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PARP Inhibitor

Olaparib for Pancreatic Cancer

Phase 2
Waitlist Available
Led By Milind Javle
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from date of study entry to the date of death from any cause or to the date of last follow-up if patients are alive, assessed up to 3 years
Awards & highlights

Study Summary

This study is evaluating whether olaparib is effective in treating patients with stage IV pancreatic cancer.

Eligible Conditions
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from date of study entry to the date of death from any cause or to the date of last follow-up if patients are alive, assessed up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from date of study entry to the date of death from any cause or to the date of last follow-up if patients are alive, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (defined as complete response or partial response) assessed using Response Evaluation Criteria in Solid Tumors 1.1
Secondary outcome measures
Change in cancer antigen 19-9 (CA19-9) clinical response
Incidence of unacceptable toxicity
Overall survival (OS)
+1 more

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Hyperglycaemia
9%
Aspartate aminotransferase increased
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (olaparib)Experimental Treatment1 Intervention
Patients receive olaparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,298 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,882 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,267 Previous Clinical Trials
288,611,958 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Olaparib in Treating Patients With Stage IV Pancreatic Cancer
2016. "Olaparib in Treating Patients With Stage IV Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02677038.
~3 spots leftby Apr 2025
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