Trial Outcomes & Findings for Olaparib in Treating Patients With Stage IV Pancreatic Cancer (NCT NCT02677038)
NCT ID: NCT02677038
Last Updated: 2024-10-01
Results Overview
The primary endpoint was the objective response rate assessed by the investigator using the modified RECIST v1.1 criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
5 years 8 months
Results posted on
2024-10-01
Participant Flow
24 patients were recruited at MD Anderson Cancer Center Houston Tx USA
Participant milestones
| Measure |
Olaparib Monotherapy in Advanced Previously Treated PDAC With BRCAness
Eligible patients received 300mg Olaperib tablet twice daily until investigator assessed objective radiologic disease progression, toxic effects or patient withdrawal.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Olaparib Monotherapy in Advanced Previously Treated PDAC With BRCAness
Eligible patients received 300mg Olaperib tablet twice daily until investigator assessed objective radiologic disease progression, toxic effects or patient withdrawal.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Olaparib in Treating Patients With Stage IV Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Olaparib Monotherapy in Advanced Previously Treated PDAC With BRCAness
n=22 Participants
Eligible patients received 300mg Olaperib tablet twice daily until investigator assessed objective radiologic disease progression, toxic effects or patient withdrawal.
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 years 8 monthsThe primary endpoint was the objective response rate assessed by the investigator using the modified RECIST v1.1 criteria.
Outcome measures
| Measure |
Olaparib Monotherapy in Advanced Previously Treated PDAC With BRCAness
n=22 Participants
Eligible patients received 300mg Olaperib tablet twice daily until investigator assessed objective radiologic disease progression, toxic effects or patient withdrawal.
|
|---|---|
|
Objective Response Rate
Partial Response
|
1 Participants
|
|
Objective Response Rate
Stable Disease
|
15 Participants
|
SECONDARY outcome
Timeframe: 5 years 8 monthsThe Progression Free Survival defined as the time from enrollment until radiologic disease progression and it is assessed by the investigator review using modified RECIST v1.1 criteria or by death by any cause. This was applied to all patients from MD Anderson Cancer Center Houston Tx USA.
Outcome measures
| Measure |
Olaparib Monotherapy in Advanced Previously Treated PDAC With BRCAness
n=22 Participants
Eligible patients received 300mg Olaperib tablet twice daily until investigator assessed objective radiologic disease progression, toxic effects or patient withdrawal.
|
|---|---|
|
Progression Free Survival
|
4.83 Months
Interval 3.61 to 7.82
|
SECONDARY outcome
Timeframe: 5 years 8 monthsOverall Survival is defined as the time from the date of enrollment to the date of death or last follow up. This was applied to all patients from MD Anderson Cancer Center Houston Tx USA
Outcome measures
| Measure |
Olaparib Monotherapy in Advanced Previously Treated PDAC With BRCAness
n=22 Participants
Eligible patients received 300mg Olaperib tablet twice daily until investigator assessed objective radiologic disease progression, toxic effects or patient withdrawal.
|
|---|---|
|
Overall Survival
|
16.1 Months
Interval 13.5 to
The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
|
Adverse Events
Olaparib Monotherapy in Advanced Previously Treated PDAC With BRCAness
Serious events: 0 serious events
Other events: 22 other events
Deaths: 10 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Olaparib Monotherapy in Advanced Previously Treated PDAC With BRCAness
n=22 participants at risk
Eligible patients received 300mg Olaperib tablet twice daily until investigator assessed objective radiologic disease progression, toxic effects or patient withdrawal.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
4.5%
1/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Abdominal pain
|
59.1%
13/22 • 5 years, 8 months
|
|
Investigations
Alanine aminotransferase increased
|
40.9%
9/22 • 5 years, 8 months
|
|
Investigations
Alkaline phosphatase increased
|
59.1%
13/22 • 5 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.5%
1/22 • 5 years, 8 months
|
|
Blood and lymphatic system disorders
Anemia
|
86.4%
19/22 • 5 years, 8 months
|
|
Metabolism and nutrition disorders
Anorexia
|
54.5%
12/22 • 5 years, 8 months
|
|
Psychiatric disorders
Anxiety
|
18.2%
4/22 • 5 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.7%
5/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Ascites
|
4.5%
1/22 • 5 years, 8 months
|
|
Investigations
Aspartate aminotransferase increased
|
40.9%
9/22 • 5 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.9%
9/22 • 5 years, 8 months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
4.5%
1/22 • 5 years, 8 months
|
|
Infections and infestations
Biliary tract infection
|
4.5%
1/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Bloating
|
9.1%
2/22 • 5 years, 8 months
|
|
Investigations
Blood bilirubin increased
|
13.6%
3/22 • 5 years, 8 months
|
|
Injury, poisoning and procedural complications
Bruising
|
4.5%
1/22 • 5 years, 8 months
|
|
Cardiac disorders
Chest pain - cardiac
|
9.1%
2/22 • 5 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.5%
1/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Chills
|
22.7%
5/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Colitis
|
4.5%
1/22 • 5 years, 8 months
|
|
Infections and infestations
Conjunctivitis
|
4.5%
1/22 • 5 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
4/22 • 5 years, 8 months
|
|
Investigations
Creatinine increased
|
18.2%
4/22 • 5 years, 8 months
|
|
Psychiatric disorders
Depression
|
4.5%
1/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
11/22 • 5 years, 8 months
|
|
Nervous system disorders
Dizziness
|
40.9%
9/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
4.5%
1/22 • 5 years, 8 months
|
|
Nervous system disorders
Dysgeusia
|
4.5%
1/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Dyspepsia
|
13.6%
3/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
1/22 • 5 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.7%
5/22 • 5 years, 8 months
|
|
General disorders
Edema limbs
|
13.6%
3/22 • 5 years, 8 months
|
|
General disorders
Edema trunk
|
4.5%
1/22 • 5 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
2/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Esophagitis
|
4.5%
1/22 • 5 years, 8 months
|
|
General disorders
Fatigue
|
100.0%
22/22 • 5 years, 8 months
|
|
General disorders
Fever
|
18.2%
4/22 • 5 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.5%
1/22 • 5 years, 8 months
|
|
General disorders
Flu like symptoms
|
4.5%
1/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Gastritis
|
4.5%
1/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
13.6%
3/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
4.5%
1/22 • 5 years, 8 months
|
|
General disorders
General disorders and administration site conditions - (Other), specify
|
4.5%
1/22 • 5 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
13.6%
3/22 • 5 years, 8 months
|
|
Investigations
GGT increased
|
54.5%
12/22 • 5 years, 8 months
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • 5 years, 8 months
|
|
Renal and urinary disorders
Hematuria
|
9.1%
2/22 • 5 years, 8 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - (Other), specify
|
4.5%
1/22 • 5 years, 8 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
13.6%
3/22 • 5 years, 8 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
36.4%
8/22 • 5 years, 8 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
13.6%
3/22 • 5 years, 8 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
18.2%
4/22 • 5 years, 8 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
9.1%
2/22 • 5 years, 8 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.2%
4/22 • 5 years, 8 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.5%
1/22 • 5 years, 8 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.5%
1/22 • 5 years, 8 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
13.6%
3/22 • 5 years, 8 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
45.5%
10/22 • 5 years, 8 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.2%
4/22 • 5 years, 8 months
|
|
Psychiatric disorders
Insomnia
|
36.4%
8/22 • 5 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
4.5%
1/22 • 5 years, 8 months
|
|
General disorders
Localized edema
|
4.5%
1/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Mucositis oral
|
4.5%
1/22 • 5 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness trunk
|
4.5%
1/22 • 5 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.6%
3/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Nausea
|
72.7%
16/22 • 5 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.1%
2/22 • 5 years, 8 months
|
|
Investigations
Neutrophil count decreased
|
13.6%
3/22 • 5 years, 8 months
|
|
General disorders
Non-cardiac chest pain
|
4.5%
1/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Oral pain
|
4.5%
1/22 • 5 years, 8 months
|
|
General disorders
Pain
|
22.7%
5/22 • 5 years, 8 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.7%
5/22 • 5 years, 8 months
|
|
Cardiac disorders
Palpitations
|
4.5%
1/22 • 5 years, 8 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
9.1%
2/22 • 5 years, 8 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
13.6%
3/22 • 5 years, 8 months
|
|
Investigations
Platelet count decreased
|
31.8%
7/22 • 5 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
4.5%
1/22 • 5 years, 8 months
|
|
Nervous system disorders
Presyncope
|
4.5%
1/22 • 5 years, 8 months
|
|
Renal and urinary disorders
Proteinuria
|
13.6%
3/22 • 5 years, 8 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
2/22 • 5 years, 8 months
|
|
Psychiatric disorders
Psychiatric disorders - (Other), specify
|
4.5%
1/22 • 5 years, 8 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.7%
5/22 • 5 years, 8 months
|
|
Cardiac disorders
Sinus bradycardia
|
9.1%
2/22 • 5 years, 8 months
|
|
Nervous system disorders
Somnolence
|
4.5%
1/22 • 5 years, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
13.6%
3/22 • 5 years, 8 months
|
|
Vascular disorders
Thromboembolic event
|
4.5%
1/22 • 5 years, 8 months
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
4.5%
1/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
4.5%
1/22 • 5 years, 8 months
|
|
Renal and urinary disorders
Urinary frequency
|
13.6%
3/22 • 5 years, 8 months
|
|
Infections and infestations
Urinary tract infection
|
4.5%
1/22 • 5 years, 8 months
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
6/22 • 5 years, 8 months
|
|
Investigations
Weight loss
|
18.2%
4/22 • 5 years, 8 months
|
|
Investigations
White blood cell decreased
|
18.2%
4/22 • 5 years, 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place