Trial Outcomes & Findings for A Study to Evaluate the Effectiveness of 5-Azacitidine and Bevacizumab in Advanced Renal Cell Carcinoma (NCT NCT00934440)
NCT ID: NCT00934440
Last Updated: 2017-06-14
Results Overview
Toxicities determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
3 to 6 months
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)
All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)
All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
A Study to Evaluate the Effectiveness of 5-Azacitidine and Bevacizumab in Advanced Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)
n=11 Participants
All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 to 6 monthsToxicities determined using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Outcome measures
| Measure |
5-Azacitidine Maximum Tolerated Dose (MTD)
n=11 Participants
|
|---|---|
|
Toxicities by Dose Level
AEs at dose level 1
|
44 adverse events
|
|
Toxicities by Dose Level
AEs at dose level 2
|
48 adverse events
|
|
Toxicities by Dose Level
AEs at dose level 3
|
49 adverse events
|
SECONDARY outcome
Timeframe: 2 yearsThe time to progression was measured using time from the first day of treatment to the first day of an evaluation of progressive disease or the date of death for any cause.
Outcome measures
| Measure |
5-Azacitidine Maximum Tolerated Dose (MTD)
n=11 Participants
|
|---|---|
|
Time to Progression
|
5.6 months
Interval 1.0 to 22.8
|
Adverse Events
Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)
n=11 participants at risk
All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
|
|---|---|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.1%
1/11 • Number of events 1 • 2 years, 1 month
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • Number of events 1 • 2 years, 1 month
|
Other adverse events
| Measure |
Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)
n=11 participants at risk
All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
27.3%
3/11 • 2 years, 1 month
|
|
Endocrine disorders
Adrenal insufficiency
|
9.1%
1/11 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
9.1%
1/11 • 2 years, 1 month
|
|
Gastrointestinal disorders
Anorexia
|
36.4%
4/11 • 2 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
36.4%
4/11 • 2 years, 1 month
|
|
Blood and lymphatic system disorders
Blood - Other (Specify)
|
9.1%
1/11 • 2 years, 1 month
|
|
Gastrointestinal disorders
Colitis
|
9.1%
1/11 • 2 years, 1 month
|
|
Gastrointestinal disorders
Constipation
|
36.4%
4/11 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
45.5%
5/11 • 2 years, 1 month
|
|
Metabolism and nutrition disorders
Creatinine increased
|
27.3%
3/11 • 2 years, 1 month
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • 2 years, 1 month
|
|
Nervous system disorders
Dizziness
|
18.2%
2/11 • 2 years, 1 month
|
|
Ear and labyrinth disorders
Dyspnea
|
36.4%
4/11 • 2 years, 1 month
|
|
Blood and lymphatic system disorders
Edema limbs
|
9.1%
1/11 • 2 years, 1 month
|
|
General disorders
Fatigue
|
72.7%
8/11 • 2 years, 1 month
|
|
Blood and lymphatic system disorders
Hemoglobin
|
9.1%
1/11 • 2 years, 1 month
|
|
Blood and lymphatic system disorders
Hemolysis
|
9.1%
1/11 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
9.1%
1/11 • 2 years, 1 month
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.1%
1/11 • 2 years, 1 month
|
|
Cardiac disorders
Hypertension
|
9.1%
1/11 • 2 years, 1 month
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
9.1%
1/11 • 2 years, 1 month
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
9.1%
1/11 • 2 years, 1 month
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.2%
2/11 • 2 years, 1 month
|
|
Endocrine disorders
Hypothyroidism
|
9.1%
1/11 • 2 years, 1 month
|
|
Infections and infestations
Infection
|
9.1%
1/11 • 2 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
54.5%
6/11 • 2 years, 1 month
|
|
Investigations
INR increased
|
9.1%
1/11 • 2 years, 1 month
|
|
Psychiatric disorders
Insomnia
|
9.1%
1/11 • 2 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
18.2%
2/11 • 2 years, 1 month
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
9.1%
1/11 • 2 years, 1 month
|
|
Metabolism and nutrition disorders
D-dimer 1837
|
9.1%
1/11 • 2 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
18.2%
2/11 • 2 years, 1 month
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • 2 years, 1 month
|
|
Gastrointestinal disorders
Nausea
|
72.7%
8/11 • 2 years, 1 month
|
|
Blood and lymphatic system disorders
Neutrophils
|
18.2%
2/11 • 2 years, 1 month
|
|
Gastrointestinal disorders
Oesophagoscopy abnormal
|
9.1%
1/11 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
9.1%
1/11 • 2 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
tachypnea
|
9.1%
1/11 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
rales (scattered)
|
9.1%
1/11 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
rhonchi (scattered)
|
9.1%
1/11 • 2 years, 1 month
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.1%
1/11 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
9.1%
1/11 • 2 years, 1 month
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • 2 years, 1 month
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • 2 years, 1 month
|
|
Gastrointestinal disorders
Taste alteration
|
9.1%
1/11 • 2 years, 1 month
|
|
Vascular disorders
Thrombosis/embolism (vascular access)
|
9.1%
1/11 • 2 years, 1 month
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
9.1%
1/11 • 2 years, 1 month
|
|
Infections and infestations
Upper respiratory infection
|
9.1%
1/11 • 2 years, 1 month
|
|
Renal and urinary disorders
Urinary frequency
|
9.1%
1/11 • 2 years, 1 month
|
|
Reproductive system and breast disorders
Vaginal discharge
|
9.1%
1/11 • 2 years, 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
9.1%
1/11 • 2 years, 1 month
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
2/11 • 2 years, 1 month
|
|
General disorders
Weight gain
|
9.1%
1/11 • 2 years, 1 month
|
|
General disorders
Weight loss
|
9.1%
1/11 • 2 years, 1 month
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
9.1%
1/11 • 2 years, 1 month
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • 2 years, 1 month
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.1%
1/11 • 2 years, 1 month
|
Additional Information
Dr. Peter Van Velduizen
University of Kansas Cancer Center
Phone: (913) 945-5059
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place