Pancreatic Ductal Adenocarcinoma Clinical Trial
Official title:
A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors
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.
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 | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05209074 -
Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
|
Phase 1 | |
| Recruiting |
NCT04969731 -
Safety and Efficacy of Immuncell-LC With Gemcitabine in Resectable Pancreatic Cancer
|
Phase 3 | |
| Recruiting |
NCT04927780 -
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
|
Phase 3 | |
| Recruiting |
NCT05048524 -
Peri-operative SLOG for Localized Pancreatic Cancer
|
Phase 2 | |
| Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03257150 -
A Study of the Use of Irreversible Electroporation in Pancreatic Ductal Cancer
|
N/A | |
| Terminated |
NCT04400903 -
Monitoring Heart Rate Variability for the Early Detection of Pancreatic Cancer
|
||
| Active, not recruiting |
NCT05462717 -
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT03267316 -
A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04970056 -
Pancreatic Cancer Early Detection Consortium
|
||
| Terminated |
NCT04046887 -
Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
|
Phase 1 | |
| Recruiting |
NCT05964621 -
Venous Thromboembolism in Primary Pancreatic Tumour Resection
|
||
| Active, not recruiting |
NCT04827953 -
Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04291651 -
UCSF PANC Cyst Registry
|
||
| Recruiting |
NCT05977322 -
A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.
|
Phase 1 | |
| Recruiting |
NCT05692596 -
The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics
|
||
| Active, not recruiting |
NCT04862260 -
Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma
|
Early Phase 1 | |
| Active, not recruiting |
NCT04853017 -
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
|
Phase 1 | |
| Completed |
NCT03770117 -
Study of the Effect of Prehabilitation on Markers of Sarcopenia in Patients Undergoing Pancreatoduodenectomy for Malignant Disease
|
||
| Completed |
NCT02259114 -
A Dose-Finding Study of Birabresib (MK-8628), a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Adults With Selected Advanced Solid Tumors (MK-8628-003)
|
Phase 1 |