Trial Outcomes & Findings for AZD2171 in Treating Patients With Refractory Metastatic Kidney Cancer (NCT NCT00303862)
NCT ID: NCT00303862
Last Updated: 2014-05-21
Results Overview
Objective radiologic response as measured by RECIST criteria. (30% or greater shrinkage in the sum of the longest diameters of target lesions)
TERMINATED
PHASE2
10 participants
Up to 6 weeks
2014-05-21
Participant Flow
Patients were enrolled between December, 2006 and July, 2007 at three institutions. The trial was terminated after 10 patients were enrolled due to insufficent accrual rate.
Participant milestones
| Measure |
Treatment (Cediranib Maleate)
Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AZD2171 in Treating Patients With Refractory Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Cediranib Maleate)
n=10 Participants
Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksObjective radiologic response as measured by RECIST criteria. (30% or greater shrinkage in the sum of the longest diameters of target lesions)
Outcome measures
| Measure |
Treatment (Cediranib Maleate)
n=10 Participants
Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Objective Response
|
20 percentage of participants
Interval 2.5 to 55.6
|
SECONDARY outcome
Timeframe: One month after initiating therapyPopulation: Because trial was closed due to poor accrual, MRI data were not collected.
Binary (yes/no) indicator of whether a dynamic contrast-enhanced MRI (DCE-MRI)was successfully performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 28 after initiation of therapyPopulation: Because trial was closed due to poor accrual, assays were not performed.
Kinase insert domain-containing vascular endothelial growth factor receptor
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (prior to therapy)Population: Because trial was closed due to poor accrual, assays were not performed.
Endothelial nitric oxide synthase gene (eNOS). Record genotype=number of minor alleles.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Cediranib Maleate)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Cediranib Maleate)
n=10 participants at risk
Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
2/10
Grade 2 or higher
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
10.0%
1/10
Grade 2 or higher
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
10.0%
1/10
Grade 2 or higher
|
|
Gastrointestinal disorders
Anorexia
|
10.0%
1/10
Grade 2 or higher
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10
Grade 2 or higher
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10
Grade 2 or higher
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10
Grade 2 or higher
|
|
Metabolism and nutrition disorders
Creatinine increased
|
10.0%
1/10
Grade 2 or higher
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
4/10
Grade 2 or higher
|
|
Ear and labyrinth disorders
Ear, nose, and throat exam abnormal
|
20.0%
2/10
Grade 2 or higher
|
|
General disorders
Fatigue
|
40.0%
4/10
Grade 2 or higher
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10
Grade 2 or higher
|
|
Reproductive system and breast disorders
GU bleeding
|
10.0%
1/10
Grade 2 or higher
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10
Grade 2 or higher
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10
Grade 2 or higher
|
|
General disorders
Hand-and-foot syndrome
|
50.0%
5/10
Grade 2 or higher
|
|
Endocrine disorders
Hyperglycemia
|
10.0%
1/10
Grade 2 or higher
|
|
Cardiac disorders
Hypertension
|
70.0%
7/10
Grade 2 or higher
|
|
Endocrine disorders
Hyperthyroidism
|
10.0%
1/10
Grade 2 or higher
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.0%
1/10
Grade 2 or higher
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
1/10
Grade 2 or higher
|
|
Metabolism and nutrition disorders
Hypophophatemia
|
10.0%
1/10
Grade 2 or higher
|
|
Endocrine disorders
Hypothyroidism
|
30.0%
3/10
Grade 2 or higher
|
|
Infections and infestations
Infection
|
10.0%
1/10
Grade 2 or higher
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
10.0%
1/10
Grade 2 or higher
|
|
Gastrointestinal disorders
Nausea/vomiting
|
10.0%
1/10
Grade 2 or higher
|
|
Nervous system disorders
Neurological disorder NOS
|
10.0%
1/10
Grade 2 or higher
|
|
General disorders
Prostatic pain
|
10.0%
1/10
Grade 2 or higher
|
|
Metabolism and nutrition disorders
Proteinuria
|
30.0%
3/10
Grade 2 or higher
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
10.0%
1/10
Grade 2 or higher
|
|
Nervous system disorders
Seizure
|
10.0%
1/10
Grade 2 or higher
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
1/10
Grade 2 or higher
|
|
Reproductive system and breast disorders
Urogenital disorder
|
10.0%
1/10
Grade 2 or higher
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60