Trial Outcomes & Findings for AZD2171 and Pemetrexed Disodium in Treating Patients With Relapsed Non-Small Cell Lung Cancer (NCT NCT00410904)
NCT ID: NCT00410904
Last Updated: 2018-04-13
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0) for target lesions and assessed by MRI or CT: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Overall Response (OR) = CR + PR, the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Up to 4 years
Results posted on
2018-04-13
Participant Flow
Cancer center clinic.
Participant milestones
| Measure |
Arm I Cohort A- No Prior Bevacizumab (Avastin)
Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm I Cohort B- Prior Bevacizumab (Avastin)
Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
|
Overall Study
COMPLETED
|
40
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AZD2171 and Pemetrexed Disodium in Treating Patients With Relapsed Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I Cohort A- No Prior Bevacizumab (Avastin)
n=40 Participants
Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm I Cohort B - Prior Bevacizumab (Avastin)
n=20 Participants
Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
FULL_RANGE 8.342 • n=5 Participants
|
58.5 years
FULL_RANGE 9.101 • n=7 Participants
|
59.5 years
FULL_RANGE 8.5683686 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
20 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 4 yearsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0) for target lesions and assessed by MRI or CT: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Overall Response (OR) = CR + PR, the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started)
Outcome measures
| Measure |
Arm I - Cohort A, no Prior Bevacizumab (Avastin)
n=40 Participants
Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm I - Cohort B, Prior Bevacizumab (Avastin)
n=20 Participants
Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Response Rate (Complete and Partial) 2 Separate Cohorts of Relapsed NSCLC Cohort A: Pts Who Have Received Prior Chemo w/o Ever Having Received Bevacizumab. Cohort B: Pts Who Have Received Prior Bevacizumab.
|
10 participants
|
4 participants
|
SECONDARY outcome
Timeframe: The duration of time from start of treatment to time of progression, assessed up to 4 yearsEstimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Arm I - Cohort A, no Prior Bevacizumab (Avastin)
n=60 Participants
Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm I - Cohort B, Prior Bevacizumab (Avastin)
Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival
|
5.6 months
Interval 4.1 to 6.8
|
—
|
SECONDARY outcome
Timeframe: The time from start of treatment to time of death, assessed up to 4 yearsEstimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates of all PFS and OS statistics will be calculated.
Outcome measures
| Measure |
Arm I - Cohort A, no Prior Bevacizumab (Avastin)
n=60 Participants
Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm I - Cohort B, Prior Bevacizumab (Avastin)
Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival
|
11.5 months
Interval 6.9 to 14.0
|
—
|
Adverse Events
Arm I - Cohort A
Serious events: 7 serious events
Other events: 33 other events
Deaths: 0 deaths
Arm I - Cohort B
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I - Cohort A
n=40 participants at risk
This is a one arm study with two cohorts.
Cohort A: No prior bevacizumab before entering into this trial
Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm I - Cohort B
n=20 participants at risk
This is a one arm study with two cohorts.
Cohort B: Prior bevacizumab before entering into this trial
Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Cardiac disorders
Atrial Flutter
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Cardiac disorders
Cardiac Arrest
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/40 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/40 • 30 days after the last dose of treatment
|
10.0%
2/20 • Number of events 2 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
2/40 • Number of events 2 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/40 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Pancreatitis
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
General disorders
Death NOS
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
General disorders
Fatigue
|
5.0%
2/40 • Number of events 2 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
General disorders
Fever
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Immune system disorders
Allergic reaction
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Immune system disorders
Anaphylaxis
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Infections and infestations
Lung infection
|
5.0%
2/40 • Number of events 2 • 30 days after the last dose of treatment
|
10.0%
2/20 • Number of events 2 • 30 days after the last dose of treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/40 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/40 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Investigations
Neutrophil count decreased
|
5.0%
2/40 • Number of events 2 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Investigations
Weight loss
|
0.00%
0/40 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Investigations
White blood cell decreased
|
5.0%
2/40 • Number of events 2 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
17.5%
7/40 • Number of events 7 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/40 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROGRESSION OF NSCLC
|
0.00%
0/40 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Nervous system disorders
CNS CEREBROVASCULAR ISCHEMIA
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Nervous system disorders
Seizure
|
5.0%
2/40 • Number of events 2 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Psychiatric disorders
Confusion
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Renal and urinary disorders
Proteinuria
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
5.0%
2/40 • Number of events 2 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
7.5%
3/40 • Number of events 3 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/40 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fistula
|
0.00%
0/40 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/40 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • Number of events 1 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Vascular disorders
Thromboembolic event
|
7.5%
3/40 • Number of events 3 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
Other adverse events
| Measure |
Arm I - Cohort A
n=40 participants at risk
This is a one arm study with two cohorts.
Cohort A: No prior bevacizumab before entering into this trial
Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
Arm I - Cohort B
n=20 participants at risk
This is a one arm study with two cohorts.
Cohort B: Prior bevacizumab before entering into this trial
Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
47.5%
19/40 • Number of events 19 • 30 days after the last dose of treatment
|
55.0%
11/20 • Number of events 11 • 30 days after the last dose of treatment
|
|
Endocrine disorders
Hypothyroidism
|
22.5%
9/40 • Number of events 9 • 30 days after the last dose of treatment
|
25.0%
5/20 • Number of events 5 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
ABDOMINAL CRAMPING
|
7.5%
3/40 • Number of events 3 • 30 days after the last dose of treatment
|
10.0%
2/20 • Number of events 2 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
7.5%
3/40 • Number of events 3 • 30 days after the last dose of treatment
|
15.0%
3/20 • Number of events 3 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
3/40 • Number of events 3 • 30 days after the last dose of treatment
|
20.0%
4/20 • Number of events 4 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Constipation
|
40.0%
16/40 • Number of events 16 • 30 days after the last dose of treatment
|
40.0%
8/20 • Number of events 8 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
70.0%
28/40 • Number of events 28 • 30 days after the last dose of treatment
|
80.0%
16/20 • Number of events 16 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
4/40 • Number of events 4 • 30 days after the last dose of treatment
|
10.0%
2/20 • Number of events 2 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
15.0%
6/40 • Number of events 6 • 30 days after the last dose of treatment
|
10.0%
2/20 • Number of events 2 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Nausea
|
55.0%
22/40 • Number of events 22 • 30 days after the last dose of treatment
|
50.0%
10/20 • Number of events 10 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Oral pain
|
10.0%
4/40 • Number of events 4 • 30 days after the last dose of treatment
|
10.0%
2/20 • Number of events 2 • 30 days after the last dose of treatment
|
|
Gastrointestinal disorders
Vomiting
|
27.5%
11/40 • Number of events 11 • 30 days after the last dose of treatment
|
30.0%
6/20 • Number of events 6 • 30 days after the last dose of treatment
|
|
General disorders
Edema limbs
|
12.5%
5/40 • Number of events 5 • 30 days after the last dose of treatment
|
20.0%
4/20 • Number of events 4 • 30 days after the last dose of treatment
|
|
General disorders
Fatigue
|
82.5%
33/40 • Number of events 33 • 30 days after the last dose of treatment
|
90.0%
18/20 • Number of events 18 • 30 days after the last dose of treatment
|
|
General disorders
Pain
|
7.5%
3/40 • Number of events 3 • 30 days after the last dose of treatment
|
25.0%
5/20 • Number of events 5 • 30 days after the last dose of treatment
|
|
Infections and infestations
Upper respiratory infection
|
17.5%
7/40 • Number of events 7 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Infections and infestations
Urinary tract infection
|
20.0%
8/40 • Number of events 8 • 30 days after the last dose of treatment
|
20.0%
4/20 • Number of events 4 • 30 days after the last dose of treatment
|
|
Investigations
Alanine aminotransferase increased
|
42.5%
17/40 • Number of events 17 • 30 days after the last dose of treatment
|
40.0%
8/20 • Number of events 8 • 30 days after the last dose of treatment
|
|
Investigations
Alkaline phosphatase increased
|
15.0%
6/40 • Number of events 6 • 30 days after the last dose of treatment
|
35.0%
7/20 • Number of events 7 • 30 days after the last dose of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
30.0%
12/40 • Number of events 12 • 30 days after the last dose of treatment
|
40.0%
8/20 • Number of events 8 • 30 days after the last dose of treatment
|
|
Investigations
Creatinine increased
|
27.5%
11/40 • Number of events 11 • 30 days after the last dose of treatment
|
15.0%
3/20 • Number of events 3 • 30 days after the last dose of treatment
|
|
Investigations
INCREASED BUN
|
5.0%
2/40 • Number of events 2 • 30 days after the last dose of treatment
|
15.0%
3/20 • Number of events 3 • 30 days after the last dose of treatment
|
|
Investigations
Lymphocyte count decreased
|
17.5%
7/40 • Number of events 7 • 30 days after the last dose of treatment
|
10.0%
2/20 • Number of events 2 • 30 days after the last dose of treatment
|
|
Investigations
Neutrophil count decreased
|
30.0%
12/40 • Number of events 12 • 30 days after the last dose of treatment
|
55.0%
11/20 • Number of events 11 • 30 days after the last dose of treatment
|
|
Investigations
Platelet count decreased
|
50.0%
20/40 • Number of events 20 • 30 days after the last dose of treatment
|
50.0%
10/20 • Number of events 10 • 30 days after the last dose of treatment
|
|
Investigations
Weight loss
|
22.5%
9/40 • Number of events 9 • 30 days after the last dose of treatment
|
40.0%
8/20 • Number of events 8 • 30 days after the last dose of treatment
|
|
Investigations
White blood cell decreased
|
55.0%
22/40 • Number of events 22 • 30 days after the last dose of treatment
|
60.0%
12/20 • Number of events 12 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
67.5%
27/40 • Number of events 27 • 30 days after the last dose of treatment
|
75.0%
15/20 • Number of events 15 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
8/40 • Number of events 8 • 30 days after the last dose of treatment
|
15.0%
3/20 • Number of events 3 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
72.5%
29/40 • Number of events 29 • 30 days after the last dose of treatment
|
100.0%
20/20 • Number of events 20 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
5/40 • Number of events 5 • 30 days after the last dose of treatment
|
10.0%
2/20 • Number of events 2 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
42.5%
17/40 • Number of events 17 • 30 days after the last dose of treatment
|
50.0%
10/20 • Number of events 10 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.0%
6/40 • Number of events 6 • 30 days after the last dose of treatment
|
10.0%
2/20 • Number of events 2 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.5%
3/40 • Number of events 3 • 30 days after the last dose of treatment
|
10.0%
2/20 • Number of events 2 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.5%
9/40 • Number of events 9 • 30 days after the last dose of treatment
|
30.0%
6/20 • Number of events 6 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.0%
6/40 • Number of events 6 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.0%
12/40 • Number of events 12 • 30 days after the last dose of treatment
|
40.0%
8/20 • Number of events 8 • 30 days after the last dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
6/40 • Number of events 6 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
15.0%
6/40 • Number of events 6 • 30 days after the last dose of treatment
|
20.0%
4/20 • Number of events 4 • 30 days after the last dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
4/40 • Number of events 4 • 30 days after the last dose of treatment
|
10.0%
2/20 • Number of events 2 • 30 days after the last dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
4/40 • Number of events 4 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Nervous system disorders
Dizziness
|
20.0%
8/40 • Number of events 8 • 30 days after the last dose of treatment
|
15.0%
3/20 • Number of events 3 • 30 days after the last dose of treatment
|
|
Nervous system disorders
Dysgeusia
|
12.5%
5/40 • Number of events 5 • 30 days after the last dose of treatment
|
15.0%
3/20 • Number of events 3 • 30 days after the last dose of treatment
|
|
Nervous system disorders
Headache
|
15.0%
6/40 • Number of events 6 • 30 days after the last dose of treatment
|
15.0%
3/20 • Number of events 3 • 30 days after the last dose of treatment
|
|
Psychiatric disorders
Anxiety
|
7.5%
3/40 • Number of events 3 • 30 days after the last dose of treatment
|
5.0%
1/20 • Number of events 1 • 30 days after the last dose of treatment
|
|
Psychiatric disorders
Insomnia
|
10.0%
4/40 • Number of events 4 • 30 days after the last dose of treatment
|
15.0%
3/20 • Number of events 3 • 30 days after the last dose of treatment
|
|
Renal and urinary disorders
Hematuria
|
7.5%
3/40 • Number of events 3 • 30 days after the last dose of treatment
|
15.0%
3/20 • Number of events 3 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.0%
4/40 • Number of events 4 • 30 days after the last dose of treatment
|
10.0%
2/20 • Number of events 2 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
47.5%
19/40 • Number of events 19 • 30 days after the last dose of treatment
|
35.0%
7/20 • Number of events 7 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
10/40 • Number of events 10 • 30 days after the last dose of treatment
|
30.0%
6/20 • Number of events 6 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
4/40 • Number of events 4 • 30 days after the last dose of treatment
|
10.0%
2/20 • Number of events 2 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
22.5%
9/40 • Number of events 9 • 30 days after the last dose of treatment
|
25.0%
5/20 • Number of events 5 • 30 days after the last dose of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
5/40 • Number of events 5 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Vascular disorders
Hypertension
|
52.5%
21/40 • Number of events 21 • 30 days after the last dose of treatment
|
55.0%
11/20 • Number of events 11 • 30 days after the last dose of treatment
|
|
Psychiatric disorders
Depression
|
7.5%
3/40 • Number of events 3 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.5%
3/40 • Number of events 3 • 30 days after the last dose of treatment
|
0.00%
0/20 • 30 days after the last dose of treatment
|
Additional Information
Shirish M. Gadgeel, M.D.
Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8753
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60