Olaparib for Pancreatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pancreatic Cancer+14 MoreOlaparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding olaparib after surgery and chemo helps treat pancreatic cancer with a pathogenic mutation in BRCA1, BRCA2, or PALB2.

Eligible Conditions
  • Pancreatic Cancer
  • Pancreatic Adenosquamous Carcinoma
  • Pancreatic Squamous Cell Carcinoma
  • Stage IB Pancreatic Cancer
  • Stage IA Pancreatic Cancer
  • Stage IIA Pancreatic Cancer
  • Stage IIB Pancreatic Cancer
  • Stage I Pancreatic Cancer
  • Stage II Pancreatic Cancer
  • Stage 0 Pancreatic Cancer
  • Pancreatic Acinar Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 10 years

At time of study enrollment
RFS and OS differences in patients who had R1 vs R0 resections
CA-19-9 Antigen
RFS and OS differences in patients who had lymph node positivity at resection
Month 44
Improvement in relapse-free survival (RFS)
Year 5
RFS
Pharmacotherapy
RFS in those who received any platinum-based perioperative chemotherapy versus no platinum-based perioperative chemotherapy
Year 10
OS in those who received =< 3 months of perioperative platinum chemotherapy versus > 3 months of perioperative platinum chemotherapy
OS in those who received any platinum-based perioperative chemotherapy versus no platinum-based perioperative chemotherapy
Overall survival (OS)
Up to 10 years
Differences in survival
Efficacy of olaparib after chemotherapy in patients with a pathogenic germline BRCA or PALB2 mutation
RFS and OS differences with those who had resectable disease at diagnosis

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

sBRCAm
51%Nausea
40%Fatigue
35%Anaemia
25%Vomiting
22%Abdominal pain
20%Asthenia
16%Diarrhoea
15%Constipation
15%Dyspepsia
13%Decreased appetite
11%Oedema peripheral
11%Urinary tract infection
11%Thrombocytopenia
11%Upper respiratory tract infection
11%Arthralgia
9%Musculoskeletal pain
9%Cough
7%Alopecia
7%Back pain
7%Neutropenia
7%Abdominal pain upper
7%Dyspnoea
7%Insomnia
5%Anxiety
5%Nasopharyngitis
5%Respiratory tract infection
5%Headache
5%Depression
5%Blood creatinine increased
5%Rash
5%Glomerular filtration rate decreased
5%Mucosal inflammation
5%Vitamin d deficiency
5%Dysgeusia
5%Pruritus
5%Hypertension
4%Neutrophil count decreased
4%White blood cell count decreased
4%Pain in extremity
4%Leukopenia
4%Dizziness
4%Abdominal distension
4%Influenza like illness
4%Hypomagnesaemia
4%Pyrexia
4%Peripheral swelling
2%Platelet count decreased
2%Muscle spasms
2%Biliary colic
2%Atrial fibrillation
2%Cardiac failure
2%Deep vein thrombosis
2%Small intestinal obstruction
2%Metastases to central nervous system
2%Bronchitis
2%Alanine aminotransferase increased
2%Myalgia
2%Oropharyngeal pain
2%Dysarthria
2%Contrast media allergy
2%Femoral neck fracture
2%Colonic abscess
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT02476968) in the sBRCAm ARM group. Side effects include: Nausea with 51%, Fatigue with 40%, Anaemia with 35%, Vomiting with 25%, Abdominal pain with 22%.

Trial Design

2 Treatment Groups

Arm I (olaparib)
1 of 2
Arm II (placebo)
1 of 2

Experimental Treatment

Non-Treatment Group

152 Total Participants · 2 Treatment Groups

Primary Treatment: Olaparib · Has Placebo Group · Phase 2

Arm I (olaparib)
Drug
Experimental Group · 1 Intervention: Olaparib · Intervention Types: Drug
Arm II (placebo)
Drug
PlaceboComparator Group · 1 Intervention: Placebo Administration · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,071 Previous Clinical Trials
41,128,701 Total Patients Enrolled
Kim A Reiss BinderPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Inclusion criteria: Patient has been hospitalized for an acute illness or injury.
Patient must have undergone at least 3 combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy.
You 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.
Patient must be planning to receive, be receiving or have received at least three combined months (i.e.
You are 12 weeks or less from your most recent treatment.