a study on BRCA1 wt Allele BRCA2 wt Allele Estrogen Receptor Negative HER2 Metastatic Pancreatic Adenocarcinoma Pancreatic Adenocarcinoma Progesterone Receptor Negative Breast Cancer Lung Cancer Pancreatic Cancer Solid Tumor
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 or cannot be removed by surgery, 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.
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), germline breast cancer, early onset 1/2 (BRCA1/2) wild type (wt), basaloid triple negative breast cancer (b-TNBC), pancreatic ductal adenocarcinoma (PDAC), and small cell lung cancer (SCLC). The responses will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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 determine progression free survival (PFS) in each tumor cohort.
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 BRCA1 expression in patients with NSCLC or basaloid TNBC at baseline and changes on 4 days of cediranib treatment in the NSCLC and TNBC cohorts.
IV. To evaluate hypoxia markers at baseline and changes on treatment with cediranib in tumor tissue in the NSCLC and TNBC cohorts.
V. To evaluate levels of angiogenesis/inflammatory markers including VEGF at baseline and on treatment.
VI. To evaluate levels of hypoxia-related microribonucleic acids (miRNAs) at baseline and on treatment.
Patients receive cediranib maleate orally (PO) once daily (QD) for 3-4 days and then undergo biopsy. After biopsy, patients continue to receive cediranib maleate PO QD and begin olaparib PO twice daily (BID) beginning on the day after the post-dose biopsy (days 4-7) or by day 8 of course 1 (biopsy cohorts-NSCLC and TNBC) or day 4 of course 1 (non-biopsy cohorts-PDAC and SCLC). Courses repeat every 28 days (35 days for course 1) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
BRCA1 wt Allele BRCA2 wt Allele Estrogen Receptor Negative HER2/Neu Negative Metastatic Pancreatic Adenocarcinoma Pancreatic Adenocarcinoma Progesterone Receptor Negative Recurrent Breast Carcinoma Recurrent Non-Small Cell Lung Carcinoma Recurrent Pancreatic Carcinoma Recurrent Small Cell Lung Carcinoma Stage III Breast Cancer Stage III Non-Small Cell Lung Cancer Stage III Pancreatic Cancer Stage III Small Cell Lung Carcinoma Stage IIIA Breast Cancer Stage IIIA Non-Small Cell Lung Cancer Stage IIIA Small Cell Lung Carcinoma Stage IIIB Breast Cancer Stage IIIB Non-Small Cell Lung Cancer Stage IIIB Small Cell Lung Carcinoma Stage IIIC Breast Cancer Stage IV Breast Cancer Stage IV Non-Small Cell Lung Cancer Stage IV Pancreatic Cancer Stage IV Small Cell Lung Carcinoma Triple-Negative Breast Carcinoma Olaparib Cediranib Misonidazole Maleic acid
Open to people ages 18 years and up
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