Trial Outcomes & Findings for RAD001 in Recurrent Endometrial Cancer Patients (NCT NCT00087685)
NCT ID: NCT00087685
Last Updated: 2025-05-01
Results Overview
Response determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Stable Disease (SD): Any condition not meeting the above criteria. The minimum duration for the SD will be 8 weeks. If the participant has stable disease at the time of the first radiographic evaluation, he/she will be considered to have stable disease. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-05-01
Participant Flow
Recruitment Period: June 18, 2004 to March 20, 2008. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
RAD001
10 mg orally daily/28-day cycles
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
RAD001
10 mg orally daily/28-day cycles
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Non-Compliance
|
1
|
|
Overall Study
Progressive Disease
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
RAD001 in Recurrent Endometrial Cancer Patients
Baseline characteristics by cohort
| Measure |
RAD001
n=35 Participants
10 mg orally daily/28-day cycles
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Of the 35 participants, four (4) were inevaluable due to inadequate treatment on trial.
Response determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Stable Disease (SD): Any condition not meeting the above criteria. The minimum duration for the SD will be 8 weeks. If the participant has stable disease at the time of the first radiographic evaluation, he/she will be considered to have stable disease. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.
Outcome measures
| Measure |
RAD001
n=31 Participants
10 mg orally daily/28-day cycles
|
|---|---|
|
Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD)
Complete Response (CR)
|
0 participants
|
|
Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD)
Partial Response (PD)
|
0 participants
|
|
Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD)
Stable Disease (SD)
|
14 participants
|
|
Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD)
Progressive Disease (PD)
|
17 participants
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: Of the 35 participants, four (4) were inevaluable due to inadequate treatment on trial.
Clinical benefit rate (CBR) is defined as the objective response rate plus the proportion of participants with prolonged stable disease (SD), e.g. nonprogression at 20 weeks. Objective response rate (ORR), determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST).
Outcome measures
| Measure |
RAD001
n=31 Participants
10 mg orally daily/28-day cycles
|
|---|---|
|
Clinical Benefit Rate
|
21 percentage of participants
Interval 8.3 to 41.0
|
Adverse Events
RAD001
Serious events: 25 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RAD001
n=35 participants at risk
10 mg orally daily/28-day cycles
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.7%
2/35 • Number of events 2 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.7%
2/35 • Number of events 2 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Fatigue
|
5.7%
2/35 • Number of events 2 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Anorexia
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Asthenia
|
5.7%
2/35 • Number of events 2 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Renal and urinary disorders
Cystitis
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Blood and lymphatic system disorders
Decreased Platelets
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Blood and lymphatic system disorders
Decreased Hemoglobin
|
5.7%
2/35 • Number of events 2 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Death
|
34.3%
12/35 • Number of events 12 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.6%
3/35 • Number of events 3 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Pain
|
8.6%
3/35 • Number of events 3 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
5/35 • Number of events 5 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Nausea
|
17.1%
6/35 • Number of events 6 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
6/35 • Number of events 6 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Dehydration
|
5.7%
2/35 • Number of events 2 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Fever
|
14.3%
5/35 • Number of events 5 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Fever Non-Neutropenic
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Nervous system disorders
Confusion
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.7%
2/35 • Number of events 2 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Infections and infestations
Pneumonitis
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Ileus
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Nervous system disorders
Syncope
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Cardiac disorders
Palpitations
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Mass
|
8.6%
3/35 • Number of events 3 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Nervous system disorders
Dizziness
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Nervous system disorders
Headache
|
5.7%
2/35 • Number of events 2 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.9%
1/35 • Number of events 1 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Infections and infestations
Mucositis
|
28.6%
10/35 • Number of events 10 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
5.7%
2/35 • Number of events 2 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
2/35 • Number of events 2 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
Other adverse events
| Measure |
RAD001
n=35 participants at risk
10 mg orally daily/28-day cycles
|
|---|---|
|
Metabolism and nutrition disorders
Alkaline Phosphatase Elevated
|
20.0%
7/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.6%
3/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
22.9%
8/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Anorexia
|
54.3%
19/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
AST, SGOT
|
28.6%
10/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Bilirubin
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Eye disorders
Blurred Vision
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Cholesterol, Serum-High
|
60.0%
21/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Constipation
|
37.1%
13/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
5/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Creatinine
|
5.7%
2/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
8.6%
3/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Diaphoresis
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Diarrhea
|
22.9%
8/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Distension/Bloating
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Nervous system disorders
Dizziness
|
5.7%
2/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.7%
9/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Blood and lymphatic system disorders
Edema: Head and Neck
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Elevated LDH
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Fatigue
|
74.3%
26/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Fever Without Neutropenia
|
11.4%
4/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Gastrointestinal
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Ear and labyrinth disorders
Hearing
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Heartburn
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hemoglobin
|
62.9%
22/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Endocrine disorders
Hot Flashes
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
42.9%
15/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Cardiac disorders
Hypertension
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
65.7%
23/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.4%
4/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.7%
9/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.4%
4/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Blood and lymphatic system disorders
INR
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Nervous system disorders
Insomnia
|
5.7%
2/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Blood and lymphatic system disorders
Leukocytes
|
54.3%
19/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
42.9%
15/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Nervous system disorders
Memory Impairment
|
5.7%
2/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory
|
60.0%
21/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Nervous system disorders
Mood Alteration
|
25.7%
9/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Mucositis, Oral Cavity
|
17.1%
6/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
11.4%
4/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Nausea
|
68.6%
24/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Nervous system disorders
Neuropathy, Sensory
|
28.6%
10/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Blood and lymphatic system disorders
Neutrophils
|
31.4%
11/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Pain (Abdomen NOS)
|
8.6%
3/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Musculoskeletal and connective tissue disorders
Pain (Back)
|
8.6%
3/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Musculoskeletal and connective tissue disorders
Pain (Bone)
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Musculoskeletal and connective tissue disorders
Pain (Breast)
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Musculoskeletal and connective tissue disorders
Pain (Buttock)
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Musculoskeletal and connective tissue disorders
Pain (Extremity - Limb)
|
5.7%
2/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Nervous system disorders
Pain (Head)
|
28.6%
10/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Musculoskeletal and connective tissue disorders
Pain (Joint)
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Musculoskeletal and connective tissue disorders
Pain (Muscle)
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Pain (NOS)
|
11.4%
4/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Pain (Oral Cavity)
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Musculoskeletal and connective tissue disorders
Pain (Pelvis)
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Skin and subcutaneous tissue disorders
Pain (Skin)
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Cardiac disorders
Palpitations
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Blood and lymphatic system disorders
Platelet Increase
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Blood and lymphatic system disorders
Platelet Decrease
|
34.3%
12/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
2/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
22.9%
8/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Rhinorrhea
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Rigors/Chills
|
17.1%
6/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Nervous system disorders
Somnolence
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Sore Throat
|
5.7%
2/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Sweating
|
8.6%
3/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Taste Alteration
|
11.4%
4/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Ear and labyrinth disorders
Tinnitus
|
2.9%
1/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Gastrointestinal disorders
Vomiting
|
34.3%
12/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
General disorders
Weight Loss
|
22.9%
8/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.7%
2/35 • Adverse events (AEs) collected on average every 4 weeks during clinical evaluation from the start of treatment until discontinuation of treatment. Overall AE collection period: July 12, 2004 to August 07, 2008.
|
Additional Information
Karen H. Lu, MD, Chair, Gynecologic Oncology & Reproductive Medicine
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-745-8902
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place