A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 121
Summary
- Conditions
- Stage III Pancreatic Cancer AJCC v6 and v7
- Metastatic Lung Non-Small Cell Carcinoma
- Stage IV Lung Non-Small Cell Cancer AJCC v7
- Stage IV Lung Small Cell Carcinoma AJCC v7
- Stage IIIB Lung Non-Small Cell Cancer AJCC v7
- Unresectable Lung Small Cell Carcinoma
- Metastatic Lung Small Cell Carcinoma
- Metastatic Pancreatic Adenocarcinoma
- Metastatic Triple-Negative Breast Carcinoma
- Stage IIIC Breast Cancer AJCC v7
- Unresectable Triple-Negative Breast Carcinoma
- Pancreatic Ductal Adenocarcinoma
- Stage III Breast Cancer AJCC v7
- Stage IV Breast Cancer AJCC v6 and v7
- Stage IV Pancreatic Cancer AJCC v6 and v7
- Stage IIIA Lung Small Cell Carcinoma AJCC v7
- Stage IIIB Breast Cancer AJCC v7
- Stage III Lung Non-Small Cell Cancer AJCC v7
- Triple-Negative Breast Carcinoma
- Unresectable Pancreatic Carcinoma
- Unresectable Pancreatic Adenocarcinoma
- Stage III Lung Small Cell Carcinoma AJCC v7
- Stage IIIA Breast Cancer AJCC v7
- Stage IIIA Lung Non-Small Cell Cancer AJCC v7
- Stage IIIB Lung Small Cell Carcinoma AJCC v7
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 d...
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 and then every 4 weeks thereafter.
Tracking Information
- NCT #
- NCT02498613
- Collaborators
- AstraZeneca
- Investigators
- Principal Investigator: Joseph W Kim Yale University Cancer Center LAO
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