Trial Outcomes & Findings for A Study Of Everolimus, Trastuzumab And Vinorelbine In HER2-Positive Breast Cancer Brain Metastases (NCT NCT01305941)
NCT ID: NCT01305941
Last Updated: 2018-12-17
Results Overview
response will be evaluated via gadolinium-enhanced brain MRI using modified RECIST criteria. Complete Response (CR) - Disappearance of all target and nontarget 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 longest diameter AND an absolute decrease of at least 5mm in at least one target lesion. Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started. Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size.
COMPLETED
PHASE2
32 participants
3 years
2018-12-17
Participant Flow
Subjects were recruited from 4 institutions between September, 2011 and May, 2016.
A total of 41 patients were consented to this study. Of these, 6 patients were found ineligible, 2 withdrew prior to treatment, and 1 patient has disease progression prior to protocol therapy. Therefore only 32 patients were enrolled and participated in the trial.
Participant milestones
| Measure |
Everolimus +Vinorelbine + Trastuzumab
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Everolimus +Vinorelbine + Trastuzumab
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Clinical decline
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
A Study Of Everolimus, Trastuzumab And Vinorelbine In HER2-Positive Breast Cancer Brain Metastases
Baseline characteristics by cohort
| Measure |
Everolimus +Vinorelbine + Trastuzumab
n=32 Participants
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
|
Stage at breast cancer diagnosis
0-III
|
19 Participants
n=5 Participants
|
|
Stage at breast cancer diagnosis
IV
|
13 Participants
n=5 Participants
|
|
Median time since first brain metastases (years)
|
1.12 years
n=5 Participants
|
|
Prior Systemic Chemotherapy (metastatic)
|
30 Participants
n=5 Participants
|
|
Prior metastatic chemotherapy lines, # (range)
|
2 Metastatic Lines
n=5 Participants
|
|
Prior anti-Her2 (metastatic) Agents
Trastuzumab
|
29 Participants
n=5 Participants
|
|
Prior anti-Her2 (metastatic) Agents
Lapatinib
|
22 Participants
n=5 Participants
|
|
Prior anti-Her2 (metastatic) Agents
Pertuzumab
|
12 Participants
n=5 Participants
|
|
Prior anti-Her2 (metastatic) Agents
Trastuzumab Emtansine (TDM-1)
|
8 Participants
n=5 Participants
|
|
Prior Central Nervous System Local Therapy
Surgery
|
10 Participants
n=5 Participants
|
|
Prior Central Nervous System Local Therapy
Whole brain radiation therapy
|
22 Participants
n=5 Participants
|
|
Prior Central Nervous System Local Therapy
Stereotactic Radiosurgery (SRS)
|
17 Participants
n=5 Participants
|
|
Recursive Partitioning Analysis (RPA) Score
Class 1
|
10 Participants
n=5 Participants
|
|
Recursive Partitioning Analysis (RPA) Score
Class 2
|
21 Participants
n=5 Participants
|
|
Recursive Partitioning Analysis (RPA) Score
Class 3
|
1 Participants
n=5 Participants
|
|
Steroid use at baseline
|
10 Participants
n=5 Participants
|
|
Extracranial disease at enrollment
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: Six subjects were not evaluable for response because there was no follow-up disease assessment done due to poor clinical status of subjects
response will be evaluated via gadolinium-enhanced brain MRI using modified RECIST criteria. Complete Response (CR) - Disappearance of all target and nontarget 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 longest diameter AND an absolute decrease of at least 5mm in at least one target lesion. Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started. Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size.
Outcome measures
| Measure |
Everolimus +Vinorelbine + Trastuzumab
n=26 Participants
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Intracranial Objective Response Rate- Modified RECIST Criteria
Complete Response
|
0 Participants
|
|
Intracranial Objective Response Rate- Modified RECIST Criteria
Partial Response
|
1 Participants
|
|
Intracranial Objective Response Rate- Modified RECIST Criteria
Stable Disease
|
17 Participants
|
|
Intracranial Objective Response Rate- Modified RECIST Criteria
Progressive Disease
|
8 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Six subjects were not evaluable for response because there was no follow-up disease assessment done due to poor clinical status of subjects
Intracranial tumor lesions were evaluated via gadolinium-enhanced brain MRI using the MacDonald criteria. Measurable disease is defined as at least 1 measurable brain lesion accurately measured in at least 2 dimensions (longest diameter) as ≥5.0 mm. Tumor size is the product of the 2 longest bi-dimensional lines. Complete Response (CR)- Disappearance of all tumor on consecutive CT or MRI scans at least 1 month apart, off steroids for treatment of neurological symptoms, and neurologically stable or improved. Partial Response (PR)- ≥50% reduction in size of tumor on consecutive CT or MRI scans at least 1 month part, steroids stable or reduced, and neurologically stable or improved. Progressive Disease (PD)- ≥25% increase in size of tumor or any new tumor on CT or MRI scans, or neurologically worse, and steroids stable or increased due to neurologic symptoms. Stable Disease (SD)- all other situations Overall Response Rate (ORR) is the sum of partial responses (PRs) and CRs.
Outcome measures
| Measure |
Everolimus +Vinorelbine + Trastuzumab
n=26 Participants
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Intracranial Response Rate- MacDonald Criteria
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 weeksGrade 3 or higher toxicities of interest are reported. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4. The NCI CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Outcome measures
| Measure |
Everolimus +Vinorelbine + Trastuzumab
n=32 Participants
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Toxicity
Alkaline phosphatase increased
|
1 Participants
|
|
Toxicity
Anemia
|
5 Participants
|
|
Toxicity
Anorexia
|
1 Participants
|
|
Toxicity
Asparate Aminotransferase Increased
|
2 Participants
|
|
Toxicity
Diarrhea
|
1 Participants
|
|
Toxicity
Febrile Neutropenia
|
2 Participants
|
|
Toxicity
Hyperkalemia
|
1 Participants
|
|
Toxicity
Lymphocyte Count Decreased
|
3 Participants
|
|
Toxicity
Mucositis Oral
|
5 Participants
|
|
Toxicity
Neutrophil Count Decreased
|
13 Participants
|
|
Toxicity
Pneumonitis
|
1 Participants
|
|
Toxicity
Sepsis
|
3 Participants
|
|
Toxicity
White Blood Cell Decreased
|
11 Participants
|
SECONDARY outcome
Timeframe: 3 yearsTime to intracranial progression after administration of everolimus in combination with trastuzumab and vinorelbine as defined via modified RECIST criteria. Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size.
Outcome measures
| Measure |
Everolimus +Vinorelbine + Trastuzumab
n=32 Participants
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Time to Intracranial Progression.
|
3.93 months
Interval 2.27 to 5.0
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Seven subjects were not evaluable for extra-cranial response because there was no follow-up disease assessment done due to poor clinical status of subjects. An additional 12 subjects were excluded since they did not have extra-cranial disease at baseline and one additional subject was non compliant for follow-up scans.
Extracranial response was measured using RECIST 1.1 criteria and defined as the number of subjects achieving CR or PR. Complete Response (CR) - Disappearance of all target and nontarget 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 longest diameter AND an absolute decrease of at least 5mm in at least one target lesion. Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started. Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size.
Outcome measures
| Measure |
Everolimus +Vinorelbine + Trastuzumab
n=12 Participants
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Extracranial Response
|
5 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Seven subjects were not evaluable for extra-cranial response due to no follow-up disease assessments due to poor clinical status; 12 subjects were excluded since they did not have extra-cranial disease at baseline; 1 subject was non compliant for follow-up scans; and 1 subject was excluded due to intracranial progression prior to extracranial.
To evaluate the extracranial time to progression as determined by RECIST 1.1 criteria after administration of everolimus in combination with trastuzumab and vinorelbine. Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size.
Outcome measures
| Measure |
Everolimus +Vinorelbine + Trastuzumab
n=6 Participants
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Extracranial Time to Progression
|
4.01 months
Interval 1.97 to 8.26
|
SECONDARY outcome
Timeframe: 3 yearsOverall survival (OS) after administration of everolimus in combination with trastuzumab and vinorelbine
Outcome measures
| Measure |
Everolimus +Vinorelbine + Trastuzumab
n=32 Participants
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Overall Survival
|
1.01 years
Interval 0.57 to 1.78
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: Quality of life was an optional assessment for patients, so results are only reported for subjects who completed questionnaires at each timepoint
The FACT-Br is a 23-question self-report questionnaire subscale administered with the Functional Assessment of Cancer Therapy- General (FACT-G) which contains concerns relevant to patients with brain tumors . Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. Total scores on the FACT-Br subscale range from 0 to 92 with lower scores indicating declining quality of life. The change from baseline is the difference in scores between the baseline and 9 week assessments.
Outcome measures
| Measure |
Everolimus +Vinorelbine + Trastuzumab
n=9 Participants
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Functional Assessment of Cancer Therapy- Brain (FACT-Br) Change From Baseline to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life
|
-1.0 units on a scale
Interval -5.0 to 4.8
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: Quality of life was an optional assessment for patients, so results are only reported for subjects who completed questionnaires at each timepoint
The FACT-B is a 10-question self-report questionnaire subscale administered with the Functional Assessment of Cancer Therapy- General (FACT-G) which contains concerns relevant to patients with breast cancer. Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. Total scores on the FACT-B subscale range from 0 to 40 with lower scores indicating declining quality of life. The change from baseline is the difference in scores between the baseline and 9 week assessments.
Outcome measures
| Measure |
Everolimus +Vinorelbine + Trastuzumab
n=11 Participants
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Functional Assessment Cancer Therapy- Breast (FACT-B) From Baseline to 9 Weeks of Treatment to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life
|
1.0 units on a scale
Interval -2.0 to 3.0
|
Adverse Events
Everolimus +Vinorelbine + Trastuzumab
Serious adverse events
| Measure |
Everolimus +Vinorelbine + Trastuzumab
n=32 participants at risk
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Endocrine disorders
Adrenal Insufficiency
|
3.1%
1/32 • 24 weeks
|
|
Immune system disorders
Anaphylaxis
|
3.1%
1/32 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
3.1%
1/32 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.1%
1/32 • 24 weeks
|
|
Psychiatric disorders
Confusion
|
3.1%
1/32 • 24 weeks
|
|
Investigations
Creatinine Increased
|
6.2%
2/32 • 24 weeks
|
|
General disorders
Fever
|
6.2%
2/32 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.1%
1/32 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.1%
1/32 • 24 weeks
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.1%
1/32 • 24 weeks
|
|
General disorders
Infusion related reaction
|
3.1%
1/32 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Hemorrhage
|
3.1%
1/32 • 24 weeks
|
|
Infections and infestations
Lung Infection
|
3.1%
1/32 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
3.1%
1/32 • 24 weeks
|
|
General disorders
Pain
|
3.1%
1/32 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.1%
1/32 • 24 weeks
|
|
Nervous system disorders
Seizure
|
6.2%
2/32 • 24 weeks
|
|
Infections and infestations
Sepsis
|
9.4%
3/32 • 24 weeks
|
|
Nervous system disorders
Tremor
|
3.1%
1/32 • 24 weeks
|
|
Infections and infestations
Upper Respiratory Infection
|
3.1%
1/32 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • 24 weeks
|
Other adverse events
| Measure |
Everolimus +Vinorelbine + Trastuzumab
n=32 participants at risk
daily everolimus plus weekly (Days 1, 8, and 15) vinorelbine and trastuzumab
Everolimus: everolimus 5 mg PO daily as two 2.5-mg tablets
Vinorelbine: vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
Trastuzumab: 2 mg/kg IV administered over 30 minutes weekly
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
2/32 • 24 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
6.2%
2/32 • 24 weeks
|
|
Investigations
Alanine aminotransferase increased
|
28.1%
9/32 • 24 weeks
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
4/32 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
4/32 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
34.4%
11/32 • 24 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
31.2%
10/32 • 24 weeks
|
|
Psychiatric disorders
Anxiety
|
9.4%
3/32 • 24 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
28.1%
9/32 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
3/32 • 24 weeks
|
|
Investigations
Blood bilirubin increased
|
9.4%
3/32 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
2/32 • 24 weeks
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
2/32 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
37.5%
12/32 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
6/32 • 24 weeks
|
|
Investigations
Creatinine increased
|
9.4%
3/32 • 24 weeks
|
|
Psychiatric disorders
Depression
|
15.6%
5/32 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
8/32 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • 24 weeks
|
|
Nervous system disorders
Dysphasia
|
6.2%
2/32 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.4%
3/32 • 24 weeks
|
|
General disorders
Edema limbs
|
9.4%
3/32 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.4%
3/32 • 24 weeks
|
|
Eye disorders
Eye Disorders - Other, Specify
|
6.2%
2/32 • 24 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
2/32 • 24 weeks
|
|
General disorders
Fatigue
|
43.8%
14/32 • 24 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.2%
2/32 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
2/32 • 24 weeks
|
|
General disorders
Flu like symptoms
|
6.2%
2/32 • 24 weeks
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.2%
2/32 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.4%
3/32 • 24 weeks
|
|
Nervous system disorders
Headache
|
34.4%
11/32 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
4/32 • 24 weeks
|
|
Vascular disorders
Hypertension
|
6.2%
2/32 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.2%
2/32 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
2/32 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.6%
5/32 • 24 weeks
|
|
Infections and infestations
Infections And Infestations - Other, Specify
|
6.2%
2/32 • 24 weeks
|
|
Psychiatric disorders
Insomnia
|
18.8%
6/32 • 24 weeks
|
|
Investigations
Lymphocyte count decreased
|
18.8%
6/32 • 24 weeks
|
|
Nervous system disorders
Memory impairment
|
6.2%
2/32 • 24 weeks
|
|
Infections and infestations
Mucosal infection
|
6.2%
2/32 • 24 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
65.6%
21/32 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.2%
2/32 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder - Other, Specify
|
18.8%
6/32 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.4%
3/32 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.4%
3/32 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
21.9%
7/32 • 24 weeks
|
|
Investigations
Neutrophil count decreased
|
53.1%
17/32 • 24 weeks
|
|
General disorders
Pain
|
21.9%
7/32 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
2/32 • 24 weeks
|
|
Infections and infestations
Papulopustular rash
|
6.2%
2/32 • 24 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.1%
9/32 • 24 weeks
|
|
Investigations
Platelet count decreased
|
21.9%
7/32 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.2%
2/32 • 24 weeks
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
2/32 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
18.8%
6/32 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.4%
3/32 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders - Other, Specify
|
6.2%
2/32 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other, Specify
|
6.2%
2/32 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.2%
2/32 • 24 weeks
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
4/32 • 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
25.0%
8/32 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
4/32 • 24 weeks
|
|
Investigations
Weight loss
|
6.2%
2/32 • 24 weeks
|
|
Investigations
White blood cell decreased
|
46.9%
15/32 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60