Trial Outcomes & Findings for BAY43-9006 - Phase II in Advanced Breast Cancer (NCT NCT00101400)
NCT ID: NCT00101400
Last Updated: 2013-12-13
Results Overview
Number of subjects with metastatic breast cancer treated with single agent BAY43-9006 who had best overall response assessed as complete response (CR) or partial response (PR) as per Modified World Health Organization (WHO) Tumor Response Criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Until 30 days after termination of active therapy
Results posted on
2013-12-13
Participant Flow
Subjects were enrolled from 03 Feb 2004 to 29 Jul 2004 by 3 centers in Germany and 4 centers in Italy.
2 subjects were excluded during screening phase: 1 withdrawal of consent and 1 protocol violation.
Participant milestones
| Measure |
Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg administered twice daily (b.i.d.)
|
|---|---|
|
Treatment
STARTED
|
54
|
|
Treatment
COMPLETED
|
54
|
|
Treatment
NOT COMPLETED
|
0
|
|
Survival Follow-Up
STARTED
|
51
|
|
Survival Follow-Up
COMPLETED
|
44
|
|
Survival Follow-Up
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg administered twice daily (b.i.d.)
|
|---|---|
|
Survival Follow-Up
Alive
|
7
|
Baseline Characteristics
BAY43-9006 - Phase II in Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=54 Participants
Sorafenib 400 mg administered twice daily (b.i.d.)
|
|---|---|
|
Age Continuous
|
55.4 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 0: fully active
|
30 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 1: Restricted strenous activity, ambulatory
|
22 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 2: Ambulatory, difficulty in walking
|
2 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 3: Limited self-care, partly confined to bed
|
0 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 4: Completely disabled, no self-care
|
0 participants
n=5 Participants
|
|
Stage of disease at study entry (Tumor, Nodules, Metastasis (TNM) classification)
Stage I
|
0 participants
n=5 Participants
|
|
Stage of disease at study entry (Tumor, Nodules, Metastasis (TNM) classification)
Stage II
|
0 participants
n=5 Participants
|
|
Stage of disease at study entry (Tumor, Nodules, Metastasis (TNM) classification)
Stage III
|
0 participants
n=5 Participants
|
|
Stage of disease at study entry (Tumor, Nodules, Metastasis (TNM) classification)
Stage IV -most advanced
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until 30 days after termination of active therapyPopulation: Intent to treat population consisted of subjects who received at least 1 dose of sorafenib.
Number of subjects with metastatic breast cancer treated with single agent BAY43-9006 who had best overall response assessed as complete response (CR) or partial response (PR) as per Modified World Health Organization (WHO) Tumor Response Criteria.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=54 Participants
Sorafenib 400 mg administered twice daily (b.i.d.)
|
|---|---|
|
Number of Subjects With Response (Complete or Partial)
Complete response (CR)
|
0 participants
|
|
Number of Subjects With Response (Complete or Partial)
Partial response (PR)
|
1 participants
|
|
Number of Subjects With Response (Complete or Partial)
Stable disease (SD)
|
20 participants
|
|
Number of Subjects With Response (Complete or Partial)
Progressive disease (PD)
|
31 participants
|
|
Number of Subjects With Response (Complete or Partial)
Not evaluated
|
2 participants
|
SECONDARY outcome
Timeframe: Until progression occursPopulation: Of the intent to treat population, 4 subjects died before assessment of progression; for 1 subject the progression date not available; and 1 subject was lost to follow-up.
Time from start of treatment until progression was first documented.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=48 Participants
Sorafenib 400 mg administered twice daily (b.i.d.)
|
|---|---|
|
Time to Progression
|
58 days
Interval 52.0 to 112.0
|
SECONDARY outcome
Timeframe: Until objective response occursPopulation: 1 subject out of 54 achieved PR.
Defined only for subjects achieving objective tumor response from start of treatment to the date when confirmed PR or CR was first documented according to the Modified WHO Tumor Response Criteria.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=1 Participants
Sorafenib 400 mg administered twice daily (b.i.d.)
|
|---|---|
|
Time to Objective Response
|
145 days
|
SECONDARY outcome
Timeframe: Time from PR or CR to progressionPopulation: 1 subject out of 54 achieved PR.
Overall response duration was defined only for subjects achieving confirmed objective response (PR or CR). It was measured from start of treatment to the date when progressive disease was first objectively documented.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=1 Participants
Sorafenib 400 mg administered twice daily (b.i.d.)
|
|---|---|
|
Overall Response Duration
|
256 days
|
SECONDARY outcome
Timeframe: Start of treatment to deathPopulation: Intent to treat population consisting of subjects who received at least 1 dose of sorafenib.
After the end of treatment visit (30 days after the last dose), the subjects were monitored every 3 months for survival (visits/phone calls).
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=54 Participants
Sorafenib 400 mg administered twice daily (b.i.d.)
|
|---|---|
|
Survival Time
|
259 days
Interval 177.0 to 323.0
|
SECONDARY outcome
Timeframe: Until 30 days after termination of active therapyPopulation: Intent to treat population consisting of subjects who received at least 1 dose of sorafenib.
Number of subjects who had not responded to treatment but had stable disease up to cycle 4.
Outcome measures
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=54 Participants
Sorafenib 400 mg administered twice daily (b.i.d.)
|
|---|---|
|
Number of Subjects With Stable Disease up to Cycle 4
|
12 participants
|
Adverse Events
Sorafenib (Nexavar, BAY43-9006)
Serious events: 22 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=54 participants at risk
Sorafenib 400 mg administered twice daily (b.i.d.)
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Blood and lymphatic system disorders
Coagulation - Other
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Cardiac disorders
Supraventricular Arrhythmia, Supraventricular Tachycardia
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Cardiac disorders
Cardiac General - Other
|
3.7%
2/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Gastrointestinal disorders
Anorexia
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Gastrointestinal disorders
Ascites
|
3.7%
2/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Gastrointestinal disorders
Perforation, GI, Colon
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Death Not Associated With CTCAE Term, Disease Progression NOS
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Fever
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Fatigue
|
13.0%
7/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Pain, Back
|
3.7%
2/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Pain, Chest/Thorax NOS
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Pain, Abdomen NOS
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Pain, Head/Headache
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Hepatobiliary disorders
Liver Dysfunction
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Hepatobiliary disorders
Hepatobiliary - Other
|
3.7%
2/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Metabolism and nutrition disorders
Bilirubin (Hyperbilirubinemia)
|
3.7%
2/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Nervous system disorders
Dizziness
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Nervous system disorders
Neuropathy: Motor
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Nervous system disorders
CNS Necrosis
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Nervous system disorders
Neurology - Other
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Renal and urinary disorders
Renal Failure
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.7%
2/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Shortness Of Breath)
|
13.0%
7/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
1.9%
1/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
Other adverse events
| Measure |
Sorafenib (Nexavar, BAY43-9006)
n=54 participants at risk
Sorafenib 400 mg administered twice daily (b.i.d.)
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophils
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Blood and lymphatic system disorders
Hemoglobin
|
9.3%
5/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Blood and lymphatic system disorders
Platelets
|
9.3%
5/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Blood and lymphatic system disorders
Leukocytes
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Blood and lymphatic system disorders
Dermal Change
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Blood and lymphatic system disorders
Edema: Limb
|
13.0%
7/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Cardiac disorders
Hypertension
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Cardiac disorders
Cardiac General - Other
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Gastrointestinal disorders
Anorexia
|
53.7%
29/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Gastrointestinal disorders
Constipation
|
24.1%
13/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Gastrointestinal disorders
Diarrhea
|
25.9%
14/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Gastrointestinal disorders
Dysphagia
|
13.0%
7/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Gastrointestinal disorders
Gastritis
|
16.7%
9/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam), Oral Cavity
|
14.8%
8/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Gastrointestinal disorders
Nausea
|
35.2%
19/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Gastrointestinal disorders
Vomiting
|
20.4%
11/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Fever
|
13.0%
7/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Insomnia
|
11.1%
6/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Fatigue
|
50.0%
27/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Weight Loss
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Constitutional Symptoms - Other
|
9.3%
5/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Pain, Back
|
7.4%
4/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Pain, Extremity - Limb
|
7.4%
4/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Pain, Abdomen NOS
|
16.7%
9/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Pain, Head/Headache
|
11.1%
6/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Pain, Joint
|
7.4%
4/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Pain, Bone
|
16.7%
9/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Pain, Other
|
29.6%
16/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Pain, Liver
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
General disorders
Pain, Stomach
|
11.1%
6/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Hepatobiliary disorders
Hepatobiliary - Other
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Infections and infestations
Infection - Other
|
11.1%
6/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
13.0%
7/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Metabolism and nutrition disorders
ALT
|
18.5%
10/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Metabolism and nutrition disorders
AST
|
14.8%
8/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Metabolism and nutrition disorders
GGT
|
13.0%
7/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Metabolism and nutrition disorders
Bilirubin (Hyperbilirubinemia)
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Metabolism and nutrition disorders
Metabolic/Lab - Other
|
9.3%
5/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Nervous system disorders
Mood Alteration, Anxiety
|
7.4%
4/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Nervous system disorders
Confusion
|
7.4%
4/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Nervous system disorders
Dizziness
|
11.1%
6/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Nervous system disorders
Neurology - Other
|
9.3%
5/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Nervous system disorders
Neuropathy: Sensory
|
13.0%
7/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Nervous system disorders
Somnolence
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.4%
11/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
7.4%
4/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (Shortness Of Breath)
|
25.9%
14/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
9/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Skin Reaction
|
24.1%
13/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Skin and subcutaneous tissue disorders
Dermatology - Other
|
13.0%
7/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.8%
15/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
38.9%
21/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Skin and subcutaneous tissue disorders
Flushing
|
7.4%
4/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
|
Vascular disorders
Hemorrhage Pulmonary, Nose
|
5.6%
3/54
Acronyms used: Gastrointestinal (GI), Common Terminology Criteria for Adverse Events (CTCAE), Not Otherwise Specified (NOS), Central nervous system (CNS), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gammaglutamyltransferase (GGT).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60