Trial Outcomes & Findings for AZD2171 in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer (NCT NCT00275028)
NCT ID: NCT00275028
Last Updated: 2015-11-09
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RESIST) Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2015-11-09
Participant Flow
Participant milestones
| Measure |
Treatment (Cediranib Maleate)
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
47
|
Reasons for withdrawal
| Measure |
Treatment (Cediranib Maleate)
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Overall Study
Withdrew consent before treatment began
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Progressive Disease
|
30
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
AZD2171 in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Cediranib Maleate)
n=46 Participants
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Age, Continuous
|
56.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White (non-Hispanic)
|
45 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
|
Platinum Sensitivity
Platinum Sensitive
|
16 participants
n=5 Participants
|
|
Platinum Sensitivity
Platinum Resistant
|
30 participants
n=5 Participants
|
|
Primary Cancer Diagnosis
Ovarian cancer
|
40 participants
n=5 Participants
|
|
Primary Cancer Diagnosis
Fallopian tube cancer
|
1 participants
n=5 Participants
|
|
Primary Cancer Diagnosis
Peritoneal cancer
|
5 participants
n=5 Participants
|
|
Histologic Subtype
Papillary serous
|
38 participants
n=5 Participants
|
|
Histologic Subtype
Endometrioid
|
1 participants
n=5 Participants
|
|
Histologic Subtype
Clear cell
|
3 participants
n=5 Participants
|
|
Histologic Subtype
Mixed type or other
|
4 participants
n=5 Participants
|
|
ECOG PS
0
|
34 participants
n=5 Participants
|
|
ECOG PS
1
|
12 participants
n=5 Participants
|
|
Tumor grade
1
|
1 participants
n=5 Participants
|
|
Tumor grade
2
|
0 participants
n=5 Participants
|
|
Tumor grade
2-3
|
6 participants
n=5 Participants
|
|
Tumor grade
3
|
39 participants
n=5 Participants
|
|
Response Assessment
RECIST
|
36 participants
n=5 Participants
|
|
Response Assessment
CA-125
|
10 participants
n=5 Participants
|
|
Number of Prior Therapies for Recurrent Cancer
0
|
19 participants
n=5 Participants
|
|
Number of Prior Therapies for Recurrent Cancer
1
|
22 participants
n=5 Participants
|
|
Number of Prior Therapies for Recurrent Cancer
2
|
5 participants
n=5 Participants
|
|
Prior History of Hypertension
Yes
|
6 participants
n=5 Participants
|
|
Prior History of Hypertension
No
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RESIST) Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Outcome measures
| Measure |
Treatment (Cediranib Maleate)
n=35 Participants
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Clinical Response Benefit (Modified Gynecologic Cancer InterGroup [GCIG] Cancer Antigen [CA]-125 Response or Stable Disease) Based on the Response Evaluation Criteria in Solid Tumors (RECIST)
Stable Disease
|
6 participants
|
|
Clinical Response Benefit (Modified Gynecologic Cancer InterGroup [GCIG] Cancer Antigen [CA]-125 Response or Stable Disease) Based on the Response Evaluation Criteria in Solid Tumors (RECIST)
Complete Response
|
0 participants
|
|
Clinical Response Benefit (Modified Gynecologic Cancer InterGroup [GCIG] Cancer Antigen [CA]-125 Response or Stable Disease) Based on the Response Evaluation Criteria in Solid Tumors (RECIST)
Partial Response
|
8 participants
|
|
Clinical Response Benefit (Modified Gynecologic Cancer InterGroup [GCIG] Cancer Antigen [CA]-125 Response or Stable Disease) Based on the Response Evaluation Criteria in Solid Tumors (RECIST)
Progressive Disease
|
21 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsOutcome measures
| Measure |
Treatment (Cediranib Maleate)
n=46 Participants
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Progression-free Survival
|
18.43 weeks
Standard Error 1.4278
|
Adverse Events
Treatment (Cediranib Maleate)
Serious events: 17 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Cediranib Maleate)
n=46 participants at risk
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Nervous system disorders
CNS hemorrhage
|
2.2%
1/46
|
|
Gastrointestinal disorders
Rectal pain
|
4.3%
2/46
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.5%
3/46
|
|
Gastrointestinal disorders
Small bowel obstruction
|
8.7%
4/46
|
|
General disorders
Fatigue
|
2.2%
1/46
|
|
Gastrointestinal disorders
Mucositis
|
2.2%
1/46
|
|
Endocrine disorders
Hypothyroidism
|
2.2%
1/46
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.2%
1/46
|
|
Gastrointestinal disorders
Colitis
|
2.2%
1/46
|
|
Renal and urinary disorders
Urinary tract infection
|
2.2%
1/46
|
|
General disorders
Hypothermia
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
1/46
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/46
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/46
|
|
Cardiac disorders
Hypertension
|
2.2%
1/46
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/46
|
Other adverse events
| Measure |
Treatment (Cediranib Maleate)
n=46 participants at risk
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
cediranib maleate: Given orally
laboratory biomarker analysis: Correlative studies
pharmacological study: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
91.3%
42/46
|
|
General disorders
Fatigue
|
91.3%
42/46
|
|
Cardiac disorders
Hypertension
|
78.3%
36/46
|
|
Endocrine disorders
Hypothyroidism
|
56.5%
26/46
|
|
Gastrointestinal disorders
Mucositis
|
52.2%
24/46
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
45.7%
21/46
|
|
Gastrointestinal disorders
Nausea
|
43.5%
20/46
|
|
Nervous system disorders
Headache
|
47.8%
22/46
|
|
Gastrointestinal disorders
Abdominal pain
|
45.7%
21/46
|
|
Renal and urinary disorders
Proteinuria
|
21.7%
10/46
|
|
Gastrointestinal disorders
Vomiting
|
34.8%
16/46
|
|
Gastrointestinal disorders
Anorexia
|
19.6%
9/46
|
|
Gastrointestinal disorders
Weight loss
|
17.4%
8/46
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
13.0%
6/46
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
13.0%
6/46
|
|
Gastrointestinal disorders
Constipation
|
17.4%
8/46
|
|
Metabolism and nutrition disorders
Dehydration
|
13.0%
6/46
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.9%
5/46
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
10.9%
5/46
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.1%
12/46
|
|
Investigations
ALT
|
15.2%
7/46
|
|
Metabolism and nutrition disorders
Alkaline phosphatase elevated
|
8.7%
4/46
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.9%
5/46
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.7%
4/46
|
|
Psychiatric disorders
Insomnia
|
6.5%
3/46
|
|
Metabolism and nutrition disorders
AST
|
13.0%
6/46
|
|
Vascular disorders
Hot flashes
|
6.5%
3/46
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.7%
4/46
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
6/46
|
|
Renal and urinary disorders
Urinary tract infection
|
10.9%
5/46
|
|
General disorders
Fever
|
6.5%
3/46
|
|
Gastrointestinal disorders
Bloating
|
6.5%
3/46
|
|
Gastrointestinal disorders
Dry mouth
|
10.9%
5/46
|
|
Gastrointestinal disorders
Dyspepsia
|
10.9%
5/46
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.6%
9/46
|
|
General disorders
Chest pain
|
8.7%
4/46
|
|
Investigations
Hemoglobin increased
|
6.5%
3/46
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.5%
3/46
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.9%
5/46
|
|
Investigations
Creatinine increased
|
6.5%
3/46
|
|
Nervous system disorders
Neuropathy
|
32.6%
15/46
|
|
Investigations
Thrombocytopenia
|
6.5%
3/46
|
|
Gastrointestinal disorders
Oral pain
|
6.5%
3/46
|
|
Endocrine disorders
Hyperthyroidism
|
8.7%
4/46
|
|
Investigations
Neutropenia
|
8.7%
4/46
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60