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

Part of paid clinical trials in La Jolla, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02498613
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Malignant Solid Neoplasm
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Lung Small Cell Carcinoma
  • Metastatic Pancreatic Adenocarcinoma
  • Metastatic Triple-Negative Breast Carcinoma
  • Pancreatic Ductal Adenocarcinoma
  • Stage III Breast Cancer AJCC v7
  • Stage III Lung Non-Small Cell Cancer AJCC v7
  • Stage III Lung Small Cell Carcinoma AJCC v7
  • Stage III Pancreatic Cancer AJCC v6 and v7
  • Stage IIIA Breast Cancer AJCC v7
  • Stage IIIA Lung Non-Small Cell Cancer AJCC v7
  • Stage IIIA Lung Small Cell Carcinoma AJCC v7
  • Stage IIIB Breast Cancer AJCC v7
  • Stage IIIB Lung Non-Small Cell Cancer AJCC v7
  • Stage IIIB Lung Small Cell Carcinoma AJCC v7
  • Stage IIIC Breast Cancer AJCC v7
  • Stage IV Breast Cancer AJCC v6 and v7
  • Stage IV Lung Non-Small Cell Cancer AJCC v7
  • Stage IV Lung Small Cell Carcinoma AJCC v7
  • Stage IV Pancreatic Cancer AJCC v6 and v7
  • Triple-Negative Breast Carcinoma
  • Unresectable Lung Small Cell Carcinoma
  • Unresectable Pancreatic Adenocarcinoma
  • Unresectable Pancreatic Carcinoma
  • Unresectable Triple-Negative Breast Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 18F-Fluoromisonidazole — OTHER
    Correlative studies
  • Cediranib Maleate — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Olaparib — DRUG
    Given PO
  • Positron Emission Tomography — PROCEDURE
    Correlative studies

Study Details

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 (advanced/metastatic) or cannot be removed by surgery (unresectable), 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.

Key Dates

Start date
Aug 31, 2016
Status verified
Mar 2026
Primary completion
Jun 22, 2022
Completion
Apr 10, 2027

Study Design

Enrollment
122 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cediranib maleate, olaparib)
    Patients receive cediranib maleate PO QD on day 1. Patients undergoing FMISO scan also receive olaparib PO BID beginning the day after the second FMISO scan and the rest of the patients receive olaparib PO BID beginning day 4 of cycle 1. Cycles repeat every 28 days (35 days for cycle 1) in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Up to 4 weeks after completion of study treatment (Up to 43 months) ]

Locations (14)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UC San Diego Medical Center - HillcrestSan DiegoCalifornia92103-
UCSF Medical Center-Mount ZionSan FranciscoCalifornia94115-
Smilow Cancer Center/Yale-New Haven HospitalNew HavenConnecticut06510-
Yale UniversityNew HavenConnecticut06520-
Moffitt Cancer CenterTampaFlorida33612-
Moffitt Cancer Center-International PlazaTampaFlorida33607-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-
Weisberg Cancer Treatment CenterFarmington HillsMichigan48334-
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
M D Anderson Cancer CenterHoustonTexas77030-
VCU Massey Comprehensive Cancer CenterRichmondVirginia23298-

Find similar trials in La Jolla, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
UC San Diego Moores Cancer Center· La Jolla, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUC San Diego Medical Center - Hillcrest· San Diego, CAUCSF Medical Center-Mount Zion· San Francisco, CASmilow Cancer Center/Yale-New Haven Hospital· New Haven, CTYale University· New Haven, CT

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