Trial Outcomes & Findings for Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant (NCT NCT00141726)
NCT ID: NCT00141726
Last Updated: 2015-12-03
Results Overview
Response was defined as a greater than or equal to 10% improvement in the absolute value for FEV1 (for obstructive defects) or FVC (for restrictive defects), and DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) .
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
week 12 post therapy
Results posted on
2015-12-03
Participant Flow
Study subjects were recruited from the Blood and Marrow Stem Cell Program at the University of Michigan Medical Center between 2001 and 2008, all subjects having received an allogeneic Stem Cell Transplant (SCT) at least 100 days before study entry.
Participant milestones
| Measure |
Etanercept Treatment
Etanercept for lung injury
Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Etanercept Treatment
Etanercept for lung injury
Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.
|
|---|---|
|
Overall Study
Completed <50% Scheduled Dosing
|
3
|
Baseline Characteristics
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Etanercept Treatment
n=34 Participants
Etanercept for lung injury
Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.
|
|---|---|
|
Age, Continuous
|
39 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
|
Diagnosis
AML/MDS/MF
|
16 participants
n=93 Participants
|
|
Diagnosis
Acute Lymphoblastic Leukemia (ALL)
|
3 participants
n=93 Participants
|
|
Diagnosis
Chronic Mylogenous Leukemia (CML)
|
5 participants
n=93 Participants
|
|
Diagnosis
NHL/CLL
|
6 participants
n=93 Participants
|
|
Diagnosis
Myeloma
|
2 participants
n=93 Participants
|
|
Diagnosis
Nonmalignant
|
2 participants
n=93 Participants
|
|
Human Leukocyte Antigen (HLA) Match
HLA Matched
|
31 participants
n=93 Participants
|
|
Human Leukocyte Antigen (HLA) Match
Mismatch
|
3 participants
n=93 Participants
|
|
Cell Source
Pluripotent Stem Cell (PSC)
|
25 participants
n=93 Participants
|
|
Cell Source
Marrow
|
9 participants
n=93 Participants
|
|
Donor Type
Matched Related Donor (MRD)
|
22 participants
n=93 Participants
|
|
Donor Type
Unrelated Donor (URD)
|
12 participants
n=93 Participants
|
|
Chronic Graft Versus Host Disease (GVHD) Present
Yes
|
34 participants
n=93 Participants
|
|
Chronic Graft Versus Host Disease (GVHD) Present
No
|
0 participants
n=93 Participants
|
|
Lung Injury Pattern
Restrictive
|
9 participants
n=93 Participants
|
|
Lung Injury Pattern
Obstructive
|
25 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: week 12 post therapyPopulation: 34 subjects were enrolled. Thirty-one of 34 subjects were evaluable for response, with three subjects completing \<50% of scheduled dosing.
Response was defined as a greater than or equal to 10% improvement in the absolute value for FEV1 (for obstructive defects) or FVC (for restrictive defects), and DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) .
Outcome measures
| Measure |
Etanercept Treatment
n=31 Participants
Etanercept for lung injury
Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.
|
|---|---|
|
Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO
≥10% Improvement in FEV1 / FVC
|
32 percent evaluable participants
|
|
Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO
≥10% Improvement in DLCO
|
16 percent evaluable participants
|
SECONDARY outcome
Timeframe: continuously (and week 4, week 8 and week 12, week 20)Population: 34 subjects were enrolled and evaluated for adverse events.
To evaluate the toxicity of etanercept therapy in patients with sub-acute lung injury \> 100 days post transplant, the percent incidence of grade 3 to 4 adverse events among evaluable patients was calculated.
Outcome measures
| Measure |
Etanercept Treatment
n=34 Participants
Etanercept for lung injury
Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.
|
|---|---|
|
Percentage of Participants That Experience Grade 3 to 4 Adverse Events
Incidence of Grade 3 to 4 Pain
|
6 percentage of participants
|
|
Percentage of Participants That Experience Grade 3 to 4 Adverse Events
Incidence of Grade 3 to 4 Hypertension
|
3 percentage of participants
|
|
Percentage of Participants That Experience Grade 3 to 4 Adverse Events
Incidence of Grade 3 to 4 GI Toxicities
|
3 percentage of participants
|
|
Percentage of Participants That Experience Grade 3 to 4 Adverse Events
Incidence of Grade 3 to 4 CNS Toxicities
|
3 percentage of participants
|
|
Percentage of Participants That Experience Grade 3 to 4 Adverse Events
Incidence of Grade 3 to 4 Thrombocytopenia
|
3 percentage of participants
|
|
Percentage of Participants That Experience Grade 3 to 4 Adverse Events
Incidence of Grad 3 to 4 Infection
|
14 percentage of participants
|
|
Percentage of Participants That Experience Grade 3 to 4 Adverse Events
Incidence of Grade 3 to 4 Electrolyte Toxicities
|
11 percentage of participants
|
|
Percentage of Participants That Experience Grade 3 to 4 Adverse Events
Incidence of Grade 3 to 4 Hyperglycemia
|
8 percentage of participants
|
|
Percentage of Participants That Experience Grade 3 to 4 Adverse Events
Incidence of Grade 3 to 4 Renal/GU Toxicities
|
6 percentage of participants
|
|
Percentage of Participants That Experience Grade 3 to 4 Adverse Events
Incidence of Grade 3 to 4 Hepatic Toxicities
|
6 percentage of participants
|
Adverse Events
Etanercept Treatment
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Etanercept Treatment
n=34 participants at risk
Etanercept for lung injury
Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.9%
1/34 • Number of events 1 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.9%
1/34 • Number of events 1 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/34 • Number of events 1 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Infections and infestations
Bacteremia/Infection
|
2.9%
1/34 • Number of events 1 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
AML Relapse
|
2.9%
1/34 • Number of events 1 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
Other adverse events
| Measure |
Etanercept Treatment
n=34 participants at risk
Etanercept for lung injury
Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.6%
7/34 • Number of events 7 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
anorexia
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Skin and subcutaneous tissue disorders
blisters
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
General disorders
chills
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Gastrointestinal disorders
constipation
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
bronchoalveolar lavage - positive for bacteria
|
11.8%
4/34 • Number of events 6 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Endocrine disorders
cushingoid appearance
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Gastrointestinal disorders
diarrhea
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Nervous system disorders
dizzyness
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Vascular disorders
DVT
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Gastrointestinal disorders
dysphagia
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
35.3%
12/34 • Number of events 12 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Renal and urinary disorders
dysuria
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Vascular disorders
Ecchymosis
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Investigations
elevated Alkaline Phoshpatase
|
23.5%
8/34 • Number of events 8 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Investigations
elevated ALT
|
35.3%
12/34 • Number of events 12 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Investigations
elevated AST
|
35.3%
12/34 • Number of events 12 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Investigations
elevated Creatinine
|
23.5%
8/34 • Number of events 8 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Investigations
elevated T-bili
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
General disorders
fatigue
|
11.8%
4/34 • Number of events 4 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
General disorders
fever
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Gastrointestinal disorders
gastroenteritis
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Nervous system disorders
headache
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Renal and urinary disorders
hematuria
|
8.8%
3/34 • Number of events 4 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
hypercalcemia
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
47.1%
16/34 • Number of events 16 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
14.7%
5/34 • Number of events 5 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
hyperphosphatemia
|
11.8%
4/34 • Number of events 4 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Vascular disorders
hypertension
|
11.8%
4/34 • Number of events 5 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
hypertriglyceridemia
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
23.5%
8/34 • Number of events 8 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
14.7%
5/34 • Number of events 5 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
hypokalemia
|
11.8%
4/34 • Number of events 4 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
14.7%
5/34 • Number of events 5 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
hyponatremia
|
11.8%
4/34 • Number of events 4 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
17.6%
6/34 • Number of events 6 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Vascular disorders
hypotension
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Psychiatric disorders
insomnia
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Cardiac disorders
irregular heart beat
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Skin and subcutaneous tissue disorders
pruitis
|
11.8%
4/34 • Number of events 4 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
General disorders
leg edema
|
11.8%
4/34 • Number of events 4 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Blood and lymphatic system disorders
leukopenia
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
General disorders
lower extremity soreness
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Blood and lymphatic system disorders
lymphopenia
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Musculoskeletal and connective tissue disorders
muscle cramps
|
23.5%
8/34 • Number of events 8 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal range of motion
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Gastrointestinal disorders
nausea
|
11.8%
4/34 • Number of events 4 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Renal and urinary disorders
nocturia
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Skin and subcutaneous tissue disorders
rash
|
14.7%
5/34 • Number of events 5 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
11.8%
4/34 • Number of events 5 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
General disorders
tremors
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Gastrointestinal disorders
vomiting
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
General disorders
weakness
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Investigations
weight gain
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Investigations
weight loss
|
5.9%
2/34 • Number of events 2 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Infections and infestations
infection
|
8.8%
3/34 • Number of events 3 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
|
Infections and infestations
UTI
|
8.8%
3/34 • Number of events 4 • Adverse Events (AEs) were collected for each patient from time of administration of the first dose of drug up to 28 days after the final dose of study drug.
Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.
|
Additional Information
Gregory Yanik, M.D.
University of Michgan Comprehensive Cancer Center
Phone: 734-936-8785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place