Trial Outcomes & Findings for Phase II Study of Alternating Sunitinib and Temsirolimus (NCT NCT01517243)
NCT ID: NCT01517243
Last Updated: 2023-09-21
Results Overview
To determine the time to disease progression in metastatic renal cell carcinoma patients treated with alternating targeted therapy. This time interval constitutes the metric progression free survival time.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
From the date of randomization until the first documented disease progression or date of death from any cause, evaluated every 12 weeks throughout duration of study treatment
Results posted on
2023-09-21
Participant Flow
37 participants signed consent, of those, 3 withdrew consent and 15 were screen failures
Participant milestones
| Measure |
Alternating Sunitinib and Temsirolimus
A cycle is defined as:
Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
Sunitinib: Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest
Temsirolimus: Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Alternating Sunitinib and Temsirolimus
Baseline characteristics by cohort
| Measure |
Number of Participants Classified by Tumor Histology/Cytology
n=19 Participants
A cycle is defined as:
Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
Sunitinib: Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest
Temsirolimus: Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
63.0 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 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
|
19 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
|
19 participants
n=5 Participants
|
|
Tumor Histology/Cytology
Clear Cell
|
16 participants
n=5 Participants
|
|
Tumor Histology/Cytology
Papillary
|
1 participants
n=5 Participants
|
|
Tumor Histology/Cytology
Unclassified
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization until the first documented disease progression or date of death from any cause, evaluated every 12 weeks throughout duration of study treatmentTo determine the time to disease progression in metastatic renal cell carcinoma patients treated with alternating targeted therapy. This time interval constitutes the metric progression free survival time.
Outcome measures
| Measure |
Alternating Sunitinib and Temsirolimus
n=19 Participants
A cycle is defined as:
Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
Sunitinib: Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest
Temsirolimus: Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
|
|---|---|
|
Progression Free Survival
|
8.8 Months
Interval 6.8 to 25.2
|
SECONDARY outcome
Timeframe: Every 12 weeks from randomization until progression, estimated time frame is 18 monthsTo be assigned a status of partial response or complete response, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of stable disease, follow-up measurements must have met the stable disease criteria at least once after study entry at a minimum interval (in general, not less than 6-8 weeks) that is defined in the study protocol. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Alternating Sunitinib and Temsirolimus
n=19 Participants
A cycle is defined as:
Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
Sunitinib: Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest
Temsirolimus: Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
|
|---|---|
|
Clinical Response Rate as Measured by Best Response Achieved
Partial Response
|
5 Participants
|
|
Clinical Response Rate as Measured by Best Response Achieved
Stable Disease
|
9 Participants
|
|
Clinical Response Rate as Measured by Best Response Achieved
Progression of Disease
|
3 Participants
|
|
Clinical Response Rate as Measured by Best Response Achieved
Not Evaluable
|
2 Participants
|
SECONDARY outcome
Timeframe: Throughout the duration of the patient remaining on study treatment which was a median time of 8 monthsThe toxicity profile will be characterized by observations of AEs and SAEs graded by the CTCAE criteria v4.0.
Outcome measures
| Measure |
Alternating Sunitinib and Temsirolimus
n=19 Participants
A cycle is defined as:
Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
Sunitinib: Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest
Temsirolimus: Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
|
|---|---|
|
To Characterize the Toxicity Profile
|
19 participants
|
Adverse Events
Alternating Sunitinib and Temsirolimus
Serious events: 4 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Alternating Sunitinib and Temsirolimus
n=19 participants at risk
A cycle is defined as:
Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
Sunitinib: Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest
Temsirolimus: Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
|
|---|---|
|
Nervous system disorders
Dysarthia
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Vascular disorders
Ischemia Cerebrovascular (stroke)
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness- right sided
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Cardiac disorders
Atrial Fibrillation
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Renal and urinary disorders
Urosepsis
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia (w/ sepsis)
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
Other adverse events
| Measure |
Alternating Sunitinib and Temsirolimus
n=19 participants at risk
A cycle is defined as:
Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
Sunitinib: Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest
Temsirolimus: Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
|
|---|---|
|
Cardiac disorders
Hypertension
|
26.3%
5/19 • Number of events 6 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Alanine aminotransferase increased
|
15.8%
3/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Alkaline phosphatase increased
|
15.8%
3/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Immune system disorders
Allergic reaction (rash)
|
31.6%
6/19 • Number of events 7 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Amylase increased
|
15.8%
3/19 • Number of events 6 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Anemia
|
47.4%
9/19 • Number of events 9 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Metabolism and nutrition disorders
Anorexia
|
15.8%
3/19 • Number of events 3 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Aspartate aminotransferase increased
|
15.8%
3/19 • Number of events 3 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.8%
3/19 • Number of events 3 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Bloating
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Blood bilirubin increased
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Eye disorders
Blurred vision
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
General disorders
Chest pain
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
General disorders
Chills
|
10.5%
2/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Cholesterol high
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Nervous system disorders
Concentration impairment
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Constipation
|
15.8%
3/19 • Number of events 3 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.3%
5/19 • Number of events 5 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Creatinine increased
|
42.1%
8/19 • Number of events 12 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Psychiatric disorders
Depression
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
47.4%
9/19 • Number of events 10 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Nervous system disorders
Dysesthesia
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Nervous system disorders
Dysgeusia
|
36.8%
7/19 • Number of events 7 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Dyspepsia
|
15.8%
3/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.1%
4/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Ear and labyrinth disorders
Ear Pain
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
General disorders
Edema Limbs
|
21.1%
4/19 • Number of events 9 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
General disorders
Edema Face
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.1%
4/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Nervous system disorders
Facial Muscle Weakness
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
General disorders
Facial pain
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
General disorders
Fatigue
|
73.7%
14/19 • Number of events 17 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
General disorders
Fever
|
21.1%
4/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
General disorders
Flu like symptoms
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Injury, poisoning and procedural complications
Spinal Fracture (C6)
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Injury, poisoning and procedural complications
Fracture (rib)
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Gastronintestinal pain
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Skin and subcutaneous tissue disorders
Hair color changes
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Nervous system disorders
Headache
|
31.6%
6/19 • Number of events 6 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Ear and labyrinth disorders
Hearing Impaired
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Vascular disorders
Hot flashes
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.1%
4/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.3%
1/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.8%
3/19 • Number of events 3 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.8%
3/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.5%
2/19 • Number of events 7 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Cardiac disorders
Hypotension
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Infections and infestations
Skin infection
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
General disorders
Infusion site extravasation
|
5.3%
1/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
INR increased
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Psychiatric disorders
Insomnia
|
15.8%
3/19 • Number of events 3 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
General disorders
Pain- joint
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Blood Lactate dehydrogenase increased
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Injury, poisoning and procedural complications
Wound complication- hernia
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Nervous system disorders
Lethargy
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Infections and infestations
Lip Infection
|
10.5%
2/19 • Number of events 3 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Lipase Increased
|
15.8%
3/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Infections and infestations
Lung infection
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Nervous system disorders
Memory impairment
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Mucositis oral
|
52.6%
10/19 • Number of events 10 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.8%
3/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Infections and infestations
Nail infection
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Nausea
|
21.1%
4/19 • Number of events 5 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Neutrophil count decreased
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Oral pain
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
General disorders
Pain
|
5.3%
1/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
42.1%
8/19 • Number of events 8 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Pancreatitis
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Cardiac disorders
Pericarditis
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.5%
2/19 • Number of events 3 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Vascular disorders
Phlebitis
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Platelet count decreased
|
31.6%
6/19 • Number of events 10 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
White blood cell decreased
|
15.8%
3/19 • Number of events 8 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
15.8%
3/19 • Number of events 3 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.3%
1/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Renal and urinary disorders
Proteinuria
|
15.8%
3/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
15.8%
3/19 • Number of events 4 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
General disorders
Pain- right iliac
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Psychiatric disorders
Libido increased
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Nervous system disorders
Sinus pain
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Cardiac disorders
Ventricular tachycardia
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Toothache
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Infections and infestations
Upper Respiratory Infection
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Renal and urinary disorders
Urinary frequency
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Renal and urinary disorders
Urinary retention
|
10.5%
2/19 • Number of events 2 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Infections and infestations
urinary tract infection
|
10.5%
2/19 • Number of events 3 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Number of events 3 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Eye disorders
Watering eyes
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Investigations
Weight loss
|
15.8%
3/19 • Number of events 3 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected from the time consent was obtained until 4 weeks post progression, approximately 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place