Trial Outcomes & Findings for Nintedanib in Patients With Advanced Esophagogastric Cancer (NCT NCT02234596)
NCT ID: NCT02234596
Last Updated: 2021-01-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
6 months
Results posted on
2021-01-25
Participant Flow
Participant milestones
| Measure |
Nintedanib
Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Nintedanib
Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
|
|---|---|
|
Overall Study
Participant not treated
|
2
|
Baseline Characteristics
Nintedanib in Patients With Advanced Esophagogastric Cancer
Baseline characteristics by cohort
| Measure |
Nintedanib
n=34 Participants
Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
|
|---|---|
|
Age, Customized
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Nintedanib
n=32 Participants
Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
|
|---|---|
|
6-month Progression-free Survival (PFS)
|
1.9 months
Interval 1.6 to 3.6
|
SECONDARY outcome
Timeframe: 3 yearsdefined as both complete response (CR) and partial response (PR), as measured by RECIST response criteria.
Outcome measures
| Measure |
Nintedanib
n=32 Participants
Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
|
|---|---|
|
Objective Response Rate
Complete Response
|
0 Participants
|
|
Objective Response Rate
Partial Response
|
0 Participants
|
|
Objective Response Rate
Stable Disease
|
14 Participants
|
|
Objective Response Rate
Progressive Disease
|
18 Participants
|
SECONDARY outcome
Timeframe: 3 yearsThe severity of adverse event should be classified and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Outcome measures
| Measure |
Nintedanib
n=32 Participants
Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
|
|---|---|
|
Participants Evaluated for Toxicities
|
32 Participants
|
Adverse Events
Nintedanib
Serious events: 8 serious events
Other events: 32 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Nintedanib
n=34 participants at risk
Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.9%
1/34 • 3 years
|
|
Cardiac disorders
Heart Failure
|
2.9%
1/34 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/34 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • 3 years
|
|
General disorders
Death NOS
|
8.8%
3/34 • 3 years
|
|
General disorders
Fatigue
|
5.9%
2/34 • 3 years
|
|
General disorders
Fever
|
2.9%
1/34 • 3 years
|
|
Infections and infestations
Skin infection
|
2.9%
1/34 • 3 years
|
|
Investigations
Blood bilirubin increased
|
2.9%
1/34 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
1/34 • 3 years
|
|
Nervous system disorders
Dizziness
|
2.9%
1/34 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
2/34 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/34 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders, Other, spec
|
2.9%
1/34 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
2.9%
1/34 • 3 years
|
Other adverse events
| Measure |
Nintedanib
n=34 participants at risk
Nintedanib: Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
|
|---|---|
|
General disorders
Fatigue
|
52.9%
18/34 • 3 years
|
|
Vascular disorders
Hypertension
|
47.1%
16/34 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
41.2%
14/34 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
38.2%
13/34 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
35.3%
12/34 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
32.4%
11/34 • 3 years
|
|
Investigations
Alkaline phosphatase increased
|
32.4%
11/34 • 3 years
|
|
Investigations
Platelet count decreased
|
14.7%
5/34 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
11.8%
4/34 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
4/34 • 3 years
|
|
Investigations
White blood cell decreased
|
11.8%
4/34 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
8.8%
3/34 • 3 years
|
|
Investigations
Blood bilirubin increased
|
8.8%
3/34 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.8%
3/34 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
8.8%
3/34 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
5.9%
2/34 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
2/34 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
2/34 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
5.9%
2/34 • 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
5.9%
2/34 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
2/34 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
2/34 • 3 years
|
Additional Information
Dr. Yelena Janjigian,
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place