Trial Outcomes & Findings for Osimertinib Study in Indian Patients (NCT NCT03853551)
NCT ID: NCT03853551
Last Updated: 2021-06-03
Results Overview
Number of Patients with treatment emergent Adverse Events
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
5 months
Results posted on
2021-06-03
Participant Flow
This was a prospective, open label, single arm, multicentre, India-specific Phase 4 study to investigate the safety of osimertinib 80 mg tablet in Indian adults with metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non small cell lung cancer (NSCLC). 60 Indian subjects were enrolled into the study.
Participant milestones
| Measure |
Single Arm
single arm, open label study and Osimertinib 80 mg tablet was given orally once daily.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Single Arm
single arm, open label study and Osimertinib 80 mg tablet was given orally once daily.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
7 patients discontinued the study because of disease progression.
|
7
|
Baseline Characteristics
Osimertinib Study in Indian Patients
Baseline characteristics by cohort
| Measure |
Single Arm
n=60 Participants
single arm, open label study and Osimertinib 80 mg tablet was given orally once daily.
|
|---|---|
|
Age, Continuous
|
58 Years
n=99 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian (Only Indian)
|
60 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 5 monthsNumber of Patients with treatment emergent Adverse Events
Outcome measures
| Measure |
Single Arm
n=60 Participants
single arm, open label study and Osimertinib 80 mg tablet was given orally once daily.
|
|---|---|
|
Safety of Osimertinib
|
60 Participants
|
Adverse Events
Single Arm
Serious events: 7 serious events
Other events: 51 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Single Arm
n=60 participants at risk
single arm, open label study and Osimertinib 80 mg tablet was given orally once daily.
|
|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.7%
1/60 • Number of events 1 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
2/60 • Number of events 2 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Eye disorders
Cataract
|
1.7%
1/60 • Number of events 1 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.7%
1/60 • Number of events 1 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
1.7%
1/60 • Number of events 1 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/60 • Number of events 1 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
1/60 • Number of events 1 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
General disorders
Mucosal inflammation
|
1.7%
1/60 • Number of events 1 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Infections and infestations
Dengue fever
|
1.7%
1/60 • Number of events 1 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
General disorders
Disease progression
|
1.7%
1/60 • Number of events 1 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
Other adverse events
| Measure |
Single Arm
n=60 participants at risk
single arm, open label study and Osimertinib 80 mg tablet was given orally once daily.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
4/60 • Number of events 4 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
5/60 • Number of events 6 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
4/60 • Number of events 4 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
General disorders
Fatigue
|
10.0%
6/60 • Number of events 7 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
General disorders
Decreased appetite
|
8.3%
5/60 • Number of events 5 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
General disorders
Mucosal inflammation
|
6.7%
4/60 • Number of events 4 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Infections and infestations
Paronychia
|
6.7%
4/60 • Number of events 5 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Investigations
Blood creatine phosphokinase increased
|
10.0%
6/60 • Number of events 7 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
4/60 • Number of events 4 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
5/60 • Number of events 5 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
4/60 • Number of events 7 • 6 months
An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The institution and/or investigator/Physician or Sponsor will provide a copy of any proposed publication or presentation for review and comment at least sixty (60) days prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER