Phase 2 Study of Cediranib and Olaparib for Advanced Solid Tumors
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02498613
This clinical trial is testing a combination of two drugs, cediranib and olaparib, to see if they can help treat advanced solid tumors, including breast, lung, and pancreatic cancers, that have spread or cannot be removed by surgery.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if the combination of cediranib and olaparib can stop the growth of advanced solid tumors by blocking certain enzymes needed for tumor growth. Cediranib may also reduce the tumor's blood supply, making it more sensitive to olaparib. The trial includes patients with various cancers such as breast, lung, and pancreatic cancer that have spread or cannot be surgically removed.
Description
The main goal of this study is to see how well the combination of cediranib and olaparib works in shrinking tumors in patients with advanced cancers like non-small cell lung cancer, triple-negative breast cancer, pancreatic cancer, and small cell lung cancer. Researchers will also look at how safe and tolerable the treatment is for patients.
Participants will take cediranib once a day and olaparib twice a day. The treatment cycles last 28 days, with the first cycle being 35 days. Patients will continue the treatment as long as it is effective and does not cause unacceptable side effects.
After finishing the treatment, patients will be monitored for four weeks. If they stop the treatment for reasons other than disease progression or withdrawal, they will continue to be monitored every four weeks until their disease progresses, they start a new therapy, or they pass away.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic cancer that cannot be removed by surgery, including non-small cell lung cancer, triple-negative breast cancer, pancreatic cancer, or small cell lung cancer.
- Have received at least one prior treatment for advanced cancer.
- Have measurable disease according to specific medical criteria.
- Be in relatively good health with a performance status score of 0, 1, or 2.
- Have a life expectancy of at least 4 months.
- Meet specific blood count and organ function requirements.
- Be able to take oral medications and not have any conditions that would prevent absorption of the study drugs.
- Have controlled blood pressure and thyroid function.
- Agree to use effective contraception during the study and for a period after the study.
- Be 18 years or older and able to understand and sign a consent form.
Exclusion Criteria
- Have had chemotherapy or radiation therapy within 3 weeks before starting the study drugs.
- Have untreated or symptomatic brain metastases or spinal cord compression.
- Have received certain other investigational drugs recently.
- Have a history of allergic reactions to similar drugs.
- Be taking medications that strongly affect liver enzymes.
- Have other serious medical conditions that could interfere with the study.
- Have had a heart attack or stroke within the past 6 months.
- Be pregnant or breastfeeding.
- Have HIV and are on antiretroviral therapy.
- Have any condition that the study doctor believes would interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UC San Diego Moores Cancer Center | 92093 | La Jolla | California |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| UC San Diego Medical Center - Hillcrest | 92103 | San Diego | California |
| UCSF Medical Center-Mount Zion | 94115 | San Francisco | California |
| Smilow Cancer Center/Yale-New Haven Hospital | 06510 | New Haven | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
| Moffitt Cancer Center-International Plaza | 33607 | Tampa | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Wayne State University/Karmanos Cancer Institute | 48201 | Detroit | Michigan |
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