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

Official Title

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


This phase II trial studies cediranib maleate in combination with olaparib in treating patients with solid tumours 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 tumour cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may also block the flow of oxygen to the tumour, and may help make the tumour more sensitive to olaparib.

Trial Description

Primary Outcome:

  • Objective response rate
Secondary Outcome:
  • Incidence of adverse events
  • Progression-free survival
  • To determine the objective response rate (ORR) of cediranib (cediranib maleate) plus olaparib in combination in patients with advanced or metastatic solid tumours of the following tumour types: non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic ductal adenocarcinoma (PDAC), and small cell lung cancer (SCLC).
  • To assess the safety and tolerability of oral administration of cediranib in combination with olaparib in patients with select advanced solid tumours.
  • To estimate progression free survival (PFS) in each tumour cohort.
  • To estimate the prevalence of the mutations of deoxyribonucleic acid (DNA) repair genes in tumours using the BROCA panel and to correlate tumour regression with mutations status. (Integrated)
  • To evaluate changes in tumour hypoxia on cediranib treatment compared to baseline by [F-18] fluoromisonidazole (FMISO) positron emission tomography/computed tomography (PET/CT) in patients with NSCLC.
  • To evaluate levels of angiogenesis/inflammatory markers including VEGF at baseline and on treatment.
  • To evaluate levels of circulating tumour deoxyribonucleic acid (ctDNA) at baseline and on treatment.
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 and then every 4 weeks thereafter.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.


Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society