF Medical Center-Mount Zion
San Francisco, CA United States
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Joseph W. Kim

Smilow Cancer Center/Yale-New Haven Hospital
New Haven, CT United States
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Joseph W. Kim

Yale University
New Haven, CT United States
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Hatem H. Soliman

Moffitt Cancer Center
Tampa, FL United States
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Ulka N. Vaishampayan

Wayne State University/Karmanos Cancer Institute
Detroit, MI United States
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Dana B. Cardin

Vanderbilt University/Ingram Cancer Center
Nashville, TN United States
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Siqing Fu

M D Anderson Cancer Center
Houston, TX United States
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Sosipatros A. Boikos

Virginia Commonwealth University/Massey Cancer Center
Richmond, VA United States
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Daniel J. Renouf

BCCA-Vancouver Cancer Centre
Vancouver, BC Canada
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University Health Network-Princess Margaret Hospital
Toronto, ON Canada
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Primo N. Lara

University of California Davis Comprehensive Cancer Center
Sacramento, CA United States
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Ulka N. Vaishampayan

Weisberg Cancer Treatment Center
Farmington Hills, MI United States
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Recruitment Status: Open


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