Trial Outcomes & Findings for Temsirolimus and Bevacizumab in Treating Patients With Stage III or Stage IV Malignant Melanoma (NCT NCT00397982)
NCT ID: NCT00397982
Last Updated: 2017-06-09
Results Overview
Evaluated using Response Evaluation Criteria In Solid Tumor (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 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; Complete Response (CR), Disappearance of all target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Up to 18 weeks after registration.
Results posted on
2017-06-09
Participant Flow
Enrollment from Jan 2008 - Feb 2011 at the University of Virginia Cancer Center and Fox Chase Cancer Center.
Participant milestones
| Measure |
Treatment (Enzyme Inhibitor, Monoclonal Antibody)
Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV
Therapeutic Conventional Surgery: Undergo tumor resection
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Enzyme Inhibitor, Monoclonal Antibody)
Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV
Therapeutic Conventional Surgery: Undergo tumor resection
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
noncompliance
|
1
|
|
Overall Study
Unrelated health issues
|
1
|
Baseline Characteristics
Temsirolimus and Bevacizumab in Treating Patients With Stage III or Stage IV Malignant Melanoma
Baseline characteristics by cohort
| Measure |
Entire Study
n=17 Participants
Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV
Therapeutic Conventional Surgery: Undergo tumor resection
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 18 weeks after registration.Evaluated using Response Evaluation Criteria In Solid Tumor (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 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; Complete Response (CR), Disappearance of all target lesions.
Outcome measures
| Measure |
Entire Study
n=17 Participants
Treatment
|
|---|---|
|
Objective Tumor Response (Complete Response and Partial Response) and Progression in Participants With Stage III or IV Melanoma Following Treatment With Temsirolimus and Bevacizumab
Stable disease at 8 weeks
|
9 participants
|
|
Objective Tumor Response (Complete Response and Partial Response) and Progression in Participants With Stage III or IV Melanoma Following Treatment With Temsirolimus and Bevacizumab
Progressive disease
|
4 participants
|
|
Objective Tumor Response (Complete Response and Partial Response) and Progression in Participants With Stage III or IV Melanoma Following Treatment With Temsirolimus and Bevacizumab
not evaluable
|
1 participants
|
|
Objective Tumor Response (Complete Response and Partial Response) and Progression in Participants With Stage III or IV Melanoma Following Treatment With Temsirolimus and Bevacizumab
Partial response
|
3 participants
|
SECONDARY outcome
Timeframe: On days 1 and 8 of each cycle, and up to 2 years after registration.Population: Treatment related adverse events.
Defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during the study (having been absent at baseline) or if present at baseline, appears to worsen. Graded using scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Tabulated by type and severity: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Outcome measures
| Measure |
Entire Study
n=17 Participants
Treatment
|
|---|---|
|
Adverse Events in Participants With Stage III or IV Melanoma Treated With Temsirolimus and Bevacizumab
grade 3 hypokalemia
|
2 participants
|
|
Adverse Events in Participants With Stage III or IV Melanoma Treated With Temsirolimus and Bevacizumab
grade 3 hypophosphatemia
|
2 participants
|
|
Adverse Events in Participants With Stage III or IV Melanoma Treated With Temsirolimus and Bevacizumab
grade 3 weight loss
|
2 participants
|
|
Adverse Events in Participants With Stage III or IV Melanoma Treated With Temsirolimus and Bevacizumab
grade 4 lymphopenia
|
2 participants
|
|
Adverse Events in Participants With Stage III or IV Melanoma Treated With Temsirolimus and Bevacizumab
grade 2 leukoencephalopathy
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1 of course 1 and day 8 of course 2Population: This analysis was performed for those participants with sufficient tumor available for analysis.
Changes in the ratio of phospho-S6Kinase (pS6K) S240/244 to total S6, in the tumor, from day 1 to day 23. These were assessed by reverse-phase protein array. A linear model was fit with PROC MIXED in SAS 9.3 using the log base 10 of expression as the outcome measure. This measure type is not listed in the data table form; so the number of patients who had decreases in that ratio is listed.
Outcome measures
| Measure |
Entire Study
n=13 Participants
Treatment
|
|---|---|
|
Association Between Expression or Activation of One Biomarker With Another, With Biochemical and Clinical Responses, With Alterations in Cell Proliferation and Apoptotic Markers, and With Time to Progression
|
13 participants who had decreases in ratio
|
SECONDARY outcome
Timeframe: Day 1 of course 1 and day 8 of course 2Population: Patients evaluable for clinical outcome with BRAF mutation status.
Assessed in both tumor tissue pretreatment. Mutations in BRAF were assessed in all 16 of the patients and were assessed for any association with clinical response
Outcome measures
| Measure |
Entire Study
n=16 Participants
Treatment
|
|---|---|
|
Comparison of Biomarkers to Antitumor Activity/Patient Outcomes
BRAF-wild type · Partial responses
|
3 Participants
|
|
Comparison of Biomarkers to Antitumor Activity/Patient Outcomes
BRAF-wild type · Stable disease at 8 wks
|
5 Participants
|
|
Comparison of Biomarkers to Antitumor Activity/Patient Outcomes
BRAF-wild type · Progressive disease
|
2 Participants
|
|
Comparison of Biomarkers to Antitumor Activity/Patient Outcomes
BRAF-mutant · Partial responses
|
0 Participants
|
|
Comparison of Biomarkers to Antitumor Activity/Patient Outcomes
BRAF-mutant · Stable disease at 8 wks
|
4 Participants
|
|
Comparison of Biomarkers to Antitumor Activity/Patient Outcomes
BRAF-mutant · Progressive disease
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 of course 1 and day 8 of course 2Population: Detailed vascular changes were not assessed.
Biomarker expression in tumor and normal skin will be assessed by immunohistochemistry (IHC) or Western blotting, using marker-specific antibodies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 11 of courses 4, 8, 12, 16, 20, and 24, and then annually for up to 5 yearsPopulation: Entire study
Defined as the duration of time from start of treatment to time of progression, death or date of last follow-up.
Outcome measures
| Measure |
Entire Study
n=17 Participants
Treatment
|
|---|---|
|
Progression-free Survival
|
4.6 months
Interval 1.1 to 32.7
|
Adverse Events
Entire Study
Serious events: 9 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Entire Study
n=17 participants at risk
Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV
Therapeutic Conventional Surgery: Undergo tumor resection
|
|---|---|
|
Nervous system disorders
Leukoencephalopathy
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Blood and lymphatic system disorders
lymphopenia
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Blood and lymphatic system disorders
Anemia
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Infections and infestations
Opportunistic infection
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Cardiac disorders
Hypertension
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
Mucositis (funct/sympt) - Oral cavity
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
General disorders
Pain - Abdomen NOS
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
General disorders
Pain - Head/headache
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
General disorders
weight loss
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
anorexia
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Blood and lymphatic system disorders
low CD4 count
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
Other adverse events
| Measure |
Entire Study
n=17 participants at risk
Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.
Bevacizumab: Given IV
Laboratory Biomarker Analysis: Correlative studies
Temsirolimus: Given IV
Therapeutic Conventional Surgery: Undergo tumor resection
|
|---|---|
|
Immune system disorders
Rhinitis
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
29.4%
5/17 • Number of events 5 • Up to 2 years after registration
CTCAE 3.0.
|
|
Cardiac disorders
Hypertension
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
General disorders
Fatigue
|
64.7%
11/17 • Number of events 11 • Up to 2 years after registration
CTCAE 3.0.
|
|
Skin and subcutaneous tissue disorders
Pruritis/itching
|
47.1%
8/17 • Number of events 8 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
Mucositis - funct/sympt oral
|
41.2%
7/17 • Number of events 7 • Up to 2 years after registration
CTCAE 3.0.
|
|
Blood and lymphatic system disorders
Hemorrhage / Bleeding
|
47.1%
8/17 • Number of events 8 • Up to 2 years after registration
CTCAE 3.0.
|
|
Infections and infestations
Infection, normal ANC, abdomen
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Blood and lymphatic system disorders
Edema - limb
|
23.5%
4/17 • Number of events 4 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
Nausea
|
52.9%
9/17 • Number of events 9 • Up to 2 years after registration
CTCAE 3.0.
|
|
Renal and urinary disorders
Urinary frequency
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Cardiac disorders
Hypotension
|
23.5%
4/17 • Number of events 4 • Up to 2 years after registration
CTCAE 3.0.
|
|
General disorders
Fever
|
35.3%
6/17 • Number of events 6 • Up to 2 years after registration
CTCAE 3.0.
|
|
General disorders
Rigors/chills
|
52.9%
9/17 • Number of events 9 • Up to 2 years after registration
CTCAE 3.0.
|
|
General disorders
Sweating
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
76.5%
13/17 • Number of events 13 • Up to 2 years after registration
CTCAE 3.0.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
70.6%
12/17 • Number of events 12 • Up to 2 years after registration
CTCAE 3.0.
|
|
Skin and subcutaneous tissue disorders
Rash - acneiform
|
35.3%
6/17 • Number of events 6 • Up to 2 years after registration
CTCAE 3.0.
|
|
Skin and subcutaneous tissue disorders
Wound complications, non-infectious
|
23.5%
4/17 • Number of events 4 • Up to 2 years after registration
CTCAE 3.0.
|
|
Skin and subcutaneous tissue disorders
Hair loss / alopecia
|
17.6%
3/17 • Number of events 3 • Up to 2 years after registration
CTCAE 3.0.
|
|
Skin and subcutaneous tissue disorders
Dermatology - other
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
General disorders
Weight loss
|
52.9%
9/17 • Number of events 9 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
Anorexia
|
70.6%
12/17 • Number of events 12 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
vomiting
|
29.4%
5/17 • Number of events 5 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
mucositis - larynx
|
17.6%
3/17 • Number of events 3 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
dry mouth
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
mucositis - esophagus
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
colitis
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
dehydration
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
GI - other
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Blood and lymphatic system disorders
Hemorrhage - lung
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Blood and lymphatic system disorders
Hemorrhage - rectal
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Infections and infestations
Infection, normal ANC, oral cavity
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Infections and infestations
Infection (other)
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Blood and lymphatic system disorders
Edema - head and neck
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
Hypophosphatemia
|
17.6%
3/17 • Number of events 3 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
Hypokalemia
|
17.6%
3/17 • Number of events 3 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
Proteinuria
|
41.2%
7/17 • Number of events 7 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
hypertriglyceridemia
|
52.9%
9/17 • Number of events 9 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
AST
|
47.1%
8/17 • Number of events 8 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
Alkaline phosphatase
|
29.4%
5/17 • Number of events 5 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
Bilirubin
|
23.5%
4/17 • Number of events 4 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
Creatinine
|
17.6%
3/17 • Number of events 3 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
Hypoalbuminemia
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
Cholesterol
|
58.8%
10/17 • Number of events 10 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
low serum bicarbonate
|
41.2%
7/17 • Number of events 7 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
ALT
|
23.5%
4/17 • Number of events 4 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
hyponatremia
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
acidosis
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
hemoglobinuria
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
hypercalcemia
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
hypernatremia
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
hypomagnesemia
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.5%
4/17 • Number of events 4 • Up to 2 years after registration
CTCAE 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - other
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Musculoskeletal and connective tissue disorders
Pain - extremity
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Musculoskeletal and connective tissue disorders
Pain - joint
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Musculoskeletal and connective tissue disorders
Pain - muscle
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pain - oral cavity
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pain - chest wall
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pain - oral - gums
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
General disorders
Pain - other
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Skin and subcutaneous tissue disorders
Pain - scalp
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Skin and subcutaneous tissue disorders
Pain - skin
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
pain - throat
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
General disorders
flu-like syndrome
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
Pain - anus
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
Pain - stomach
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - tumor
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
Pain - abdomen NOS
|
17.6%
3/17 • Number of events 3 • Up to 2 years after registration
CTCAE 3.0.
|
|
Nervous system disorders
Pain - headache
|
41.2%
7/17 • Number of events 7 • Up to 2 years after registration
CTCAE 3.0.
|
|
Blood and lymphatic system disorders
hemoglobin
|
76.5%
13/17 • Number of events 13 • Up to 2 years after registration
CTCAE 3.0.
|
|
Blood and lymphatic system disorders
Platelets (thrombocytopenia)
|
82.4%
14/17 • Number of events 14 • Up to 2 years after registration
CTCAE 3.0.
|
|
Endocrine disorders
Hyperglycemia
|
47.1%
8/17 • Number of events 8 • Up to 2 years after registration
CTCAE 3.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
Diarrhea
|
58.8%
10/17 • Number of events 10 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
mucositis - clinical exam - oral
|
58.8%
10/17 • Number of events 10 • Up to 2 years after registration
CTCAE 3.0.
|
|
Blood and lymphatic system disorders
Leukocytes
|
35.3%
6/17 • Number of events 6 • Up to 2 years after registration
CTCAE 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.3%
6/17 • Number of events 6 • Up to 2 years after registration
CTCAE 3.0.
|
|
Blood and lymphatic system disorders
Neutrophils
|
23.5%
4/17 • Number of events 4 • Up to 2 years after registration
CTCAE 3.0.
|
|
Nervous system disorders
Neuropathy - sensory
|
17.6%
3/17 • Number of events 3 • Up to 2 years after registration
CTCAE 3.0.
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Reproductive system and breast disorders
mucositis - vaginal
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
taste alteration
|
58.8%
10/17 • Number of events 10 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
constipation
|
35.3%
6/17 • Number of events 6 • Up to 2 years after registration
CTCAE 3.0.
|
|
General disorders
voice changes
|
35.3%
6/17 • Number of events 6 • Up to 2 years after registration
CTCAE 3.0.
|
|
Investigations
Hypocalcemia
|
23.5%
4/17 • Number of events 4 • Up to 2 years after registration
CTCAE 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
nasal/paranasal reactions
|
17.6%
3/17 • Number of events 3 • Up to 2 years after registration
CTCAE 3.0.
|
|
Nervous system disorders
cognitive disturbance
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Ear and labyrinth disorders
Dizziness
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Gastrointestinal disorders
Heartburn
|
11.8%
2/17 • Number of events 2 • Up to 2 years after registration
CTCAE 3.0.
|
|
Skin and subcutaneous tissue disorders
hypopigmentation - skin
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Skin and subcutaneous tissue disorders
urticaria
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Nervous system disorders
Confusion
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Nervous system disorders
Memory impairment
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Nervous system disorders
Mood alteration - anxiety
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • Number of events 1 • Up to 2 years after registration
CTCAE 3.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60