Trial Outcomes & Findings for Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia (NCT NCT00096018)
NCT ID: NCT00096018
Last Updated: 2013-10-24
Results Overview
Criteria for response were based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response, which includes clinical, hematologic, and bone marrow features (Cheson, B.D., et al., National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-97.)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
43 participants
Primary outcome timeframe
4 weeks, every 3 months for 2 years, and then every 4 months for 2 years
Results posted on
2013-10-24
Participant Flow
Study Activated: 3/21/2002. Study Closed: 11/19/2010
Participant milestones
| Measure |
Phase I - Dose Escalation
Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
Phase II
Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
30
|
|
Overall Study
Treated With Study Therapy
|
13
|
25
|
|
Overall Study
COMPLETED
|
11
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
14
|
Reasons for withdrawal
| Measure |
Phase I - Dose Escalation
Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
Phase II
Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
|---|---|---|
|
Overall Study
Became Ineligible (not treated)
|
0
|
3
|
|
Overall Study
Miscellaneous (not treated)
|
0
|
2
|
|
Overall Study
Adverse Event
|
0
|
5
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Miscellaneous
|
2
|
1
|
Baseline Characteristics
Fludarabine and Thalidomide in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Phase I - Dose Escalation
n=13 Participants
Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
Phase II
n=25 Participants
Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
30 - 39 years
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Age, Customized
40 - 49 years
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Age, Customized
50 - 59 years
|
2 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Age, Customized
60 - 69 years
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Age, Customized
70 - 79 years
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
25 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks, every 3 months for 2 years, and then every 4 months for 2 yearsPopulation: All Treated Patients
Criteria for response were based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response, which includes clinical, hematologic, and bone marrow features (Cheson, B.D., et al., National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-97.)
Outcome measures
| Measure |
Phase I - Dose Escalation
n=13 Participants
Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
Phase II
n=25 Participants
Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
|---|---|---|
|
Overall Responders (Complete and Partial Response)
|
8 participants
|
18 participants
|
PRIMARY outcome
Timeframe: 4 weeks, every 3 months for 2 years, and then every 4 months for 2 yearsPopulation: Patients with Complete or Partial Response
Outcome measures
| Measure |
Phase I - Dose Escalation
n=8 Participants
Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
Phase II
n=18 Participants
Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
|---|---|---|
|
Duration of Response
|
43.3 months
Standard Deviation 11.3
|
30.0 months
Standard Deviation 16.4
|
Adverse Events
Phase I - Dose Escalation
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase II
Serious events: 15 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I - Dose Escalation
n=13 participants at risk
Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
Phase II
n=25 participants at risk
Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia - Grade 4
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia - Grade 2
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Febrile neutropenia - Grade 3
|
15.4%
2/13 • Number of events 2
|
12.0%
3/25 • Number of events 3
|
|
Blood and lymphatic system disorders
Febrile neutropenia - Grade 4
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 4
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 4
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Cardiac disorders
Angina pectoris - Grade 4
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Death - Grade 5
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Fatigue - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Fatigue - Grade 3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
General disorders
Oedema peripheral - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Pyrexia - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Immune system disorders
Hypersensitivity - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Pneumonia - Grade 3
|
0.00%
0/13
|
12.0%
3/25 • Number of events 3
|
|
Infections and infestations
Upper respiratory tract infection - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection - Grade 3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Femur fracture - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Liver function test abnormal - Grade 4
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Decreased appetite - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Failure to thrive - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour lysis syndrome - Grade 3
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Nervous system disorders
Dysgeusia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion - Grade 3
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism - Grade 3
|
7.7%
1/13 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 3
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash erythematous - Grade 4
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash generalised - Grade 2
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Surgical and medical procedures
Coronary artery bypass - Grade 4
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
Other adverse events
| Measure |
Phase I - Dose Escalation
n=13 participants at risk
Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
Phase II
n=25 participants at risk
Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia - Grade 1
|
0.00%
0/13
|
20.0%
5/25 • Number of events 5
|
|
Blood and lymphatic system disorders
Anaemia - Grade 2
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Blood and lymphatic system disorders
Anaemia - Grade 3
|
7.7%
1/13 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Granulocytopenia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia - Grade 3
|
0.00%
0/13
|
12.0%
3/25 • Number of events 3
|
|
Blood and lymphatic system disorders
Lymphadenopathy - Grade 2
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 2
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Blood and lymphatic system disorders
Lymphopenia - Grade 3
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 2
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 3
|
15.4%
2/13 • Number of events 4
|
20.0%
5/25 • Number of events 7
|
|
Blood and lymphatic system disorders
Neutropenia - Grade 4
|
15.4%
2/13 • Number of events 3
|
12.0%
3/25 • Number of events 3
|
|
Blood and lymphatic system disorders
Pancytopenia - Grade 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 2
|
0.00%
0/13
|
12.0%
3/25 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 3
|
0.00%
0/13
|
20.0%
5/25 • Number of events 5
|
|
Cardiac disorders
Bradycardia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Eye disorders
Diplopia - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Eye disorders
Eye swelling - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Eye disorders
Vision blurred - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Eye disorders
Vision blurred - Grade 2
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Eye disorders
Visual disturbance - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal tenderness - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Constipation - Grade 1
|
15.4%
2/13 • Number of events 2
|
20.0%
5/25 • Number of events 5
|
|
Gastrointestinal disorders
Constipation - Grade 2
|
0.00%
0/13
|
16.0%
4/25 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea - Grade 3
|
7.7%
1/13 • Number of events 2
|
0.00%
0/25
|
|
Gastrointestinal disorders
Dry mouth - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 2
|
|
Gastrointestinal disorders
Hypoaesthesia oral - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 3
|
|
Gastrointestinal disorders
Nausea - Grade 1
|
15.4%
2/13 • Number of events 2
|
16.0%
4/25 • Number of events 4
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Paraesthesia oral - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Asthenia - Grade 1
|
7.7%
1/13 • Number of events 1
|
16.0%
4/25 • Number of events 4
|
|
General disorders
Asthenia - Grade 2
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Asthenia - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Chest pain - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Chest pain - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Chills - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Face oedema - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Fatigue - Grade 1
|
15.4%
2/13 • Number of events 2
|
44.0%
11/25 • Number of events 13
|
|
General disorders
Fatigue - Grade 2
|
7.7%
1/13 • Number of events 1
|
12.0%
3/25 • Number of events 3
|
|
General disorders
Fatigue - Grade 3
|
0.00%
0/13
|
12.0%
3/25 • Number of events 3
|
|
General disorders
Gait disturbance - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Generalised oedema - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Influenza like illness - Grade 2
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Non-cardiac chest pain - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Oedema - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Oedema - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Oedema peripheral - Grade 1
|
15.4%
2/13 • Number of events 2
|
28.0%
7/25 • Number of events 8
|
|
General disorders
Oedema peripheral - Grade 2
|
7.7%
1/13 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Pain - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Pain - Grade 2
|
0.00%
0/13
|
8.0%
2/25 • Number of events 3
|
|
General disorders
Pain - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Pyrexia - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Temperature intolerance - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Tenderness - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 2
|
|
Hepatobiliary disorders
Hyperbilirubinaemia - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Immune system disorders
Hypersensitivity - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Candidiasis - Grade 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Ear infection - Grade 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Fungal infection - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Herpes simplex - Grade 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Influenza - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Oral candidiasis - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Pneumonia - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Sinusitis - Grade 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Infections and infestations
Upper respiratory tract infection - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection - Grade 2
|
15.4%
2/13 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
|
Injury, poisoning and procedural complications
Sunburn - Grade 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Injury, poisoning and procedural complications
Thermal burn - Grade 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Investigations
Activated partial thromboplastin time prolonged - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Investigations
Blood albumin decreased - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Investigations
Blood bicarbonate decreased - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Blood chloride increased - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Investigations
Blood creatine increased - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Blood creatinine increased - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Investigations
Blood creatinine increased - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Blood creatinine increased - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Blood phosphorus - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Blood potassium increased - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Blood urea increased - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Blood uric acid increased - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Haemoglobin decreased - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Haemoglobin decreased - Grade 3
|
7.7%
1/13 • Number of events 2
|
0.00%
0/25
|
|
Investigations
Hepatic enzyme increased - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Hepatic enzyme increased - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Liver function test abnormal - Grade 2
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Investigations
Neutrophil count decreased - Grade 2
|
0.00%
0/13
|
8.0%
2/25 • Number of events 3
|
|
Investigations
Neutrophil count decreased - Grade 4
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Investigations
Platelet count decreased - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Platelet count decreased - Grade 3
|
0.00%
0/13
|
12.0%
3/25 • Number of events 3
|
|
Investigations
Protein total decreased - Grade 1
|
0.00%
0/13
|
12.0%
3/25 • Number of events 3
|
|
Investigations
Protein total decreased - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Prothrombin level abnormal - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Weight decreased - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Weight decreased - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
Weight increased - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Investigations
White blood cell count decreased - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite - Grade 1
|
0.00%
0/13
|
16.0%
4/25 • Number of events 5
|
|
Metabolism and nutrition disorders
Decreased appetite - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid retention - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 1
|
0.00%
0/13
|
20.0%
5/25 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperglycaemia - Grade 3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Metabolism and nutrition disorders
Hyperkalaemia - Grade 1
|
0.00%
0/13
|
12.0%
3/25 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperkalaemia - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypermagnesaemia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperphosphataemia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperphosphataemia - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricaemia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia - Grade 1
|
0.00%
0/13
|
16.0%
4/25 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia - Grade 1
|
0.00%
0/13
|
16.0%
4/25 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypocalcaemia - Grade 2
|
0.00%
0/13
|
12.0%
3/25 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcaemia - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoproteinaemia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - Grade 1
|
0.00%
0/13
|
12.0%
3/25 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 1
|
0.00%
0/13
|
12.0%
3/25 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain - Grade 1
|
7.7%
1/13 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity - Grade 1
|
7.7%
1/13 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare - Grade 1
|
0.00%
0/13
|
20.0%
5/25 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Amnesia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Convulsion - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Disturbance in attention - Grade 1
|
7.7%
1/13 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Dizziness - Grade 1
|
15.4%
2/13 • Number of events 3
|
28.0%
7/25 • Number of events 8
|
|
Nervous system disorders
Dizziness - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Dizziness - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Dizziness postural - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Headache - Grade 1
|
0.00%
0/13
|
12.0%
3/25 • Number of events 3
|
|
Nervous system disorders
Headache - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia - Grade 1
|
7.7%
1/13 • Number of events 1
|
8.0%
2/25 • Number of events 4
|
|
Nervous system disorders
Hypoaesthesia - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 2
|
|
Nervous system disorders
Memory impairment - Grade 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Nervous system disorders
Neuropathy - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral - Grade 1
|
0.00%
0/13
|
20.0%
5/25 • Number of events 6
|
|
Nervous system disorders
Paraesthesia - Grade 1
|
15.4%
2/13 • Number of events 3
|
0.00%
0/25
|
|
Nervous system disorders
Sinus headache - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Somnolence - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Nervous system disorders
Tremor - Grade 1
|
7.7%
1/13 • Number of events 2
|
20.0%
5/25 • Number of events 6
|
|
Psychiatric disorders
Anxiety - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Psychiatric disorders
Confusional state - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Psychiatric disorders
Depression - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Psychiatric disorders
Depression - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Psychiatric disorders
Insomnia - Grade 1
|
7.7%
1/13 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
|
Psychiatric disorders
Insomnia - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Psychiatric disorders
Mood swings - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Renal and urinary disorders
Renal failure - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Asthma - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 1
|
15.4%
2/13 • Number of events 2
|
16.0%
4/25 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea - Grade 2
|
0.00%
0/13
|
12.0%
3/25 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional - Grade 1
|
15.4%
2/13 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion - Grade 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin - Grade 1
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Erythema - Grade 1
|
7.7%
1/13 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail disorder - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Night sweats - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus - Grade 1
|
0.00%
0/13
|
20.0%
5/25 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Pruritus - Grade 2
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised - Grade 2
|
0.00%
0/13
|
8.0%
2/25 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 1
|
23.1%
3/13 • Number of events 3
|
24.0%
6/25 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 2
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash generalised - Grade 1
|
7.7%
1/13 • Number of events 1
|
20.0%
5/25 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash generalised - Grade 2
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Rash generalised - Grade 3
|
7.7%
1/13 • Number of events 1
|
4.0%
1/25 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash pruritic - Grade 1
|
7.7%
1/13 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash pruritic - Grade 3
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation - Grade 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/25
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling face - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
|
Vascular disorders
Hypotension - Grade 1
|
0.00%
0/13
|
4.0%
1/25 • Number of events 1
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place