Trial Outcomes & Findings for Nintedanib in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Up to Two Previous Chemotherapy Regimens (NCT NCT01948141)
NCT ID: NCT01948141
Last Updated: 2017-06-08
Results Overview
The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
COMPLETED
PHASE2
6 participants
At 6 months
2017-06-08
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
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nintedanib in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Up to Two Previous Chemotherapy Regimens
Baseline characteristics by cohort
| Measure |
Treatment (Nintedanib)
n=6 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
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 5.3 • n=39 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: All patients in FGFR1 amplified group
The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=2 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
|
|---|---|
|
6-month Progression Free Survival (PFS) Rate Within the Entire FGFR1 Amplified Group
|
0 percentage of participants
Interval 0.0 to 65.8
|
SECONDARY outcome
Timeframe: Time from study entry to the first of either disease progression or death, assessed at 6 monthsPopulation: All treated and eligible patients. One participant was not done due to not enough tissue.
The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=5 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
|
|---|---|
|
Compare the 6-month PFS Rate for the Entire FGFR1 Amplified Group Versus the FGFR1 Non-amplified Patients.
Amplified
|
0 percentage of participants
|
|
Compare the 6-month PFS Rate for the Entire FGFR1 Amplified Group Versus the FGFR1 Non-amplified Patients.
Non-amplified
|
0 percentage of participants
|
|
Compare the 6-month PFS Rate for the Entire FGFR1 Amplified Group Versus the FGFR1 Non-amplified Patients.
Total
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Time from study entry to the first of either disease progression or death, assessed at 6 monthsPopulation: All treated and eligible patients. One participant was not done due to not enough tissue.
The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=5 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
|
|---|---|
|
Compare the 6-month PFS Rate for Each FGFR1 Amplified Group (Low, Intermediate, and High) Versus FGFR1 Non-amplified Patients.
Non-amplified
|
0 percentage of participants
|
|
Compare the 6-month PFS Rate for Each FGFR1 Amplified Group (Low, Intermediate, and High) Versus FGFR1 Non-amplified Patients.
Intermediate amplification
|
0 percentage of participants
|
|
Compare the 6-month PFS Rate for Each FGFR1 Amplified Group (Low, Intermediate, and High) Versus FGFR1 Non-amplified Patients.
High amplificiation
|
0 percentage of participants
|
|
Compare the 6-month PFS Rate for Each FGFR1 Amplified Group (Low, Intermediate, and High) Versus FGFR1 Non-amplified Patients.
Total
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Time from study entry to the first of either disease progression or death, assessed at 6 monthsPopulation: No comparison was done do versus historical controls because it was inappropriate due to the small number of patients available.
The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From study entry to death from any cause, assessed up to 3 yearsOverall survival (OS) was defined as the time from study entry to death from any cause.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=6 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 (OS)
Amplified
|
10.2 months
Interval 4.0 to 16.4
|
|
Overall Survival (OS)
Non-amplified
|
5.8 months
Interval 4.6 to 23.7
|
|
Overall Survival (OS)
Overall
|
10.6 months
Interval 4.0 to 23.7
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All treated and eligible patients. No statistics computed due to all patients were non-response in both groups.
Tumor Response rate was defined as the proportion of patients who had Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria. Complete Response (CR): Disappearance of all target lesions. Any lymph nodes must have a reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=6 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
|
|---|---|
|
Tumor Response Rate
Amplified
|
0 percentage of participants
Interval 0.0 to 66.0
|
|
Tumor Response Rate
Non-amplified
|
0 percentage of participants
Interval 0.0 to 56.0
|
|
Tumor Response Rate
Total
|
0 percentage of participants
Interval 0.0 to 39.0
|
SECONDARY outcome
Timeframe: Up to 30 days post-treatmentPopulation: All treated and eligible patients. No statistics computed due to all patients had AEs in both groups.
Percentage of participants with adverse events. Incidence of Adverse Events (AEs) was Accessed by the National Cancer Institute (NCI) CTCAE Version 4.0.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=6 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 Adverse Events (AEs)
Total
|
100 percentage of participants
Interval 61.0 to 100.0
|
|
Incidence of Adverse Events (AEs)
Amplified
|
100 percentage of participants
Interval 34.0 to 100.0
|
|
Incidence of Adverse Events (AEs)
Non-amplified
|
100 percentage of participants
Interval 44.0 to 100.0
|
SECONDARY outcome
Timeframe: Time from study entry to the first of either disease progression or death, assessed up to 3 yearsPopulation: All treated patients
Progression-free survival (PFS) was defined as the time from study entry to the first of either disease progression or death.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=6 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
Overall
|
2.7 months
Interval 1.7 to 15.1
|
|
Progression Free Survival
Amplified
|
1.8 months
Interval 1.8 to 1.9
|
|
Progression Free Survival
Non-amplified
|
3.4 months
Interval 1.7 to 5.4
|
Adverse Events
Treatment (Nintedanib)
Serious adverse events
| Measure |
Treatment (Nintedanib)
n=6 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
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Infections and infestations
Septic shock
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Nintedanib)
n=6 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
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Cardiac disorders
Cardiac disorder
|
33.3%
2/6 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Number of events 8
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
16.7%
1/6 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 3
|
|
General disorders
Fatigue
|
66.7%
4/6 • Number of events 5
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
2/6 • Number of events 4
|
|
Investigations
Blood alkaline phosphatase increased
|
50.0%
3/6 • Number of events 5
|
|
Investigations
Gamma-glutamyltransferase increased
|
33.3%
2/6 • Number of events 4
|
|
Investigations
Lymphocyte count increased
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Weight decreased
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 3
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
3/6 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Number of events 9
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place