Ignite Creation Date:
2024-05-06 @ 4:03 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04858334
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2021-04-23
Brief Title:
APOLLO A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1 BRCA2 or PALB2 Mutation
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
APOLLO A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1 BRCA2 or PALB2 Mutation
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed resected and has a pathogenic mutation in BRCA1 BRCA2 or PALB2 Olaparib is an inhibitor of PARP an enzyme that helps repair deoxyribonucleic acid DNA when it becomes damaged Blocking PARP may help keep tumor cells from repairing their damaged DNA causing them to die PARP inhibitors are a type of targeted therapy
Detailed Description:
PRIMARY OBJECTIVE
I To determine the relapse-free survival RFS-benefit from the addition of a maintenance olaparib following completion of chemotherapy in patients with resected pancreatic carcinoma and a pathogenic germline or somatic mutation in BRCA1 BRCA2 or PALB2
SECONDARY OBJECTIVES
I To evaluate RFS in patients with olaparib after perioperative chemotherapy compared to those treated with perioperative therapy alone among patients who received prior platinum-based perioperative chemotherapy
II To evaluate overall survival OS in patients treated with olaparib after adjuvant chemotherapy compared to those treated with adjuvant treatment alone
III To analyze the efficacy of olaparib after chemotherapy in patients with a pathogenic germline BRCA or PALB2 mutation compared to those with a somatic mutation
IV To analyze survival differences between patients who received neoadjuvant or perioperative chemotherapy compared to those who received adjuvant therapy alone
V To analyze RFS and OS differences in those who received 3 months of perioperative platinum chemotherapy compared to those who received 3 months of perioperative platinum chemotherapy
VI To analyze RFS and OS differences in those who received any platinum-based perioperative chemotherapy compared to no-platinum based perioperative chemotherapy
EXPLORATORY OBJECTIVES
I To analyze RFS and OS differences in patients who had R1 versus vs R0 resections lymph node positivity at resection andor elevated or rising CA 19-9 or CEA at time of study enrollment in the post-operative setting
II To analyze RFS and OS differences with those who had resectable disease at diagnosis compared to those who did not
III To analyze RFS and OS differences in those with gBRCA1 mutations compared to those with gBRCA2 mutations and gPALB2 mutations
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive olaparib orally PO twice daily BID on days 1-28 of each cycle Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo computed tomography CT scans or CTmagnetic resonance imaging MRI and collection of blood throughout the study
ARM II Patients receive placebo PO BID on days 1-28 of each cycle Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo CT scans or CTMRI and collection of blood throughout the study
After completion of study treatment patients are followed up at 30 days every 4 months for year 1 then every 6 months for years 2-10 after randomization
I To determine the relapse-free survival RFS-benefit from the addition of a maintenance olaparib following completion of chemotherapy in patients with resected pancreatic carcinoma and a pathogenic germline or somatic mutation in BRCA1 BRCA2 or PALB2
SECONDARY OBJECTIVES
I To evaluate RFS in patients with olaparib after perioperative chemotherapy compared to those treated with perioperative therapy alone among patients who received prior platinum-based perioperative chemotherapy
II To evaluate overall survival OS in patients treated with olaparib after adjuvant chemotherapy compared to those treated with adjuvant treatment alone
III To analyze the efficacy of olaparib after chemotherapy in patients with a pathogenic germline BRCA or PALB2 mutation compared to those with a somatic mutation
IV To analyze survival differences between patients who received neoadjuvant or perioperative chemotherapy compared to those who received adjuvant therapy alone
V To analyze RFS and OS differences in those who received 3 months of perioperative platinum chemotherapy compared to those who received 3 months of perioperative platinum chemotherapy
VI To analyze RFS and OS differences in those who received any platinum-based perioperative chemotherapy compared to no-platinum based perioperative chemotherapy
EXPLORATORY OBJECTIVES
I To analyze RFS and OS differences in patients who had R1 versus vs R0 resections lymph node positivity at resection andor elevated or rising CA 19-9 or CEA at time of study enrollment in the post-operative setting
II To analyze RFS and OS differences with those who had resectable disease at diagnosis compared to those who did not
III To analyze RFS and OS differences in those with gBRCA1 mutations compared to those with gBRCA2 mutations and gPALB2 mutations
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive olaparib orally PO twice daily BID on days 1-28 of each cycle Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo computed tomography CT scans or CTmagnetic resonance imaging MRI and collection of blood throughout the study
ARM II Patients receive placebo PO BID on days 1-28 of each cycle Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo CT scans or CTMRI and collection of blood throughout the study
After completion of study treatment patients are followed up at 30 days every 4 months for year 1 then every 6 months for years 2-10 after randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-05659 | REGISTRY | None | None |
| EA2192 | OTHER | None | None |
| EA2192 | OTHER | None | None |
| U10CA180820 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180820 |