Trial Outcomes & Findings for Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent (NCT NCT02568449)
NCT ID: NCT02568449
Last Updated: 2021-12-09
Results Overview
PFS will be estimated using standard Kaplan-Meier methods for censored data, from which the median and other statistics of interest will be calculated (e.g., rates at 3 months, 6 months, 12 months).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 4 months
Results posted on
2021-12-09
Participant Flow
Participant milestones
| Measure |
Treatment (Nintedanib)
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nintedanib in Treating Patients With Malignant Pleural Mesothelioma That Is Recurrent
Baseline characteristics by cohort
| Measure |
Treatment (Nintedanib)
n=20 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause; assessed up to 4 monthsPFS will be estimated using standard Kaplan-Meier methods for censored data, from which the median and other statistics of interest will be calculated (e.g., rates at 3 months, 6 months, 12 months).
Outcome measures
| Measure |
Treatment (Nintedanib)
n=20 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Progression-free Survival (PFS)
|
1.8 months
Interval 1.5 to 3.5
|
SECONDARY outcome
Timeframe: Up to 1 yearNumber of participants with grade 3 or grade 4 for each type of toxicity encountered, using all toxicity evaluable patients.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=20 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Incidence of Grade 3-4 Toxicity
Dyspnea (shortness of breath)
|
5 Participants
|
|
Incidence of Grade 3-4 Toxicity
Lymphopenia
|
4 Participants
|
|
Incidence of Grade 3-4 Toxicity
Hypoxia
|
2 Participants
|
|
Incidence of Grade 3-4 Toxicity
Syncope (fainting)
|
1 Participants
|
|
Incidence of Grade 3-4 Toxicity
pulmonary/upper respiratory- other, acute respiratory event
|
1 Participants
|
|
Incidence of Grade 3-4 Toxicity
Thrombosis/thrombus/embolism
|
1 Participants
|
|
Incidence of Grade 3-4 Toxicity
Encephalopathy
|
1 Participants
|
|
Incidence of Grade 3-4 Toxicity
Pericardial effusion
|
1 Participants
|
|
Incidence of Grade 3-4 Toxicity
Pain - Chest wall
|
1 Participants
|
|
Incidence of Grade 3-4 Toxicity
Ascites (non-malignant)
|
1 Participants
|
|
Incidence of Grade 3-4 Toxicity
Edema: trunk/genital
|
1 Participants
|
|
Incidence of Grade 3-4 Toxicity
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearOverall survival will be estimated using standard Kaplan-Meier methods for censored data, from which the median and other statistics of interest will be calculated (e.g., rates at 3 months, 6 months, 12 months).
Outcome measures
| Measure |
Treatment (Nintedanib)
n=20 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Overall Survival
|
4.1 months
Interval 2.5 to 8.7
|
SECONDARY outcome
Timeframe: Up to 1 yearnumber of participants responded (complete response, partial response, stable disease, progressive disease, not evaluable) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0)
Outcome measures
| Measure |
Treatment (Nintedanib)
n=20 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Number of Participants Responded (Complete Response, Partial Response, Stable Disease, Progressive Disease, Not Evaluable)
complete response
|
0 Participants
|
|
Number of Participants Responded (Complete Response, Partial Response, Stable Disease, Progressive Disease, Not Evaluable)
partial response
|
0 Participants
|
|
Number of Participants Responded (Complete Response, Partial Response, Stable Disease, Progressive Disease, Not Evaluable)
stable disease
|
0 Participants
|
|
Number of Participants Responded (Complete Response, Partial Response, Stable Disease, Progressive Disease, Not Evaluable)
progressive disease
|
18 Participants
|
|
Number of Participants Responded (Complete Response, Partial Response, Stable Disease, Progressive Disease, Not Evaluable)
not evaluable
|
2 Participants
|
Adverse Events
Treatment (Nintedanib)
Serious events: 12 serious events
Other events: 20 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Treatment (Nintedanib)
n=20 participants at risk
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
25.0%
5/20 • Number of events 5 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
20.0%
4/20 • Number of events 4 • Up to one year.
|
|
Nervous system disorders
Syncope (fainting)
|
5.0%
1/20 • Number of events 1 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary/upper respiratory- other, acute respiratory event
|
5.0%
1/20 • Number of events 1 • Up to one year.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
5.0%
1/20 • Number of events 1 • Up to one year.
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
5.0%
1/20 • Number of events 1 • Up to one year.
|
|
Nervous system disorders
Encephalopathy
|
5.0%
1/20 • Number of events 1 • Up to one year.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
5.0%
1/20 • Number of events 1 • Up to one year.
|
|
Cardiac disorders
Pericardial effusion
|
5.0%
1/20 • Number of events 1 • Up to one year.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • Up to one year.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.0%
1/20 • Number of events 1 • Up to one year.
|
Other adverse events
| Measure |
Treatment (Nintedanib)
n=20 participants at risk
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
ALT, SGPT
|
15.0%
3/20 • Number of events 3 • Up to one year.
|
|
Blood and lymphatic system disorders
AST, SGOT
|
30.0%
6/20 • Number of events 6 • Up to one year.
|
|
Blood and lymphatic system disorders
Albumin, serum-low (hypoalbuminemia)
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
6/20 • Number of events 6 • Up to one year.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
Blood and lymphatic system disorders
Calcium, serum-low (hypocalcemia)
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
6/20 • Number of events 6 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.0%
7/20 • Number of events 7 • Up to one year.
|
|
Blood and lymphatic system disorders
Creatinine
|
35.0%
7/20 • Number of events 7 • Up to one year.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
Gastrointestinal disorders
Diarrhea
|
85.0%
17/20 • Number of events 17 • Up to one year.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
15.0%
3/20 • Number of events 3 • Up to one year.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
85.0%
17/20 • Number of events 17 • Up to one year.
|
|
Blood and lymphatic system disorders
Edema: limb
|
35.0%
7/20 • Number of events 7 • Up to one year.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
65.0%
13/20 • Number of events 13 • Up to one year.
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
55.0%
11/20 • Number of events 11 • Up to one year.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
25.0%
5/20 • Number of events 5 • Up to one year.
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
15.0%
3/20 • Number of events 3 • Up to one year.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
20.0%
4/20 • Number of events 4 • Up to one year.
|
|
Blood and lymphatic system disorders
Magnesium, serum-low (hypomagnesemia)
|
15.0%
3/20 • Number of events 3 • Up to one year.
|
|
Nervous system disorders
Mood alteration - Anxiety
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
General disorders
Nausea
|
20.0%
4/20 • Number of events 4 • Up to one year.
|
|
General disorders
Pain - Abdomen NOS
|
35.0%
7/20 • Number of events 7 • Up to one year.
|
|
General disorders
Pain - Chest wall
|
30.0%
6/20 • Number of events 6 • Up to one year.
|
|
General disorders
Pain - Chest/thorax NOS
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
General disorders
Pain - Head/headache
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
General disorders
Pain - Other (Specify, __)
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
Blood and lymphatic system disorders
Platelets
|
15.0%
3/20 • Number of events 3 • Up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
Blood and lymphatic system disorders
Potassium, serum-high (hyperkalemia)
|
30.0%
6/20 • Number of events 6 • Up to one year.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
10.0%
2/20 • Number of events 2 • Up to one year.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Number of events 3 • Up to one year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place