Trial Outcomes & Findings for Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma (NCT NCT01583543)
NCT ID: NCT01583543
Last Updated: 2017-05-19
Results Overview
Number of participants with objective response rate as defined as PR+CR as determined by RECIST vs. 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
2 years
Results posted on
2017-05-19
Participant Flow
Participant milestones
| Measure |
Olaparib
Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma
Baseline characteristics by cohort
| Measure |
Olaparib
n=12 Participants
Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
|
|---|---|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 15.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsNumber of participants with objective response rate as defined as PR+CR as determined by RECIST vs. 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Olaparib
n=12 Participants
Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
|
|---|---|
|
Objective Response Rate of Olaparib
|
0 Participants
|
SECONDARY outcome
Timeframe: Two yearsNumber of patients with progression free survival after two years from starting the trial.
Outcome measures
| Measure |
Olaparib
n=12 Participants
Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
|
|---|---|
|
Progression-Free Survival
|
0 Participants
|
SECONDARY outcome
Timeframe: Two yearsNumber of patients survived for 2 years after enrolling onto this study.
Outcome measures
| Measure |
Olaparib
n=12 Participants
Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
|
|---|---|
|
Overall Survival
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsAdverse events were graded according to CTCAE v.4 (Common Terminology Criteria for Adverse Events). Events are graded on a scale of 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = fatal. Only events that are clinically significant and which the treating investigator considers to be related to administration of olaparib are counted for this outcome measure.
Outcome measures
| Measure |
Olaparib
n=12 Participants
Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
|
|---|---|
|
Number of Participants Experiencing a Grade 3 or 4 Clinically Significant and Related Adverse Event
|
4 Participants
|
Adverse Events
Olaparib
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olaparib
n=12 participants at risk
400 mg PO BID Continuous Olaparib
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
General disorders
Death
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
Other adverse events
| Measure |
Olaparib
n=12 participants at risk
400 mg PO BID Continuous Olaparib
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
41.7%
5/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Stomach pain
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
4/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
Sensitive teeth
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
General disorders
Edema - limbs
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
General disorders
Fatigue
|
25.0%
3/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
General disorders
Fever
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
General disorders
Pain
|
33.3%
4/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Immune system disorders
Allergies
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Infections and infestations
Upper respiratory infection
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Infections and infestations
Infection, other
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Food poisoning
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Investigations
Lymphopenia
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Investigations
Thrombocytopenia
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
Urinary hesitancy
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Metabolism and nutrition disorders
Polydipsia
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain - other
|
25.0%
3/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Nervous system disorders
headache
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Reproductive system and breast disorders
Perinea/ Genital numbness
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
3/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
2/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Vascular disorders
Flushing
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Vascular disorders
Hot flashes
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
|
Vascular disorders
Lymphedema
|
8.3%
1/12 • From initiation of study drug, throughout the study, and for 30 days after the last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place