Trial Outcomes & Findings for PAZOPANIB Efficacy and Tolerance in Desmoids Tumors (NCT NCT01876082)
NCT ID: NCT01876082
Last Updated: 2025-09-04
Results Overview
Percentage of patients remaining alive and progression-free at 6 months as per RECIST 1.1 after the day of randomisation. Progression is defined using New Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), or a unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
6 months
Results posted on
2025-09-04
Participant Flow
Participant milestones
| Measure |
PAZOPANIB
Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
PAZOPANIB treatment: Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
|
Vinblastine and Methotrexate
vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
Active Comparator: Vinblastine and Methotrexate: Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
24
|
|
Overall Study
Safety Population
|
48
|
22
|
|
Overall Study
COMPLETED
|
46
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
PAZOPANIB
Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
PAZOPANIB treatment: Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
|
Vinblastine and Methotrexate
vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
Active Comparator: Vinblastine and Methotrexate: Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
treatment interruption of more than 21 consecutive days observed in cycle 1
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PAZOPANIB
n=48 Participants
Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
PAZOPANIB treatment: Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
|
Vinblastine and Methotrexate
n=24 Participants
vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
Active Comparator: Vinblastine and Methotrexate: Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.5 years
n=48 Participants
|
42.5 years
n=24 Participants
|
39.8 years
n=72 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=48 Participants
|
15 Participants
n=24 Participants
|
46 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=48 Participants
|
9 Participants
n=24 Participants
|
26 Participants
n=72 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
48 participants
n=48 Participants
|
24 participants
n=24 Participants
|
72 participants
n=72 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Population evaluable for efficacy included all patients who met eligibility criteria and had received at least one complete cycle or two incomplete cycles of treatment.
Percentage of patients remaining alive and progression-free at 6 months as per RECIST 1.1 after the day of randomisation. Progression is defined using New Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), or a unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.
Outcome measures
| Measure |
PAZOPANIB
n=46 Participants
Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
PAZOPANIB treatment: Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
|
Vinblastine and Methotrexate
n=20 Participants
vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
Active Comparator: Vinblastine and Methotrexate: Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
|
|---|---|---|
|
Percentage of Patients Remaining Alive and Progression-free at 6 Months as Per RECIST 1.1 After the Day of Randomisation (6-month Non-progression Rate).
|
84.8 percentage of participants
Interval 71.1 to 93.7
|
45.0 percentage of participants
Interval 23.1 to 68.5
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Population evaluable for efficacy included all patients who met eligibility criteria and had received at least one complete cycle or two incomplete cycles of treatment.
Best overall response is defined as the best response across all time points (RECIST v1.1). The best overall response is determined once all the data for the participant is known. Each patient has been assigned one of the following categories (RECIST 1.1): complete response (disappearance of all target lesions); partial response (\>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); progression (20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and stable disease (nor CR, PR or progression).
Outcome measures
| Measure |
PAZOPANIB
n=46 Participants
Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
PAZOPANIB treatment: Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
|
Vinblastine and Methotrexate
n=20 Participants
vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
Active Comparator: Vinblastine and Methotrexate: Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
|
|---|---|---|
|
Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1.
Complete response
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1.
Partial response
|
41.3 percentage of participants
Interval 27.0 to 56.8
|
30.0 percentage of participants
Interval 11.9 to 54.3
|
|
Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1.
Stable disease
|
54.4 percentage of participants
Interval 39.0 to 69.1
|
45.0 percentage of participants
Interval 23.1 to 68.5
|
|
Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1.
Progression
|
4.4 percentage of participants
Interval 0.5 to 14.8
|
20.0 percentage of participants
Interval 5.7 to 43.7
|
|
Percentage of Patients Remaining Alive With Best Overall Response as Per RECIST v1.1.
Inevaluable for response
|
0 percentage of participants
Interval 0.0 to 0.0
|
5.0 percentage of participants
Interval 0.1 to 24.9
|
SECONDARY outcome
Timeframe: Randomization to disease progression, or death due to any cause, whichever occurs first; until 2 years after the last patient randomized.Progression-free survival (PFS) defined as the time from randomization to the first documented progression (as per RECIST v1.1) or death (due to any cause), whichever occurs first. Patients alive and progression free were censored at the date of last follow-up, death, or last patient contact. Progression is assessed as per RECIST v1.1. Progression-free survival is estimated as a function of time using Kaplan-Meier method. 1- and 2-year PFS rates were reported.
Outcome measures
| Measure |
PAZOPANIB
n=46 Participants
Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
PAZOPANIB treatment: Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
|
Vinblastine and Methotrexate
n=20 Participants
vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
Active Comparator: Vinblastine and Methotrexate: Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
|
|---|---|---|
|
Progression-free Survival
PFS rate at 1 year
|
84.8 percentage of participants
Interval 70.7 to 92.4
|
68.6 percentage of participants
Interval 43.0 to 84.5
|
|
Progression-free Survival
PFS rate at 2 years
|
65.2 percentage of participants
Interval 49.6 to 77.0
|
68.6 percentage of participants
Interval 43.0 to 84.5
|
SECONDARY outcome
Timeframe: Randomization to disease progression, or death due to any cause, whichever occurs first; until 2 years after the last patient randomized.Population: Population evaluable for efficacy included all patients who met eligibility criteria and had received at least one complete cycle or two incomplete cycles of treatment.
Overall survival (OS) defined as the time from randomization to death (due to any cause). Patients alive were censored at the date of last follow-up or last patient contact. Overall survival was estimated as a function of time using Kaplan-Meier method.1- and 2-Year OS rates were reported.
Outcome measures
| Measure |
PAZOPANIB
n=46 Participants
Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
PAZOPANIB treatment: Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
|
Vinblastine and Methotrexate
n=20 Participants
vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
Active Comparator: Vinblastine and Methotrexate: Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
|
|---|---|---|
|
Overall Survival
OS rate at 1 year
|
100.0 Percentage of participants
Only 1 patient from arm A died after 1 year hence insufficient patient with event to calculate the confidence limits for the 1-year OS rate.
|
100.0 Percentage of participants
Only 1 patient from arm A died after 1 year hence insufficient patient with event to calculate the confidence limits for the 1-year OS rate.
|
|
Overall Survival
OS rate at 2 years
|
97.8 Percentage of participants
Interval 85.6 to 99.7
|
100.0 Percentage of participants
Only 1 patient from arm A died after 1 year hence insufficient patient with event to calculate the confidence limits for the 2-year OS rate.
|
Adverse Events
PAZOPANIB
Serious events: 20 serious events
Other events: 48 other events
Deaths: 1 deaths
Vinblastine and Methotrexate
Serious events: 10 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PAZOPANIB
n=48 participants at risk
Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
PAZOPANIB treatment: Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
|
Vinblastine and Methotrexate
n=22 participants at risk
vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
Active Comparator: Vinblastine and Methotrexate: Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Eye disorders
Retinal detachment
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.1%
1/48 • Number of events 1 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/48 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
General disorders
Fever
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
General disorders
Infusion site extravasation
|
0.00%
0/48 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/48 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
Infections and infestations
Sepsis
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/48 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
Investigations
Neutrophil count decreased
|
4.2%
2/48 • Number of events 2 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/48 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.1%
1/48 • Number of events 2 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Nervous system disorders
Paresthesia
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/48 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/48 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Vascular disorders
Hematoma
|
2.1%
1/48 • Number of events 1 • 2 years
|
0.00%
0/22 • 2 years
|
|
Vascular disorders
Hypertension
|
4.2%
2/48 • Number of events 2 • 2 years
|
0.00%
0/22 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
2.1%
1/48 • Number of events 1 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
PAZOPANIB
n=48 participants at risk
Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
PAZOPANIB treatment: Pazopanib
* 800 mg per day
* oral administration
* at least 1 hour before or 2 hours after a meal,
* until disease progression or for 12 months maximum
|
Vinblastine and Methotrexate
n=22 participants at risk
vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
Active Comparator: Vinblastine and Methotrexate: Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
2/48 • Number of events 2 • 2 years
|
22.7%
5/22 • Number of events 7 • 2 years
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
12/48 • Number of events 13 • 2 years
|
0.00%
0/22 • 2 years
|
|
Endocrine disorders
Eye disorders - Other, specify
|
14.6%
7/48 • Number of events 8 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
16/48 • Number of events 29 • 2 years
|
27.3%
6/22 • Number of events 6 • 2 years
|
|
Gastrointestinal disorders
Bloating
|
8.3%
4/48 • Number of events 4 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
12.5%
6/48 • Number of events 6 • 2 years
|
54.5%
12/22 • Number of events 15 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
77.1%
37/48 • Number of events 60 • 2 years
|
40.9%
9/22 • Number of events 10 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
4/48 • Number of events 4 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.1%
1/48 • Number of events 1 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
18.8%
9/48 • Number of events 12 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
16.7%
8/48 • Number of events 9 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
27.1%
13/48 • Number of events 17 • 2 years
|
31.8%
7/22 • Number of events 11 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
54.2%
26/48 • Number of events 34 • 2 years
|
72.7%
16/22 • Number of events 19 • 2 years
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/48 • 2 years
|
18.2%
4/22 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Toothache
|
6.2%
3/48 • Number of events 3 • 2 years
|
4.5%
1/22 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
31.2%
15/48 • Number of events 24 • 2 years
|
27.3%
6/22 • Number of events 6 • 2 years
|
|
General disorders
Edema limbs
|
6.2%
3/48 • Number of events 3 • 2 years
|
4.5%
1/22 • Number of events 2 • 2 years
|
|
General disorders
Fatigue
|
83.3%
40/48 • Number of events 45 • 2 years
|
68.2%
15/22 • Number of events 19 • 2 years
|
|
General disorders
Fever
|
6.2%
3/48 • Number of events 4 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
General disorders
Flu like symptoms
|
6.2%
3/48 • Number of events 3 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
4.2%
2/48 • Number of events 2 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
General disorders
Pain
|
8.3%
4/48 • Number of events 4 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
16.7%
8/48 • Number of events 9 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Infections and infestations
Tooth infection
|
8.3%
4/48 • Number of events 4 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Infections and infestations
Urinary tract infection
|
6.2%
3/48 • Number of events 5 • 2 years
|
0.00%
0/22 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
31.2%
15/48 • Number of events 16 • 2 years
|
31.8%
7/22 • Number of events 8 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
12/48 • Number of events 12 • 2 years
|
18.2%
4/22 • Number of events 4 • 2 years
|
|
Investigations
Blood bilirubin increased
|
6.2%
3/48 • Number of events 3 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
Investigations
GGT increased
|
6.2%
3/48 • Number of events 8 • 2 years
|
13.6%
3/22 • Number of events 3 • 2 years
|
|
Investigations
Investigations - Other, specify
|
12.5%
6/48 • Number of events 8 • 2 years
|
0.00%
0/22 • 2 years
|
|
Investigations
Neutrophil count decreased
|
8.3%
4/48 • Number of events 5 • 2 years
|
45.5%
10/22 • Number of events 14 • 2 years
|
|
Investigations
Platelet count decreased
|
10.4%
5/48 • Number of events 6 • 2 years
|
0.00%
0/22 • 2 years
|
|
Investigations
Weight loss
|
10.4%
5/48 • Number of events 6 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
35.4%
17/48 • Number of events 21 • 2 years
|
22.7%
5/22 • Number of events 5 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
3/48 • Number of events 3 • 2 years
|
0.00%
0/22 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.1%
13/48 • Number of events 17 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.8%
10/48 • Number of events 11 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
12.5%
6/48 • Number of events 6 • 2 years
|
18.2%
4/22 • Number of events 7 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
8/48 • Number of events 9 • 2 years
|
22.7%
5/22 • Number of events 6 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
12.5%
6/48 • Number of events 6 • 2 years
|
0.00%
0/22 • 2 years
|
|
Nervous system disorders
Dysesthesia
|
4.2%
2/48 • Number of events 2 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
27.1%
13/48 • Number of events 13 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Nervous system disorders
Headache
|
43.8%
21/48 • Number of events 32 • 2 years
|
18.2%
4/22 • Number of events 5 • 2 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/48 • 2 years
|
9.1%
2/22 • Number of events 2 • 2 years
|
|
Nervous system disorders
Paresthesia
|
4.2%
2/48 • Number of events 2 • 2 years
|
27.3%
6/22 • Number of events 6 • 2 years
|
|
Psychiatric disorders
Anxiety
|
8.3%
4/48 • Number of events 4 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Insomnia
|
10.4%
5/48 • Number of events 6 • 2 years
|
4.5%
1/22 • Number of events 1 • 2 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
8.3%
4/48 • Number of events 4 • 2 years
|
0.00%
0/22 • 2 years
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
6.2%
3/48 • Number of events 4 • 2 years
|
0.00%
0/22 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
4/48 • Number of events 4 • 2 years
|
0.00%
0/22 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
4/48 • Number of events 4 • 2 years
|
0.00%
0/22 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
6.2%
3/48 • Number of events 3 • 2 years
|
0.00%
0/22 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
6/48 • Number of events 6 • 2 years
|
18.2%
4/22 • Number of events 4 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.6%
7/48 • Number of events 8 • 2 years
|
0.00%
0/22 • 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
33.3%
16/48 • Number of events 22 • 2 years
|
0.00%
0/22 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
4/48 • Number of events 4 • 2 years
|
4.5%
1/22 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
75.0%
36/48 • Number of events 50 • 2 years
|
13.6%
3/22 • Number of events 3 • 2 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
20.8%
10/48 • Number of events 10 • 2 years
|
0.00%
0/22 • 2 years
|
|
Vascular disorders
Hot flashes
|
10.4%
5/48 • Number of events 5 • 2 years
|
0.00%
0/22 • 2 years
|
|
Vascular disorders
Hypertension
|
45.8%
22/48 • Number of events 27 • 2 years
|
0.00%
0/22 • 2 years
|
Additional Information
Pr Antoine Italiano, coordinating investigator
Department of Medical Oncology, Institut bergonié
Phone: 05.47.30.60.88
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place