Trial Outcomes & Findings for Pemetrexed Disodium With or Without Sorafenib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NCT NCT00454194)
NCT ID: NCT00454194
Last Updated: 2017-03-21
Results Overview
The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Time from randomization to the disease progression or death (up to 5 years)
Results posted on
2017-03-21
Participant Flow
One-hundred and ten (110) participants were enrolled between October 2007 and April 2010.
Twelve participants were excluded from all analyses due to five participants had squamous-cell histology, 1 never received treatment and 1 withdrew consent in pemetrexed+sorafenib group; and three participants had squamous-cell histology and 2 never received treatment in pemetrexed alone group.
Participant milestones
| Measure |
Arm I (Pemetrexed + Sorafenib)
Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
|
Arm II (Pemetrexed)
Patients receive pemetrexed disodium IV over 10 minutes on day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
51
|
|
Overall Study
COMPLETED
|
25
|
37
|
|
Overall Study
NOT COMPLETED
|
22
|
14
|
Reasons for withdrawal
| Measure |
Arm I (Pemetrexed + Sorafenib)
Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
|
Arm II (Pemetrexed)
Patients receive pemetrexed disodium IV over 10 minutes on day 1.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
2
|
|
Overall Study
Withdrawal by Subject
|
12
|
8
|
|
Overall Study
Other Medical Problems
|
1
|
2
|
|
Overall Study
Other Unspecified Reason
|
2
|
2
|
Baseline Characteristics
Pemetrexed Disodium With or Without Sorafenib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Pemetrexed + Sorafenib)
n=47 Participants
Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
|
Arm II (Pemetrexed)
n=51 Participants
Patients receive pemetrexed disodium IV over 10 minutes on day 1.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
62 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0=Asymptomatic and fully active
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1=Symptomatic and fully ambulatory
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Stage
IIIB
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Stage
IV
|
39 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Prior Bevacizumab
Yes
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Prior Bevacizumab
No
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Histology
Bronchioloalveolar Carcinoma
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Histology
Non-small cell lung cancer,not otherwise specified
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Histology
Large Cell
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Histology
Large Cell Neuroendocrine
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to the disease progression or death (up to 5 years)Population: All participants who met the eligibility criteria and started the treatment.
The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), 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 (Pemetrexed + Sorafenib)
n=47 Participants
Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
|
Arm II (Pemetrexed)
n=51 Participants
Patients receive pemetrexed disodium IV over 10 minutes on day 1.
|
|---|---|---|
|
Progression-free Survival
|
3.4 months
Interval 2.6 to 5.7
|
4.1 months
Interval 1.6 to 5.7
|
SECONDARY outcome
Timeframe: Time from randomization to death or last follow-up (up to 5 years)Population: All participants who met the eligibility criteria and started the treatment.
Overall survival was defined as the time from study enrollment (randomization) to the time of death from any cause or last follow-up.
Outcome measures
| Measure |
Arm I (Pemetrexed + Sorafenib)
n=47 Participants
Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
|
Arm II (Pemetrexed)
n=51 Participants
Patients receive pemetrexed disodium IV over 10 minutes on day 1.
|
|---|---|---|
|
Overall Survival
|
9.3 months
Interval 5.9 to 12.2
|
10.4 months
Interval 7.2 to 13.5
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All participants who met the eligibility criteria and ended the treatment.
Time to treatment failure was defined as the time from date of randomization to the date at which the patient was removed from the treatment due to progression, toxicity, refusal or other medical problems.
Outcome measures
| Measure |
Arm I (Pemetrexed + Sorafenib)
n=47 Participants
Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
|
Arm II (Pemetrexed)
n=50 Participants
Patients receive pemetrexed disodium IV over 10 minutes on day 1.
|
|---|---|---|
|
Time to Treatment Failure
|
2.0 months
Interval 1.5 to 3.1
|
3.1 months
Interval 1.6 to 5.3
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All participants who met the eligibility criteria, have started the study treatment and had confirmed CR or PR.
Duration of response was defined as the time from the date at which the patient's earliest best objective status was first noted to be either a complete response (CR) or partial response (PR) to the earliest date progression was documented. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Complete Response (CR): disappearance of all target lesions; * Partial Response (PR) 30% decrease in sum of longest diameter of target lesions;
Outcome measures
| Measure |
Arm I (Pemetrexed + Sorafenib)
n=6 Participants
Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
|
Arm II (Pemetrexed)
n=5 Participants
Patients receive pemetrexed disodium IV over 10 minutes on day 1.
|
|---|---|---|
|
Duration of Response
|
7.4 months
Interval 4.1 to 21.4
|
8.5 months
Interval 4.7 to 14.4
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: All participants who met the eligibility criteria and started the treatment.
Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. The maximum grade for each type of adverse events were recorded for each patient.
Outcome measures
| Measure |
Arm I (Pemetrexed + Sorafenib)
n=47 Participants
Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
|
Arm II (Pemetrexed)
n=51 Participants
Patients receive pemetrexed disodium IV over 10 minutes on day 1.
|
|---|---|---|
|
Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0
|
43 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All participants who met the eligibility criteria and started the treatment.
A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: * Complete Response (CR): disappearance of all target lesions; * Partial Response (PR) 30% decrease in sum of longest diameter of target lesions; * Progressive Disease (PD): 20% increase in sum of longest diameter of target lesions; * Stable Disease (SD): small changes that do not meet above criteria.
Outcome measures
| Measure |
Arm I (Pemetrexed + Sorafenib)
n=47 Participants
Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
|
Arm II (Pemetrexed)
n=51 Participants
Patients receive pemetrexed disodium IV over 10 minutes on day 1.
|
|---|---|---|
|
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Confirmed Response (Partial Response)
|
12.8 percentage of participants
|
9.8 percentage of participants
|
|
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Progression
|
23.4 percentage of participants
|
35.3 percentage of participants
|
|
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Not Assessed
|
25.5 percentage of participants
|
9.8 percentage of participants
|
|
Confirmed Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Stable Disease
|
38.3 percentage of participants
|
45.1 percentage of participants
|
Adverse Events
Arm I (Pemetrexed + Sorafenib)
Serious events: 13 serious events
Other events: 47 other events
Deaths: 0 deaths
Arm II (Pemetrexed)
Serious events: 7 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Pemetrexed + Sorafenib)
n=47 participants at risk
Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
|
Arm II (Pemetrexed)
n=51 participants at risk
Patients receive pemetrexed disodium IV over 10 minutes on day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
3.9%
2/51 • Number of events 2 • Up to 2.6 years
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
2/47 • Number of events 2 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Gastrointestinal disorders
Small intestinal perforation
|
2.1%
1/47 • Number of events 2 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
General disorders
Fatigue
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
General disorders
Sudden death
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Investigations
Aspartate aminotransferase increased
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Investigations
Bilirubin increased
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Investigations
Leukocyte count decreased
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Investigations
Lipase increased
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Investigations
Neutrophil count decreased
|
8.5%
4/47 • Number of events 4 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Investigations
Platelet count decreased
|
6.4%
3/47 • Number of events 3 • Up to 2.6 years
|
3.9%
2/51 • Number of events 2 • Up to 2.6 years
|
|
Investigations
Weight loss
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Nervous system disorders
Headache
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Nervous system disorders
Ischemia cerebrovascular
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hemorrhage
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/47 • Up to 2.6 years
|
3.9%
2/51 • Number of events 2 • Up to 2.6 years
|
|
Vascular disorders
Thrombosis
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
Other adverse events
| Measure |
Arm I (Pemetrexed + Sorafenib)
n=47 participants at risk
Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
|
Arm II (Pemetrexed)
n=51 participants at risk
Patients receive pemetrexed disodium IV over 10 minutes on day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
89.4%
42/47 • Number of events 208 • Up to 2.6 years
|
82.4%
42/51 • Number of events 218 • Up to 2.6 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Blood and lymphatic system disorders
Lymphatic disorder
|
2.1%
1/47 • Number of events 6 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Cardiac disorders
Cardiac pain
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 5 • Up to 2.6 years
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 5 • Up to 2.6 years
|
|
Endocrine disorders
Hyperthyroidism
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Eye disorders
Dry eye syndrome
|
2.1%
1/47 • Number of events 6 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Eye disorders
Vision blurred
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 2 • Up to 2.6 years
|
|
Eye disorders
Watering eyes
|
6.4%
3/47 • Number of events 8 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Gastrointestinal disorders
Abdominal pain
|
40.4%
19/47 • Number of events 33 • Up to 2.6 years
|
29.4%
15/51 • Number of events 28 • Up to 2.6 years
|
|
Gastrointestinal disorders
Constipation
|
14.9%
7/47 • Number of events 10 • Up to 2.6 years
|
3.9%
2/51 • Number of events 5 • Up to 2.6 years
|
|
Gastrointestinal disorders
Diarrhea
|
48.9%
23/47 • Number of events 68 • Up to 2.6 years
|
27.5%
14/51 • Number of events 19 • Up to 2.6 years
|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
2/47 • Number of events 13 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
2/47 • Number of events 2 • Up to 2.6 years
|
2.0%
1/51 • Number of events 2 • Up to 2.6 years
|
|
Gastrointestinal disorders
Dysphagia
|
4.3%
2/47 • Number of events 2 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
29.8%
14/47 • Number of events 27 • Up to 2.6 years
|
5.9%
3/51 • Number of events 5 • Up to 2.6 years
|
|
Gastrointestinal disorders
Flatulence
|
4.3%
2/47 • Number of events 4 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Gastrointestinal disorders
Mucositis oral
|
42.6%
20/47 • Number of events 42 • Up to 2.6 years
|
15.7%
8/51 • Number of events 12 • Up to 2.6 years
|
|
Gastrointestinal disorders
Nausea
|
66.0%
31/47 • Number of events 87 • Up to 2.6 years
|
47.1%
24/51 • Number of events 83 • Up to 2.6 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Gastrointestinal disorders
Vomiting
|
38.3%
18/47 • Number of events 44 • Up to 2.6 years
|
23.5%
12/51 • Number of events 28 • Up to 2.6 years
|
|
General disorders
Chest pain
|
6.4%
3/47 • Number of events 4 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
General disorders
Chills
|
6.4%
3/47 • Number of events 3 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
General disorders
Death
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
General disorders
Disease progression
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
3.9%
2/51 • Number of events 2 • Up to 2.6 years
|
|
General disorders
Edema limbs
|
2.1%
1/47 • Number of events 2 • Up to 2.6 years
|
3.9%
2/51 • Number of events 7 • Up to 2.6 years
|
|
General disorders
Fatigue
|
97.9%
46/47 • Number of events 246 • Up to 2.6 years
|
94.1%
48/51 • Number of events 228 • Up to 2.6 years
|
|
General disorders
Fever
|
19.1%
9/47 • Number of events 12 • Up to 2.6 years
|
11.8%
6/51 • Number of events 8 • Up to 2.6 years
|
|
General disorders
Flu-like symptoms
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
General disorders
Localized edema
|
4.3%
2/47 • Number of events 4 • Up to 2.6 years
|
3.9%
2/51 • Number of events 2 • Up to 2.6 years
|
|
General disorders
Pain
|
4.3%
2/47 • Number of events 2 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Hepatobiliary disorders
Cholecystitis
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Hepatobiliary disorders
Hepatic failure
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Immune system disorders
Hypersensitivity
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Infections and infestations
Abdominal infection
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Infections and infestations
Bladder infection
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Infections and infestations
Bronchitis
|
6.4%
3/47 • Number of events 3 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Infections and infestations
Gingival infection
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Infections and infestations
Infection
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Infections and infestations
Pneumonia
|
6.4%
3/47 • Number of events 3 • Up to 2.6 years
|
5.9%
3/51 • Number of events 5 • Up to 2.6 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/47 • Up to 2.6 years
|
3.9%
2/51 • Number of events 2 • Up to 2.6 years
|
|
Infections and infestations
Skin infection
|
4.3%
2/47 • Number of events 3 • Up to 2.6 years
|
2.0%
1/51 • Number of events 3 • Up to 2.6 years
|
|
Infections and infestations
Upper respiratory infection
|
4.3%
2/47 • Number of events 2 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/47 • Number of events 2 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Investigations
Alanine aminotransferase increased
|
14.9%
7/47 • Number of events 22 • Up to 2.6 years
|
5.9%
3/51 • Number of events 4 • Up to 2.6 years
|
|
Investigations
Alkaline phosphatase increased
|
14.9%
7/47 • Number of events 18 • Up to 2.6 years
|
3.9%
2/51 • Number of events 5 • Up to 2.6 years
|
|
Investigations
Aspartate aminotransferase increased
|
12.8%
6/47 • Number of events 48 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Investigations
Cardiac troponin I increased
|
6.4%
3/47 • Number of events 3 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Investigations
Creatinine increased
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
3.9%
2/51 • Number of events 3 • Up to 2.6 years
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Investigations
Leukocyte count decreased
|
61.7%
29/47 • Number of events 87 • Up to 2.6 years
|
35.3%
18/51 • Number of events 41 • Up to 2.6 years
|
|
Investigations
Lipase increased
|
8.5%
4/47 • Number of events 9 • Up to 2.6 years
|
11.8%
6/51 • Number of events 8 • Up to 2.6 years
|
|
Investigations
Lymphocyte count decreased
|
17.0%
8/47 • Number of events 39 • Up to 2.6 years
|
5.9%
3/51 • Number of events 19 • Up to 2.6 years
|
|
Investigations
Neutrophil count decreased
|
44.7%
21/47 • Number of events 40 • Up to 2.6 years
|
23.5%
12/51 • Number of events 23 • Up to 2.6 years
|
|
Investigations
Platelet count decreased
|
42.6%
20/47 • Number of events 52 • Up to 2.6 years
|
27.5%
14/51 • Number of events 20 • Up to 2.6 years
|
|
Investigations
Weight gain
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Investigations
Weight loss
|
44.7%
21/47 • Number of events 46 • Up to 2.6 years
|
27.5%
14/51 • Number of events 50 • Up to 2.6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
59.6%
28/47 • Number of events 70 • Up to 2.6 years
|
49.0%
25/51 • Number of events 61 • Up to 2.6 years
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
21.3%
10/47 • Number of events 21 • Up to 2.6 years
|
15.7%
8/51 • Number of events 45 • Up to 2.6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
10.6%
5/47 • Number of events 6 • Up to 2.6 years
|
5.9%
3/51 • Number of events 3 • Up to 2.6 years
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
8.5%
4/47 • Number of events 5 • Up to 2.6 years
|
7.8%
4/51 • Number of events 12 • Up to 2.6 years
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
8.5%
4/47 • Number of events 5 • Up to 2.6 years
|
2.0%
1/51 • Number of events 3 • Up to 2.6 years
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
6.4%
3/47 • Number of events 4 • Up to 2.6 years
|
5.9%
3/51 • Number of events 4 • Up to 2.6 years
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
36.2%
17/47 • Number of events 37 • Up to 2.6 years
|
21.6%
11/51 • Number of events 33 • Up to 2.6 years
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
8.5%
4/47 • Number of events 6 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
12.8%
6/47 • Number of events 19 • Up to 2.6 years
|
9.8%
5/51 • Number of events 7 • Up to 2.6 years
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
3/47 • Number of events 4 • Up to 2.6 years
|
3.9%
2/51 • Number of events 6 • Up to 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/47 • Up to 2.6 years
|
5.9%
3/51 • Number of events 3 • Up to 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
2.0%
1/51 • Number of events 3 • Up to 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
8.5%
4/47 • Number of events 5 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 3 • Up to 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 2 • Up to 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
2/47 • Number of events 4 • Up to 2.6 years
|
3.9%
2/51 • Number of events 4 • Up to 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.8%
6/47 • Number of events 8 • Up to 2.6 years
|
3.9%
2/51 • Number of events 2 • Up to 2.6 years
|
|
Nervous system disorders
Depressed level of consciousness
|
8.5%
4/47 • Number of events 4 • Up to 2.6 years
|
2.0%
1/51 • Number of events 3 • Up to 2.6 years
|
|
Nervous system disorders
Dizziness
|
4.3%
2/47 • Number of events 2 • Up to 2.6 years
|
2.0%
1/51 • Number of events 2 • Up to 2.6 years
|
|
Nervous system disorders
Headache
|
10.6%
5/47 • Number of events 5 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
53.2%
25/47 • Number of events 96 • Up to 2.6 years
|
45.1%
23/51 • Number of events 117 • Up to 2.6 years
|
|
Nervous system disorders
Seizure
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Nervous system disorders
Speech disorder
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Nervous system disorders
Taste alteration
|
12.8%
6/47 • Number of events 9 • Up to 2.6 years
|
2.0%
1/51 • Number of events 11 • Up to 2.6 years
|
|
Psychiatric disorders
Anxiety
|
6.4%
3/47 • Number of events 3 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Psychiatric disorders
Confusion
|
4.3%
2/47 • Number of events 2 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Psychiatric disorders
Insomnia
|
4.3%
2/47 • Number of events 2 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Renal and urinary disorders
Protein urine positive
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Renal and urinary disorders
Urinary frequency
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.3%
2/47 • Number of events 5 • Up to 2.6 years
|
3.9%
2/51 • Number of events 2 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hemorrhage
|
6.4%
3/47 • Number of events 3 • Up to 2.6 years
|
5.9%
3/51 • Number of events 3 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.8%
6/47 • Number of events 24 • Up to 2.6 years
|
13.7%
7/51 • Number of events 20 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.4%
11/47 • Number of events 24 • Up to 2.6 years
|
21.6%
11/51 • Number of events 21 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
10.6%
5/47 • Number of events 7 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.3%
2/47 • Number of events 2 • Up to 2.6 years
|
9.8%
5/51 • Number of events 6 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
6.4%
3/47 • Number of events 3 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
17.0%
8/47 • Number of events 11 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
0.00%
0/47 • Up to 2.6 years
|
3.9%
2/51 • Number of events 3 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 2 • Up to 2.6 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
12.8%
6/47 • Number of events 7 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.6%
5/47 • Number of events 5 • Up to 2.6 years
|
3.9%
2/51 • Number of events 12 • Up to 2.6 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.8%
6/47 • Number of events 19 • Up to 2.6 years
|
2.0%
1/51 • Number of events 3 • Up to 2.6 years
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
48.9%
23/47 • Number of events 72 • Up to 2.6 years
|
2.0%
1/51 • Number of events 3 • Up to 2.6 years
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
4.3%
2/47 • Number of events 5 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.1%
1/47 • Number of events 4 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
29.8%
14/47 • Number of events 19 • Up to 2.6 years
|
7.8%
4/51 • Number of events 6 • Up to 2.6 years
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
44.7%
21/47 • Number of events 33 • Up to 2.6 years
|
7.8%
4/51 • Number of events 6 • Up to 2.6 years
|
|
Skin and subcutaneous tissue disorders
Sweating
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Vascular disorders
Hot flashes
|
2.1%
1/47 • Number of events 2 • Up to 2.6 years
|
0.00%
0/51 • Up to 2.6 years
|
|
Vascular disorders
Hypertension
|
40.4%
19/47 • Number of events 56 • Up to 2.6 years
|
21.6%
11/51 • Number of events 29 • Up to 2.6 years
|
|
Vascular disorders
Hypotension
|
2.1%
1/47 • Number of events 1 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
|
Vascular disorders
Thrombosis
|
0.00%
0/47 • Up to 2.6 years
|
2.0%
1/51 • Number of events 1 • Up to 2.6 years
|
Additional Information
Alex A. Adjei, M.D., Ph.D.
Roswell Park Cancer Institute
Phone: 507-284-9265
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60