Trial Outcomes & Findings for Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer (NCT NCT00093145)
NCT ID: NCT00093145
Last Updated: 2019-11-25
Results Overview
Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits.
COMPLETED
PHASE2
32 participants
Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)
2019-11-25
Participant Flow
Due to slow patient accrual, only 32 patients of the planned 50 patients were enrolled. Patients were enrolled between June 2004 and July 2007.
Participant milestones
| Measure |
Albumin-bound Paclitaxel, Carboplatin + Herceptin
Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
At Least One Response Assessment
|
31
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Albumin-bound Paclitaxel, Carboplatin + Herceptin
Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
|
|---|---|
|
Overall Study
Unacceptable Toxicity Only
|
2
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Albumin-bound Paclitaxel, Carboplatin + Herceptin
n=32 Participants
Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
52.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, of African Heritage
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic and Non-Latino
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Hispanic or Latino
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
|
Menopausal Status
Pre-Menopausal
|
7 participants
n=5 Participants
|
|
Menopausal Status
Post-Menopausal
|
25 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 (Fully Active)
|
19 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 (Restrictive but Ambulatory)
|
12 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 (Ambulatory, but Unable to Work)
|
1 participants
n=5 Participants
|
|
Physician assessment of peripheral neuropathy
Grade 0
|
30 participants
n=5 Participants
|
|
Physician assessment of peripheral neuropathy
Grade 1
|
1 participants
n=5 Participants
|
|
Histology of Primary Diagnosis
Carcinoma/Adenocarcinoma
|
31 participants
n=5 Participants
|
|
Histology of Primary Diagnosis
Other
|
1 participants
n=5 Participants
|
|
Time from first documented metastatic disease to study entry
|
0.1 years
n=5 Participants
|
|
Specific site(s) of metastasis/relapse
Brain/Central Nervous System
|
1 participants
n=5 Participants
|
|
Specific site(s) of metastasis/relapse
Skin/Soft Tissue/Breast
|
21 participants
n=5 Participants
|
|
Specific site(s) of metastasis/relapse
Lymph Nodes
|
24 participants
n=5 Participants
|
|
Specific site(s) of metastasis/relapse
Lung
|
19 participants
n=5 Participants
|
|
Specific site(s) of metastasis/relapse
Liver
|
15 participants
n=5 Participants
|
|
Specific site(s) of metastasis/relapse
Peritoneal
|
1 participants
n=5 Participants
|
|
Specific site(s) of metastasis/relapse
Bone
|
22 participants
n=5 Participants
|
|
Specific site(s) of metastasis/relapse
Other
|
1 participants
n=5 Participants
|
|
Dominant site of metastasis/relapse
Visceral
|
24 participants
n=5 Participants
|
|
Dominant site of metastasis/relapse
Non Visceral
|
8 participants
n=5 Participants
|
|
Number of Lesions (Target + Non-Target)
0 or 1 lesion
|
0 participants
n=5 Participants
|
|
Number of Lesions (Target + Non-Target)
2 to 3 lesions
|
10 participants
n=5 Participants
|
|
Number of Lesions (Target + Non-Target)
> 3 lesions
|
22 participants
n=5 Participants
|
|
Dominant Lesion Site (Target + Non-Target)
Visceral
|
25 participants
n=5 Participants
|
|
Dominant Lesion Site (Target + Non-Target)
Non visceral
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)Population: The treated population consisted of all randomized participants who received at least one dose of study drug.
Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
Albumin-bound Paclitaxel, Carboplatin + Herceptin
n=32 Participants
Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
|
|---|---|
|
Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response
|
62.5 Percentage of participants
Interval 45.7 to 79.3
|
SECONDARY outcome
Timeframe: Evaluated every 2 cycles, up to a maximum of 39 cycles.Population: Treated population
Total response was defined as the percentage of participants with stable disease (SD) for ≥ 16 weeks or complete or partial overall response. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progressive disease is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.
Outcome measures
| Measure |
Albumin-bound Paclitaxel, Carboplatin + Herceptin
n=32 Participants
Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
|
|---|---|
|
Percentage of Participants With a Total Response
|
81.3 percentage of participants
Interval 67.7 to 94.8
|
SECONDARY outcome
Timeframe: Assessed every 2 cycles, up to a maximum of 39 cycles.Population: Treated population
Time to disease progression was measured from the date of first dose of study drug to the start of disease progression. Patients who did not have disease progression at the end of follow-up were censored at the last known time that the patient was evaluated for progression. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Time to disease progression was summarized using Kaplan-Meier methods.
Outcome measures
| Measure |
Albumin-bound Paclitaxel, Carboplatin + Herceptin
n=32 Participants
Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
|
|---|---|
|
Time to Disease Progression
|
16.6 months
Interval 7.5 to 26.5
|
SECONDARY outcome
Timeframe: Assessed every 2 cycles, up to a maximum of 39 cycles.Population: Treated Population - Patients with a Confirmed Complete or Partial Overall Response
Duration of response was evaluated by measuring progression-free survival for participants with a complete response or partial response. Progression-free survival was defined as the time from the first dose of study drug to the start of progression or patient death (whichever occurred first). Participants who did not have progression or were still alive were censored at the last known time the patient was progression free. Patients that initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.
Outcome measures
| Measure |
Albumin-bound Paclitaxel, Carboplatin + Herceptin
n=20 Participants
Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
|
|---|---|
|
Duration of Response
|
17.8 months
Interval 15.9 to 37.0
|
SECONDARY outcome
Timeframe: From Day 1 until approximately 44 months.Population: Treated population
Overall survival was defined as the time from the day of randomization to patient death (due to any cause), as assessed by post study follow-up on a monthly basis for 3 months and every 3 months. Participants still alive were censored at the last known time that the patient was alive. Patient survival was estimated using Kaplan-Meier methods.
Outcome measures
| Measure |
Albumin-bound Paclitaxel, Carboplatin + Herceptin
n=32 Participants
Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
|
|---|---|
|
Overall Patient Survival
|
NA months
Overall survival could not be estimated due to the low number of deaths.
|
SECONDARY outcome
Timeframe: Day 1 up to 39 cyclesPopulation: Treated population
A Treatment-emergent AE was any AE that began or worsened after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above
Outcome measures
| Measure |
Albumin-bound Paclitaxel, Carboplatin + Herceptin
n=32 Participants
Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
Number with any treatment emergent AE
|
32 participants
|
|
Number of Participants With Adverse Events (AEs)
Number with any treatment-related AE
|
31 participants
|
|
Number of Participants With Adverse Events (AEs)
Number with any Grade 3/4 TEAE
|
20 participants
|
|
Number of Participants With Adverse Events (AEs)
Number with any serious AE
|
5 participants
|
Adverse Events
Albumin-bound Paclitaxel, Carboplatin + Herceptin
Serious adverse events
| Measure |
Albumin-bound Paclitaxel, Carboplatin + Herceptin
n=32 participants at risk
Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
|
|---|---|
|
Immune system disorders
Hypersensitivity
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32 • Day 1 up to 39 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.1%
1/32 • Day 1 up to 39 months
|
|
Infections and infestations
Catheter site infection
|
3.1%
1/32 • Day 1 up to 39 months
|
|
Psychiatric disorders
Confusional state
|
3.1%
1/32 • Day 1 up to 39 months
|
Other adverse events
| Measure |
Albumin-bound Paclitaxel, Carboplatin + Herceptin
n=32 participants at risk
Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
71.9%
23/32 • Day 1 up to 39 months
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
16/32 • Day 1 up to 39 months
|
|
Gastrointestinal disorders
Diarrhoea
|
43.8%
14/32 • Day 1 up to 39 months
|
|
Gastrointestinal disorders
Constipation
|
34.4%
11/32 • Day 1 up to 39 months
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
8/32 • Day 1 up to 39 months
|
|
Gastrointestinal disorders
Abdominal pain
|
21.9%
7/32 • Day 1 up to 39 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.2%
2/32 • Day 1 up to 39 months
|
|
General disorders
Fatigue
|
84.4%
27/32 • Day 1 up to 39 months
|
|
General disorders
Pyrexia
|
25.0%
8/32 • Day 1 up to 39 months
|
|
General disorders
Pain
|
21.9%
7/32 • Day 1 up to 39 months
|
|
General disorders
Rigors
|
21.9%
7/32 • Day 1 up to 39 months
|
|
General disorders
Mucosal inflammation
|
15.6%
5/32 • Day 1 up to 39 months
|
|
General disorders
Oedema peripheral
|
12.5%
4/32 • Day 1 up to 39 months
|
|
General disorders
Asthenia
|
6.2%
2/32 • Day 1 up to 39 months
|
|
General disorders
Chest pain
|
6.2%
2/32 • Day 1 up to 39 months
|
|
General disorders
Performance status decreased
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
65.6%
21/32 • Day 1 up to 39 months
|
|
Blood and lymphatic system disorders
Anaemia
|
62.5%
20/32 • Day 1 up to 39 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
37.5%
12/32 • Day 1 up to 39 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.6%
5/32 • Day 1 up to 39 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
9.4%
3/32 • Day 1 up to 39 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
43.8%
14/32 • Day 1 up to 39 months
|
|
Nervous system disorders
Headache
|
28.1%
9/32 • Day 1 up to 39 months
|
|
Nervous system disorders
Neuropathy
|
18.8%
6/32 • Day 1 up to 39 months
|
|
Nervous system disorders
Dysgeusia
|
15.6%
5/32 • Day 1 up to 39 months
|
|
Nervous system disorders
Neuropathy peripheral
|
9.4%
3/32 • Day 1 up to 39 months
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.6%
13/32 • Day 1 up to 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
31.2%
10/32 • Day 1 up to 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.1%
9/32 • Day 1 up to 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.4%
3/32 • Day 1 up to 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
8/32 • Day 1 up to 39 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
8/32 • Day 1 up to 39 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.8%
6/32 • Day 1 up to 39 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
4/32 • Day 1 up to 39 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.4%
3/32 • Day 1 up to 39 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Musculoskeletal and connective tissue disorders
Facial pain
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Psychiatric disorders
Insomnia
|
53.1%
17/32 • Day 1 up to 39 months
|
|
Psychiatric disorders
Anxiety
|
28.1%
9/32 • Day 1 up to 39 months
|
|
Psychiatric disorders
Depression
|
18.8%
6/32 • Day 1 up to 39 months
|
|
Investigations
Alanine aminotransferase increased
|
18.8%
6/32 • Day 1 up to 39 months
|
|
Investigations
White blood cell count decreased
|
15.6%
5/32 • Day 1 up to 39 months
|
|
Investigations
Aspartate aminotransferase increased
|
9.4%
3/32 • Day 1 up to 39 months
|
|
Investigations
Weight decreased
|
9.4%
3/32 • Day 1 up to 39 months
|
|
Investigations
White blood cell count
|
9.4%
3/32 • Day 1 up to 39 months
|
|
Investigations
Blood creatinine abnormal
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Investigations
Haemoglobin decreased
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Investigations
Platelet count decreased
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
43.8%
14/32 • Day 1 up to 39 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.1%
9/32 • Day 1 up to 39 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Infections and infestations
Upper respiratory tract infection
|
15.6%
5/32 • Day 1 up to 39 months
|
|
Infections and infestations
Urinary tract infection
|
12.5%
4/32 • Day 1 up to 39 months
|
|
Infections and infestations
Infection
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Infections and infestations
Sinusitis
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
4/32 • Day 1 up to 39 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
4/32 • Day 1 up to 39 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.4%
3/32 • Day 1 up to 39 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Immune system disorders
Hypersensitivity
|
9.4%
3/32 • Day 1 up to 39 months
|
|
Immune system disorders
Drug hypersensitivity
|
12.5%
4/32 • Day 1 up to 39 months
|
|
Vascular disorders
Hypertension
|
12.5%
4/32 • Day 1 up to 39 months
|
|
Vascular disorders
Lymphoedema
|
9.4%
3/32 • Day 1 up to 39 months
|
|
Renal and urinary disorders
Dysuria
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Renal and urinary disorders
Haematuria
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Eye disorders
Vision blurred
|
12.5%
4/32 • Day 1 up to 39 months
|
|
Reproductive system and breast disorders
Breast pain
|
9.4%
3/32 • Day 1 up to 39 months
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
2/32 • Day 1 up to 39 months
|
|
Cardiac disorders
Tachycardia
|
6.2%
2/32 • Day 1 up to 39 months
|
Additional Information
Associate Director, Clinical Trials Disclosure
Celgene Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee Institution may publish the results of its findings if a multicenter publication is not forthcoming within 18 months after study completion. Institution shall provide Sponsor a copy of the manuscript at least 30 days prior to submission; if no response is received within 30 days the publication or presentation may proceed without delay. Sponsor may request that Confidential Information be deleted. Publication may be delayed for an additional 60 days if patentable matter is included.
- Publication restrictions are in place
Restriction type: OTHER