A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors
Sponsor: AstraZeneca
This observational or N/A phase trial investigates Advanced Malignant Solid Neoplasm and Metastatic Lung Non-Small Cell Carcinoma and is currently ongoing. AstraZeneca leads this study, which shows 65 recorded versions since 2016 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)PRIMARY OBJECTIVE: 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. EXPLORATORY 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...
PRIMARY OBJECTIVE:
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.
EXPLORATORY 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 cycle 1. Cycles repeat every 28 days (35 days for cycle 1) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks. Patients who discontinue the study treatment for reasons other than disease progression or withdrawal of consent will continue to be followed every 4 weeks until disease progression, start of new therapy, or death, whichever occurs first.
Status Flow
Change History
65 versions recorded-
May 4, 2026 — Present [daily]
Active Not Recruiting
Phase: PHASE2 → None
-
Oct 2025 — May 2026 [monthly]
Active Not Recruiting PHASE2
-
Aug 2025 — Oct 2025 [monthly]
Active Not Recruiting PHASE2
-
Jun 2025 — Aug 2025 [monthly]
Active Not Recruiting PHASE2
-
Apr 2025 — Jun 2025 [monthly]
Active Not Recruiting PHASE2
▶ Show 60 earlier versions
-
Oct 2024 — Apr 2025 [monthly]
Active Not Recruiting PHASE2
-
Sep 2024 — Oct 2024 [monthly]
Active Not Recruiting PHASE2
-
Aug 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE2
-
Jul 2024 — Aug 2024 [monthly]
Active Not Recruiting PHASE2
-
May 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE2
Status: Terminated → Active Not Recruiting
-
Apr 2024 — May 2024 [monthly]
Terminated PHASE2
Status: Active Not Recruiting → Terminated
-
Dec 2023 — Apr 2024 [monthly]
Active Not Recruiting PHASE2
-
Oct 2023 — Dec 2023 [monthly]
Active Not Recruiting PHASE2
-
Sep 2023 — Oct 2023 [monthly]
Active Not Recruiting PHASE2
-
Aug 2023 — Sep 2023 [monthly]
Active Not Recruiting PHASE2
-
May 2023 — Aug 2023 [monthly]
Active Not Recruiting PHASE2
-
Feb 2023 — May 2023 [monthly]
Active Not Recruiting PHASE2
-
Dec 2022 — Feb 2023 [monthly]
Active Not Recruiting PHASE2
-
Sep 2022 — Dec 2022 [monthly]
Active Not Recruiting PHASE2
-
Jul 2022 — Sep 2022 [monthly]
Active Not Recruiting PHASE2
-
Jun 2022 — Jul 2022 [monthly]
Active Not Recruiting PHASE2
-
May 2022 — Jun 2022 [monthly]
Active Not Recruiting PHASE2
-
Mar 2022 — May 2022 [monthly]
Active Not Recruiting PHASE2
-
Feb 2022 — Mar 2022 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
-
Nov 2021 — Feb 2022 [monthly]
Recruiting PHASE2
-
Oct 2021 — Nov 2021 [monthly]
Recruiting PHASE2
-
Sep 2021 — Oct 2021 [monthly]
Recruiting PHASE2
-
May 2021 — Sep 2021 [monthly]
Recruiting PHASE2
-
Feb 2021 — May 2021 [monthly]
Recruiting PHASE2
-
Jan 2021 — Feb 2021 [monthly]
Recruiting PHASE2
-
Dec 2020 — Jan 2021 [monthly]
Recruiting PHASE2
-
Nov 2020 — Dec 2020 [monthly]
Recruiting PHASE2
-
Oct 2020 — Nov 2020 [monthly]
Recruiting PHASE2
-
Aug 2020 — Oct 2020 [monthly]
Recruiting PHASE2
-
Jul 2020 — Aug 2020 [monthly]
Recruiting PHASE2
-
Jun 2020 — Jul 2020 [monthly]
Recruiting PHASE2
-
May 2020 — Jun 2020 [monthly]
Recruiting PHASE2
-
Apr 2020 — May 2020 [monthly]
Recruiting PHASE2
-
Mar 2020 — Apr 2020 [monthly]
Recruiting PHASE2
-
Feb 2020 — Mar 2020 [monthly]
Recruiting PHASE2
-
Jan 2020 — Feb 2020 [monthly]
Recruiting PHASE2
-
Dec 2019 — Jan 2020 [monthly]
Recruiting PHASE2
-
Nov 2019 — Dec 2019 [monthly]
Recruiting PHASE2
-
Aug 2019 — Nov 2019 [monthly]
Recruiting PHASE2
-
Jul 2019 — Aug 2019 [monthly]
Recruiting PHASE2
-
Jun 2019 — Jul 2019 [monthly]
Recruiting PHASE2
-
May 2019 — Jun 2019 [monthly]
Recruiting PHASE2
-
Mar 2019 — May 2019 [monthly]
Recruiting PHASE2
-
Feb 2019 — Mar 2019 [monthly]
Recruiting PHASE2
-
Jan 2019 — Feb 2019 [monthly]
Recruiting PHASE2
-
Dec 2018 — Jan 2019 [monthly]
Recruiting PHASE2
-
Nov 2018 — Dec 2018 [monthly]
Recruiting PHASE2
-
Sep 2018 — Nov 2018 [monthly]
Recruiting PHASE2
-
Aug 2018 — Sep 2018 [monthly]
Recruiting PHASE2
-
Jul 2018 — Aug 2018 [monthly]
Recruiting PHASE2
-
Jun 2018 — Jul 2018 [monthly]
Recruiting PHASE2
-
May 2018 — Jun 2018 [monthly]
Recruiting PHASE2
-
Nov 2017 — May 2018 [monthly]
Recruiting PHASE2
-
Oct 2017 — Nov 2017 [monthly]
Recruiting PHASE2
-
Sep 2017 — Oct 2017 [monthly]
Recruiting PHASE2
-
Aug 2017 — Sep 2017 [monthly]
Recruiting PHASE2
-
Jun 2017 — Aug 2017 [monthly]
Recruiting PHASE2
-
May 2017 — Jun 2017 [monthly]
Recruiting PHASE2
-
Feb 2017 — May 2017 [monthly]
Recruiting PHASE2
-
Jan 2017 — Feb 2017 [monthly]
Recruiting PHASE2
First recorded
Aug 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
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.
Contact Information
- AstraZeneca
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .