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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

ConditionsPancreatic Acinar Cell CarcinomaPancreatic Adenosquamous CarcinomaPancreatic Squamous Cell CarcinomaResectable Pancreatic Acinar Cell CarcinomaResectable Pancreatic AdenocarcinomaResectable Pancreatic Adenosquamous CarcinomaResectable Pancreatic Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

STEP 0 (PRE-REGISTRATION) INCLUSION CRITERIA

Patient must be >= 18 years of age on day of consent

Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or CT/MRI

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo CT/MRI

  • Olaparib

    Drug

    Given PO

  • Placebo Administration

    Drug

    Given PO

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: Arm I (olaparib)Experimental treatment 4 interventions
Group B: Arm II (placebo)Placebo comparator 4 interventions

Trial outcomes

Primary outcomes

1

Improvement in relapse-free survival (RFS)

Will demonstrate an improvement in the RFS from 22 months to 44 months (hazard ratio 0.5) in patients treated with olaparib after perioperative (neoadjuvant, adjuvant or a combination) chemotherapy compared to those treated with perioperative therapy alone.

Time frame
From randomization to first documentation of disease recurrence (primary tumor relapse) or death, assessed from 22 months to 44 months

Secondary outcomes

1

RFS

Will 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. Analysis will be largely exploratory. Within each arm any proportion endpoint (toxicity, mutation rate, etc.) will be estimable with a 95% confidence interval. Arm A would have a confidence interval that is 20 percentage points wide, and Arm B would have a confidence interval that is 29 percentage points wide.

Time frame
From randomization to first documentation of disease recurrence (primary tumor relapse) or death, assessed up to 5 years
2

Overall survival (OS)

Analysis will be largely exploratory. Power for overall survival in particular will be limited. Within each arm any proportion endpoint (toxicity, mutation rate, etc.) will be estimable with a 95% confidence interval. Arm A would have a confidence interval that is 20 percentage points wide, and Arm B would have a confidence interval that is 29 percentage points wide.

Time frame
From randomization until 10 years after registration or until death, whichever comes first
3

Efficacy of olaparib after chemotherapy in patients with a pathogenic germline BRCA or PALB2 mutation

Will analyze the efficacy of olaparib after chemotherapy in patients with a pathogenic germline BRCA or PALB2 mutation compared to those with a somatic mutation.

Time frame
Up to 10 years
4

Differences in survival

Will analyze survival differences between patients who received neoadjuvant or perioperative chemotherapy compared to those who received adjuvant therapy alone.

Time frame
Up to 10 years

Other outcomes

1

RFS and OS differences in patients who had R1 vs R0 resections

Time frame
Up to 10 years
2

RFS and OS differences in patients who had lymph node positivity at resection

Time frame
Up to 10 years
3

RFS and OS differences in patients who had elevated or rising CA 19-9 or CEA

A cutoff of 35 will be used to determine elevated versus normal CA 19-9 (i.e., greater than 35 will be considered elevated), and the cutoff for CEA will be based on the treating institution's definition of the upper limit of normal. Univariate differences by marker status will be analyzed and Cox proportional hazards models will be fit, adjusting for other clinical and demographic factors that may be confounders.

Time frame
Up to 10 years
4

RFS and OS differences with those who had resectable disease at diagnosis

Will be compared to those who did not.

Time frame
Up to 10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov
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