Trial Outcomes & Findings for Phase I Trial of Afatinib (BIBW 2992) and Dasatinib in Non-small Cell Lung Cancer (NSCLC) (NCT NCT01999985)
NCT ID: NCT01999985
Last Updated: 2020-11-27
Results Overview
The MTD for this combined treatment will be defined as either: 1. The highest dosage cohort in which six patients had been treated and there were less than two dose limiting toxicities (DLTs) or, 2. Afatinib at the highest tolerated dose investigated (40 mg by mouth \[PO\] daily) plus dasatinib at the highest tolerated dose investigated (cohort 3, 140 mg PO daily).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Up to 6 Months
Results posted on
2020-11-27
Participant Flow
25 participants were enrolled at Moffitt Cancer Center from December 2013 to March 2016.
Participant milestones
| Measure |
Part 1A Level 1
Participants given 30 mg Afatinib and 100 mg Dasatinib
|
Part 1A Level 2
Participants given 40 mg Afatinib and 100 mg Dasatinib
|
Part 1B
Participants given Afatinib 30 mg and 100 mg Dasatinib
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
14
|
|
Overall Study
COMPLETED
|
8
|
3
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I Trial of Afatinib (BIBW 2992) and Dasatinib in Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
All Participants
n=25 Participants
All Participants Who Received Study Treatment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 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
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 MonthsPopulation: All participants who received at least one dose of Afatinib and Dasatinib.
The MTD for this combined treatment will be defined as either: 1. The highest dosage cohort in which six patients had been treated and there were less than two dose limiting toxicities (DLTs) or, 2. Afatinib at the highest tolerated dose investigated (40 mg by mouth \[PO\] daily) plus dasatinib at the highest tolerated dose investigated (cohort 3, 140 mg PO daily).
Outcome measures
| Measure |
Dose Escalation and Expansion
n=25 Participants
All Participants who received treatment.
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Afatinib (BIBW 2992) in Combination With Dasatinib
Afatinib
|
30 mg
|
|
Maximum Tolerated Dose (MTD) of Afatinib (BIBW 2992) in Combination With Dasatinib
Dasatinib daily
|
100 mg
|
SECONDARY outcome
Timeframe: Up to 6 MonthsPopulation: All Participants who received treatment.
Estimates objective response rate (complete response \[CR\] and partial response \[PR\]) in participants with acquired EGFR resistance
Outcome measures
| Measure |
Dose Escalation and Expansion
n=25 Participants
All Participants who received treatment.
|
|---|---|
|
Number of Participants With Objective Response
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 6 MonthsPopulation: All Participants who received treatment
Estimate the 6-month progression free survival (PFS) rate in participants with acquired EGFR resistance. Response Criteria for Phase 1B will follow RECIST v.1.1: Progressive Disease (PD) is defined as at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Dose Escalation and Expansion
n=25 Participants
All Participants who received treatment.
|
|---|---|
|
Median Progression Free Survival
|
5.5 months
Interval 2.6 to 8.5
|
Adverse Events
Part 1A Level 1
Serious events: 5 serious events
Other events: 8 other events
Deaths: 4 deaths
Part 1A Level 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 1B
Serious events: 9 serious events
Other events: 14 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part 1A Level 1
n=8 participants at risk
Participants were given 30 mg Afatinib and 100 mg Dasatinib
|
Part 1A Level 2
n=3 participants at risk
Participants were given 40 mg Afatinib and 100 mg Dasatinib
|
Part 1B
n=14 participants at risk
Participants given Afatinib 30 mg and 100 mg Dasatinib
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
14.3%
2/14 • Number of events 2 • 2 years, 5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/8 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Infections and infestations
Lung infection
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
21.4%
3/14 • Number of events 3 • 2 years, 5 months
|
|
Infections and infestations
Sepsis
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Investigations
Weight loss
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
14.3%
2/14 • Number of events 2 • 2 years, 5 months
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
14.3%
2/14 • Number of events 2 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory - Other
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
14.3%
2/14 • Number of events 2 • 2 years, 5 months
|
Other adverse events
| Measure |
Part 1A Level 1
n=8 participants at risk
Participants were given 30 mg Afatinib and 100 mg Dasatinib
|
Part 1A Level 2
n=3 participants at risk
Participants were given 40 mg Afatinib and 100 mg Dasatinib
|
Part 1B
n=14 participants at risk
Participants given Afatinib 30 mg and 100 mg Dasatinib
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
4/8 • Number of events 6 • 2 years, 5 months
|
100.0%
3/3 • Number of events 7 • 2 years, 5 months
|
35.7%
5/14 • Number of events 11 • 2 years, 5 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
28.6%
4/14 • Number of events 4 • 2 years, 5 months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Number of events 3 • 2 years, 5 months
|
66.7%
2/3 • Number of events 3 • 2 years, 5 months
|
14.3%
2/14 • Number of events 3 • 2 years, 5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
2/8 • Number of events 2 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
12.5%
1/8 • Number of events 2 • 2 years, 5 months
|
33.3%
1/3 • Number of events 4 • 2 years, 5 months
|
14.3%
2/14 • Number of events 2 • 2 years, 5 months
|
|
Gastrointestinal disorders
Mucositis oral
|
25.0%
2/8 • Number of events 2 • 2 years, 5 months
|
66.7%
2/3 • Number of events 2 • 2 years, 5 months
|
14.3%
2/14 • Number of events 3 • 2 years, 5 months
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
14.3%
2/14 • Number of events 2 • 2 years, 5 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 3 • 2 years, 5 months
|
66.7%
2/3 • Number of events 2 • 2 years, 5 months
|
42.9%
6/14 • Number of events 7 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
50.0%
4/8 • Number of events 4 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
35.7%
5/14 • Number of events 8 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8 • 2 years, 5 months
|
66.7%
2/3 • Number of events 3 • 2 years, 5 months
|
21.4%
3/14 • Number of events 4 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
25.0%
2/8 • Number of events 2 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
21.4%
3/14 • Number of events 3 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
28.6%
4/14 • Number of events 4 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
12.5%
1/8 • Number of events 3 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 4 • 2 years, 5 months
|
66.7%
2/3 • Number of events 2 • 2 years, 5 months
|
21.4%
3/14 • Number of events 3 • 2 years, 5 months
|
|
General disorders
Edema limbs
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
General disorders
General disorders and administration site conditions - Other
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
14.3%
2/14 • Number of events 3 • 2 years, 5 months
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
General disorders
Fever
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
14.3%
2/14 • Number of events 2 • 2 years, 5 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
14.3%
2/14 • Number of events 2 • 2 years, 5 months
|
|
General disorders
Edema face
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
37.5%
3/8 • Number of events 4 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
66.7%
2/3 • Number of events 3 • 2 years, 5 months
|
21.4%
3/14 • Number of events 4 • 2 years, 5 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
21.4%
3/14 • Number of events 3 • 2 years, 5 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Investigations
Creatinine increased
|
0.00%
0/8 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
14.3%
2/14 • Number of events 2 • 2 years, 5 months
|
|
Investigations
Weight loss
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
7.1%
1/14 • Number of events 2 • 2 years, 5 months
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Investigations
Investigations - Other
|
25.0%
2/8 • Number of events 2 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
1/8 • Number of events 2 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
42.9%
6/14 • Number of events 7 • 2 years, 5 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
14.3%
2/14 • Number of events 2 • 2 years, 5 months
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 2 • 2 years, 5 months
|
|
Infections and infestations
Bronchial infection
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Infections and infestations
Infections and infestations - Other
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/8 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Infections and infestations
Paronychia
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
2/8 • Number of events 2 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
21.4%
3/14 • Number of events 3 • 2 years, 5 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 2 • 2 years, 5 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
2/8 • Number of events 3 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
14.3%
2/14 • Number of events 2 • 2 years, 5 months
|
|
Cardiac disorders
Cardiac disorders - Other
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
21.4%
3/14 • Number of events 3 • 2 years, 5 months
|
|
Psychiatric disorders
Agitation
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Endocrine disorders
Endocrine disorders - Other
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Immune system disorders
Immune system disorders - Other
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Renal and urinary disorders
Urinary frequency
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Renal and urinary disorders
Urinary tract pain
|
12.5%
1/8 • Number of events 1 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Vascular disorders
Vascular disorders - Other
|
0.00%
0/8 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
7.1%
1/14 • Number of events 1 • 2 years, 5 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.00%
0/8 • 2 years, 5 months
|
33.3%
1/3 • Number of events 2 • 2 years, 5 months
|
0.00%
0/14 • 2 years, 5 months
|
Additional Information
Thoracic CRO, attn: Dr. Ben Creelan
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-3050
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place