Trial Outcomes & Findings for Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer (NCT NCT00718809)
NCT ID: NCT00718809
Last Updated: 2015-06-10
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by 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. The objective response rate will be reported by each disease classification. The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. Note: there were no objective responses in this trial.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2015-06-10
Participant Flow
This protocol was based on getting at least 12 eligible patients with thymoma to complete stage one. There are 12 eligible thymoma patients and also 9 thymic carcinoma patients. Since no patients in the thymoma group had a response of Complete or Partial response, the study ended without going to stage two.
Participant milestones
| Measure |
Thymoma
Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Thymic Carcinoma
Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
9
|
Reasons for withdrawal
| Measure |
Thymoma
Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Thymic Carcinoma
Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Disease progression
|
9
|
7
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Noncompliance
|
1
|
0
|
Baseline Characteristics
Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer
Baseline characteristics by cohort
| Measure |
Thymoma
n=12 Participants
Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Thymic Carcinoma
n=9 Participants
Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 12.25 • n=39 Participants
|
54.2 years
STANDARD_DEVIATION 17.94 • n=41 Participants
|
51.3 years
STANDARD_DEVIATION 14.76 • n=35 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: All patients with at least one post baseline measurement.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by 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. The objective response rate will be reported by each disease classification. The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug. Note: there were no objective responses in this trial.
Outcome measures
| Measure |
Thymoma
n=12 Participants
Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Thymic Carcinoma
n=9 Participants
Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Objective Response Rate (Complete and Partial Response)
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Time from the date of registration to the first reported outcome event, assessed up to 5 yearsPopulation: All patients who enrolled and received treatment.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 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. This will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.
Outcome measures
| Measure |
Thymoma
n=12 Participants
Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Thymic Carcinoma
n=9 Participants
Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival
|
5.30 months
Interval 1.74 to 7.8
|
0.89 months
Interval 0.86 to 3.95
|
SECONDARY outcome
Timeframe: Time from the date of registration to last reported date of survival, assessed up to 5 yearsPopulation: All patients who enrolled and received treatment
Will be examined in an exploratory fashion using Kaplan-Meier estimates. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis.
Outcome measures
| Measure |
Thymoma
n=12 Participants
Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Thymic Carcinoma
n=9 Participants
Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival
|
37.47 months
Interval 12.27 to
The upper confidence interval is not estimable for overall survival in this group due to insufficient number of participants with events.
|
6.68 months
Interval 2.47 to 14.97
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All patients who enrolled and received treatment
Will be examined in an exploratory fashion using Kaplan-Meier estimates. Disease control rate defined as complete response (CR) + partial response (PR) + stable disease (SD). The length of time until progression or until last evaluation will be calculated. For patients who did not progress, they will be censored in the analysis.
Outcome measures
| Measure |
Thymoma
n=12 Participants
Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Thymic Carcinoma
n=9 Participants
Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Disease Control Rate
|
5.72 months
Interval 1.84 to 7.8
|
3.55 months
The upper and lower confidence intervals could not be estimated for this group due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All patients
Number of patients who had toxicities classified as skin rashes and diarrhea within the adverse events.
Outcome measures
| Measure |
Thymoma
n=12 Participants
Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Thymic Carcinoma
n=9 Participants
Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Expected Toxicities Including Skin Rashes and Diarrhea
|
10 participants
|
3 participants
|
Adverse Events
Thymoma
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Thymic Carcinoma
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Thymoma
n=12 participants at risk
Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Thymic Carcinoma
n=9 participants at risk
Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
VOMITING
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Investigations
Unexpected Change in HEMOGLOBIN level
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Metabolism and nutrition disorders
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Vascular disorders
CNS CEREBROVASCULAR ISCHEMIA
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Vascular disorders
VESSEL INJURY-VEIN - SVC
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
Other adverse events
| Measure |
Thymoma
n=12 participants at risk
Patients classified as having Thymoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Thymic Carcinoma
n=9 participants at risk
Patients classified as having Thymic carcinoma. Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Blood and lymphatic system disorders
HEMOLYSIS (E.G., IMMUNE HEMOLYTIC ANEMIA, DRUG-RELATED HEMOLYSIS)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
25.0%
3/12 • Number of events 3 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Cardiac disorders
MYOCARDITIS
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA - SINUS TACHYCARDIA
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Nervous system disorders
COGNITIVE DISTURBANCE
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Eye disorders
OCULAR/VISUAL
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Eye disorders
VISION-BLURRED VISION
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
ASCITES (NON-MALIGNANT)
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
33.3%
4/12 • Number of events 4 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
DIARRHEA
|
50.0%
6/12 • Number of events 6 • Beginning of treatment until the end of the study, up to 5 years
|
33.3%
3/9 • Number of events 3 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
DISTENSION/BLOATING, ABDOMINAL
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
GASTRITIS (INCLUDING BILE REFLUX GASTRITIS)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
33.3%
4/12 • Number of events 4 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
HEMORRHAGE, GI - ANUS
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
NAUSEA
|
91.7%
11/12 • Number of events 11 • Beginning of treatment until the end of the study, up to 5 years
|
33.3%
3/9 • Number of events 3 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
PAIN - ABDOMEN NOS
|
33.3%
4/12 • Number of events 4 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
25.0%
3/12 • Number of events 3 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Gastrointestinal disorders
VOMITING
|
50.0%
6/12 • Number of events 6 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
22.2%
2/9 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
|
General disorders
DYSPNEA (SHORTNESS OF BREATH)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
General disorders
EDEMA: HEAD AND NECK
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
General disorders
EDEMA: LIMB
|
16.7%
2/12 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
75.0%
9/12 • Number of events 9 • Beginning of treatment until the end of the study, up to 5 years
|
77.8%
7/9 • Number of events 7 • Beginning of treatment until the end of the study, up to 5 years
|
|
General disorders
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN)
|
25.0%
3/12 • Number of events 3 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
General disorders
PAIN - CHEST/THORAX NOS
|
33.3%
4/12 • Number of events 4 • Beginning of treatment until the end of the study, up to 5 years
|
22.2%
2/9 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
|
General disorders
PAIN - OTHER
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
22.2%
2/9 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
|
General disorders
RIGORS/CHILLS
|
25.0%
3/12 • Number of events 3 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
General disorders
SWEATING (DIAPHORESIS)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Infections and infestations
INFECTION - OTHER
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - ORAL CAVITY-GUMS (GINGIVITIS)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - ORAL CAVITY-GUMS (GINGIVITIS)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Investigations
ALKALINE PHOSPHATASE
|
16.7%
2/12 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
33.3%
3/9 • Number of events 3 • Beginning of treatment until the end of the study, up to 5 years
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
16.7%
2/12 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
25.0%
3/12 • Number of events 3 • Beginning of treatment until the end of the study, up to 5 years
|
22.2%
2/9 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
|
Investigations
BICARBONATE, SERUM-LOW
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Investigations
CREATININE
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Investigations
HEMOGLOBIN
|
25.0%
3/12 • Number of events 3 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Investigations
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - TRACHEA
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Investigations
NEUTROPHILS/GRANULOCYTES (ANC/AGC)
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Investigations
WEIGHT LOSS
|
16.7%
2/12 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
22.2%
2/9 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
|
Metabolism and nutrition disorders
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
22.2%
2/9 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
|
Metabolism and nutrition disorders
ANOREXIA
|
58.3%
7/12 • Number of events 7 • Beginning of treatment until the end of the study, up to 5 years
|
44.4%
4/9 • Number of events 4 • Beginning of treatment until the end of the study, up to 5 years
|
|
Metabolism and nutrition disorders
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Metabolism and nutrition disorders
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Metabolism and nutrition disorders
PHOSPHATE, SERUM-LOW (HYPOPHOSPHATEMIA)
|
33.3%
4/12 • Number of events 4 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Metabolism and nutrition disorders
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
16.7%
2/12 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Metabolism and nutrition disorders
SODIUM, SERUM-LOW (HYPONATREMIA)
|
33.3%
4/12 • Number of events 4 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - BACK
|
33.3%
4/12 • Number of events 4 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - EXTREMITY-LIMB
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
22.2%
2/9 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - JOINT
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN - MUSCLE
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Nervous system disorders
DIZZINESS
|
33.3%
4/12 • Number of events 4 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Nervous system disorders
INSOMNIA
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Nervous system disorders
PAIN - HEAD/HEADACHE
|
16.7%
2/12 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Nervous system disorders
SOMNOLENCE/DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Nervous system disorders
SYNCOPE (FAINTING)
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Psychiatric disorders
INSOMNIA
|
16.7%
2/12 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Psychiatric disorders
MENTAL STATUS
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Psychiatric disorders
MOOD ALTERATION - ANXIETY
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Psychiatric disorders
MOOD ALTERATION - DEPRESSION
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Renal and urinary disorders
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Renal and urinary disorders
PAIN - URETHRA
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Renal and urinary disorders
PROTEINURIA
|
25.0%
3/12 • Number of events 3 • Beginning of treatment until the end of the study, up to 5 years
|
22.2%
2/9 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
|
Renal and urinary disorders
RENAL/GENITOURINARY - OTHER
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Reproductive system and breast disorders
PAIN - BREAST
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Reproductive system and breast disorders
PAIN - VAGINA
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - RESPIRATORY TRACT NOS
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM, WHEEZING
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
66.7%
8/12 • Number of events 8 • Beginning of treatment until the end of the study, up to 5 years
|
22.2%
2/9 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
50.0%
6/12 • Number of events 6 • Beginning of treatment until the end of the study, up to 5 years
|
55.6%
5/9 • Number of events 5 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - LUNG
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CAVITY/PARANASAL SINUS REACTIONS
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PAIN - SINUS
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS/PULMONARY INFILTRATES
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER
|
16.7%
2/12 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
16.7%
2/12 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
25.0%
3/12 • Number of events 3 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
16.7%
2/12 • Number of events 2 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
33.3%
4/12 • Number of events 4 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
SWEATING (DIAPHORESIS)
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/12 • Beginning of treatment until the end of the study, up to 5 years
|
11.1%
1/9 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
8.3%
1/12 • Number of events 1 • Beginning of treatment until the end of the study, up to 5 years
|
0.00%
0/9 • Beginning of treatment until the end of the study, up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60