Cediranib + Olaparib for Cancer

Recruiting at16 trial locations

Overseen by Joseph W. Kim, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Joseph W. Kim, MD

Principal Investigator

Yale University Cancer Center LAO

Eligibility Criteria

This trial is for adults with advanced or inoperable solid tumors, including breast, non-small cell lung, small cell lung, and pancreatic cancers. Participants must have had at least one standard treatment previously and be able to take oral medication. They should not be pregnant or breastfeeding and must use effective contraception. People with recent significant bleeding, heart issues, other invasive cancers within the last 3 years, untreated brain metastases, or those on certain drugs affecting liver enzymes are excluded.

Inclusion Criteria

You need to have certain levels of blood cells and chemicals in your blood for this study.

The effects of cediranib and olaparib on the developing human fetus are unknown; adequate contraception is required

You have been diagnosed with certain types of cancer that has spread or cannot be removed with surgery.

Exclusion Criteria

Any condition that, in the opinion of the treating investigator would interfere with evaluation of the investigational product or interpretation of subject safety or study results

You are using natural herbal products, alternative medications, or folk remedies.

You have had a significant amount of coughing up blood or bleeding in the past month.

Treatment Details

Interventions

• Cediranib Maleate (Angiogenesis Inhibitor)
• Olaparib (PARP Inhibitor)

Trial Overview The study tests a combination of two drugs: Cediranib Maleate and Olaparib in patients with various advanced solid tumors. The goal is to see if these drugs can stop tumor growth by inhibiting specific enzymes needed for cell proliferation and cutting off oxygen supply to the tumor cells.

Participant Groups

Group I: Treatment (cediranib maleate, olaparib) Experimental Treatment 5 Interventions

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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology