Trial Outcomes & Findings for S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery (NCT NCT00243074)
NCT ID: NCT00243074
Last Updated: 2018-01-23
Results Overview
confirmed complete and partial responses per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
54 participants
Primary outcome timeframe
Disease assessments for response were performed every 8 weeks for as long as the patient remained on protocol treatment, up to 5 years.
Results posted on
2018-01-23
Participant Flow
Participant milestones
| Measure |
AZD2171 (Cediranib Maleate)
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
AZD2171 (Cediranib Maleate)
|
|---|---|
|
Overall Study
Ineligible
|
6
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lack of Efficacy
|
36
|
|
Overall Study
Death
|
2
|
|
Overall Study
not protocol specified
|
1
|
|
Overall Study
Did not receive any treatment
|
1
|
Baseline Characteristics
S0509 - AZD2171 in Treating Patients With Malignant Pleural Mesothelioma That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
AZD2171
n=47 Participants
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Disease assessments for response were performed every 8 weeks for as long as the patient remained on protocol treatment, up to 5 years.Population: Eligible patients who received any amount of AZD2171
confirmed complete and partial responses per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".
Outcome measures
| Measure |
AZD2171 (Cediranib Maleate)
n=47 Participants
|
|---|---|
|
Overall Response Rate
|
9 percentage of participants
Interval 2.0 to 20.0
|
SECONDARY outcome
Timeframe: Daily during protocol treatment; then every 8 weeks until progression; then every 6 months for up to 3 years.Population: Eligible patients who received AZD2171
From the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
Outcome measures
| Measure |
AZD2171 (Cediranib Maleate)
n=47 Participants
|
|---|---|
|
Overall Survival
|
9.5 months
Interval 5.6 to 10.7
|
SECONDARY outcome
Timeframe: Every 8 weeks until disease progression or death, up to 5 years.Population: Eligible patients who received AZD2171
From the date of enrollment until the date of disease progression (as determined by standard RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
AZD2171 (Cediranib Maleate)
n=47 Participants
|
|---|---|
|
Progression-free Survival
|
2.6 months
Interval 1.7 to 3.7
|
SECONDARY outcome
Timeframe: Every 8 weeks until disease progression progression, up to 5 years.Population: Eligible patients who received AZD2171
The percentage of patients with a best of response of stable disease or better per standard RECIST. That is, patients whose best response was not increasing disease or death.
Outcome measures
| Measure |
AZD2171 (Cediranib Maleate)
n=47 Participants
|
|---|---|
|
Disease Control Rate
|
44 percentage of participants
Interval 28.0 to 58.0
|
SECONDARY outcome
Timeframe: Disease assessments for response were performed every 8 weeks as long as the patient remained on protocol treatment, up to 5 years.Population: Eligible patients who received any amount of AZD2171
The sum of 6 pleural thickness measurements is added to sum of the longest diameters of all non-pleural measurable lesions. The resulting values are evaluated using RECIST.
Outcome measures
| Measure |
AZD2171 (Cediranib Maleate)
n=47 Participants
|
|---|---|
|
Objective Response Rate Per Modified RECIST for Pleural Tumors
|
2 percentage of participants
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: Daily during protocol treatmentPopulation: All patients who received protocol treatment were assessed for adverse events. See adverse event tables for specific details.
Adverse events per the NCI Common Toxicity Criteria version 3.0 that were possibly, probably or definitely related to protocol treatment. See adverse event tables for specific details.
Outcome measures
| Measure |
AZD2171 (Cediranib Maleate)
n=47 Participants
|
|---|---|
|
Adverse Event Rates
|
47 Participants
|
SECONDARY outcome
Timeframe: Patients were assessed for adverse events every day for as long as they remained on protocol treatment, up to 5 years.Population: Eligible patients who received any amount of protocol treatment with AZD2171 (cediranib maleate)
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
AZD2171 (Cediranib Maleate)
n=47 Participants
|
|---|---|
|
Adverse Events
Sodium, serum-low (hyponatremia)
|
1 Participants
|
|
Adverse Events
Speech impairment (e.g., dysphasia or aphasia)
|
1 Participants
|
|
Adverse Events
Anorexia
|
3 Participants
|
|
Adverse Events
Apnea
|
1 Participants
|
|
Adverse Events
Ataxia (incoordination)
|
1 Participants
|
|
Adverse Events
Cognitive disturbance
|
1 Participants
|
|
Adverse Events
Colitis
|
1 Participants
|
|
Adverse Events
Confusion
|
2 Participants
|
|
Adverse Events
Constipation
|
1 Participants
|
|
Adverse Events
Dehydration
|
3 Participants
|
|
Adverse Events
Diarrhea
|
4 Participants
|
|
Adverse Events
Dizziness
|
1 Participants
|
|
Adverse Events
Encephalopathy
|
1 Participants
|
|
Adverse Events
Fatigue (asthenia, lethargy, malaise)
|
7 Participants
|
|
Adverse Events
Hypertension
|
15 Participants
|
|
Adverse Events
Hypotension
|
1 Participants
|
|
Adverse Events
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
1 Participants
|
|
Adverse Events
Memory impairment
|
1 Participants
|
|
Adverse Events
Metabolic/Laboratory-Other (Specify)
|
1 Participants
|
|
Adverse Events
Muscle weakness, not d/t neuropathy - body/general
|
1 Participants
|
|
Adverse Events
Nausea
|
2 Participants
|
|
Adverse Events
Necrosis, GI - Esophagus
|
1 Participants
|
|
Adverse Events
Neuropathy: sensory
|
1 Participants
|
|
Adverse Events
Pain - Chest wall
|
1 Participants
|
|
Adverse Events
Pain - Head/headache
|
1 Participants
|
|
Adverse Events
Pain - Intestine
|
1 Participants
|
|
Adverse Events
Pain - Pain NOS
|
1 Participants
|
|
Adverse Events
Pain - Tumor pain
|
1 Participants
|
|
Adverse Events
Perforation, GI - Ileum
|
1 Participants
|
|
Adverse Events
Potassium, serum-low (hypokalemia)
|
1 Participants
|
|
Adverse Events
Proteinuria
|
2 Participants
|
|
Adverse Events
Rash: hand-foot skin reaction
|
2 Participants
|
|
Adverse Events
Renal failure
|
2 Participants
|
|
Adverse Events
Thrombosis/thrombus/embolism
|
3 Participants
|
|
Adverse Events
Vomiting
|
1 Participants
|
|
Adverse Events
Weight loss
|
2 Participants
|
Adverse Events
AZD2171
Serious events: 22 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD2171
n=47 participants at risk
|
|---|---|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify)
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Necrosis, GI - Esophagus
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Obstruction, GI - Small bowel NOS
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Pain - Peritoneum
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Perforation, GI - Colon
|
2.1%
1/47 • Daily during protocol treatment.
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
2.1%
1/47 • Daily during protocol treatment.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
2.1%
1/47 • Daily during protocol treatment.
|
|
General disorders
Sudden death
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Infections and infestations
Inf (clin/microbio) w/Gr 3-4 neuts - Blood
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Blood
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Infections and infestations
Inf w/normal ANC or Gr 1-2 neutrophils - Lung
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Infections and infestations
Infection-Other (Specify)
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, not d/t neuropathy - body/general
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death - Disease progression NOS
|
17.0%
8/47 • Daily during protocol treatment.
|
|
Nervous system disorders
Ataxia (incoordination)
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Nervous system disorders
Cognitive disturbance
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Nervous system disorders
Encephalopathy
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Nervous system disorders
Memory impairment
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Psychiatric disorders
Confusion
|
4.3%
2/47 • Daily during protocol treatment.
|
|
Renal and urinary disorders
Hemorrhage, GU - Urethra
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Renal and urinary disorders
Renal failure
|
4.3%
2/47 • Daily during protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat/pharynx/larynx
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Vascular disorders
Hypertension
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Vascular disorders
Hypotension
|
2.1%
1/47 • Daily during protocol treatment.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
4.3%
2/47 • Daily during protocol treatment.
|
Other adverse events
| Measure |
AZD2171
n=47 participants at risk
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
27.7%
13/47 • Daily during protocol treatment.
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
10.6%
5/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Constipation
|
21.3%
10/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
63.8%
30/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
10.6%
5/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
10.6%
5/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
10.6%
5/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Gastrointestinal-Other (Specify)
|
14.9%
7/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
10.6%
5/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symp) - Oral cav
|
8.5%
4/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Nausea
|
36.2%
17/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
14.9%
7/47 • Daily during protocol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
21.3%
10/47 • Daily during protocol treatment.
|
|
General disorders
Constitutional Symptoms-Other (Specify)
|
6.4%
3/47 • Daily during protocol treatment.
|
|
General disorders
Edema: limb
|
10.6%
5/47 • Daily during protocol treatment.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
74.5%
35/47 • Daily during protocol treatment.
|
|
General disorders
Pain - Chest/thorax NOS
|
12.8%
6/47 • Daily during protocol treatment.
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Gr 3-4 thrombocytopenia)
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
17.0%
8/47 • Daily during protocol treatment.
|
|
Investigations
AST, SGOT
|
17.0%
8/47 • Daily during protocol treatment.
|
|
Investigations
Alkaline phosphatase
|
14.9%
7/47 • Daily during protocol treatment.
|
|
Investigations
Creatinine
|
19.1%
9/47 • Daily during protocol treatment.
|
|
Investigations
Leukocytes (total WBC)
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Investigations
Lymphopenia
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Investigations
Metabolic/Laboratory-Other (Specify)
|
19.1%
9/47 • Daily during protocol treatment.
|
|
Investigations
Platelets
|
14.9%
7/47 • Daily during protocol treatment.
|
|
Investigations
Weight loss
|
36.2%
17/47 • Daily during protocol treatment.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
19.1%
9/47 • Daily during protocol treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
42.6%
20/47 • Daily during protocol treatment.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
10.6%
5/47 • Daily during protocol treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.9%
7/47 • Daily during protocol treatment.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
38.3%
18/47 • Daily during protocol treatment.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
10.6%
5/47 • Daily during protocol treatment.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
8.5%
4/47 • Daily during protocol treatment.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
14.9%
7/47 • Daily during protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
8.5%
4/47 • Daily during protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
8.5%
4/47 • Daily during protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
12.8%
6/47 • Daily during protocol treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Nervous system disorders
Neuropathy: sensory
|
10.6%
5/47 • Daily during protocol treatment.
|
|
Nervous system disorders
Pain - Head/headache
|
19.1%
9/47 • Daily during protocol treatment.
|
|
Psychiatric disorders
Insomnia
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Psychiatric disorders
Mood alteration - anxiety
|
8.5%
4/47 • Daily during protocol treatment.
|
|
Psychiatric disorders
Mood alteration - depression
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Renal and urinary disorders
Proteinuria
|
29.8%
14/47 • Daily during protocol treatment.
|
|
Renal and urinary disorders
Renal/Genitourinary-Other (Specify)
|
10.6%
5/47 • Daily during protocol treatment.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.8%
14/47 • Daily during protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
38.3%
18/47 • Daily during protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-Other (Specify)
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
36.2%
17/47 • Daily during protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
8.5%
4/47 • Daily during protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
6.4%
3/47 • Daily during protocol treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
8.5%
4/47 • Daily during protocol treatment.
|
|
Vascular disorders
Hypertension
|
72.3%
34/47 • Daily during protocol treatment.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
6.4%
3/47 • Daily during protocol treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60