Trial Outcomes & Findings for Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery (NCT NCT00309946)
NCT ID: NCT00309946
Last Updated: 2014-07-31
Results Overview
Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Every 8 weeks
Results posted on
2014-07-31
Participant Flow
Participant milestones
| Measure |
Treatment (Enzyme Inhibitor Therapy)
Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
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|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Enzyme Inhibitor Therapy)
Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=51 Participants
Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 8 weeksEvaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met.
Outcome measures
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=50 Participants
Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
|
|---|---|
|
Objective Response Rate, Complete (CR) or Partial (PR) Response
|
5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, days 15 and 29 of course 1, and then every 28 daysPopulation: This outcome was not measured/assessed for any of the study subjects.
Examined using paired t-test or Wilcoxon signed-ranks test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1 of course 1Population: This outcome was not measured/assessed for any of the study subjects.
Focus on variants of genes in the pathway targeted by cediranib maleate, including kdr/flk-1 (the specific target of cediranib maleate) and the genes that encode Vascular endothelial growth factor A (VEGF-A) or HIF1α. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Enzyme Inhibitor Therapy)
Serious events: 31 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=51 participants at risk
Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Abdominal pain
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Immune system disorders
Anaphylaxis
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Anorexia
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Cardiac disorders
Atrial flutter
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Cardiac disorders
Cardiac arrest
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Chest wall pain
|
5.9%
3/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Nervous system disorders
Cognitive disturbance
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Cardiac disorders
Conduction disorder
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Nervous system disorders
Confusion
|
3.9%
2/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Constipation
|
3.9%
2/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Creatinine increased
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Dehydration
|
3.9%
2/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Nervous system disorders
Depressed level of consciousness
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
3.9%
2/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Nervous system disorders
Dizziness
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.7%
7/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Cardiac disorders
ECG QTc interval prolonged
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Nervous system disorders
Encephalopathy
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Failure to thrive
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Fatigue
|
3.9%
2/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Headache
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Cardiac disorders
Hypertension
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Cardiac disorders
Hypotension
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Infections and infestations
Infection with unknown ANC: Blood
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Intracranial hemorrhage
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Cardiac disorders
Mobitz (type) II atrioventricular block
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.9%
2/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
3.9%
2/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Nervous system disorders
Seizure
|
3.9%
2/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Infections and infestations
Sepsis
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Cardiac disorders
Sinus tachycardia
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Vascular disorders
Thromboembolic event
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Renal and urinary disorders
Urinary retention
|
2.0%
1/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
Other adverse events
| Measure |
Treatment (Enzyme Inhibitor Therapy)
n=51 participants at risk
Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
|
|---|---|
|
General disorders
Abdominal pain
|
15.7%
8/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Alanine aminotransferase (ALT) increased
|
21.6%
11/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase (ALP) increased
|
17.6%
9/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Immune system disorders
Allergic rhinitis
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Blood and lymphatic system disorders
Anemia
|
45.1%
23/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Anorexia
|
54.9%
28/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Nervous system disorders
Anxiety
|
9.8%
5/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Arthralgia
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase (AST) increased
|
19.6%
10/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Back pain
|
19.6%
10/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Chest wall pain
|
45.1%
23/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Constipation
|
25.5%
13/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.5%
12/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Creatinine increased
|
11.8%
6/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Dehydration
|
5.9%
3/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Nervous system disorders
Depression
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
58.8%
30/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Dysgeusia
|
9.8%
5/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
17.6%
9/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
11.8%
6/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
29.4%
15/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Blood and lymphatic system disorders
Edema (limb)
|
9.8%
5/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Blood and lymphatic system disorders
Epistaxis
|
11.8%
6/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Fatigue
|
68.6%
35/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Headache
|
17.6%
9/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Renal and urinary disorders
Hematuria
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
51.0%
26/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
13.7%
7/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Cardiac disorders
Hypertension
|
56.9%
29/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
39.2%
20/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
13.7%
7/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
35.3%
18/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Blood and lymphatic system disorders
Hypotension
|
5.9%
3/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Endocrine disorders
Hypothyroidism
|
21.6%
11/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Insomnia
|
9.8%
5/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
27.5%
14/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Mucositis (oral)
|
23.5%
12/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
17/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Oral pain
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Pain - Other
|
11.8%
6/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Pain in extremity
|
11.8%
6/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
9.8%
5/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Pharyngolaryngeal pain
|
9.8%
5/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
15.7%
8/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
27.5%
14/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash (maculo-papular)
|
11.8%
6/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Cardiac disorders
Sinus tachycardia
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
21.6%
11/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
9/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
General disorders
Weight loss
|
23.5%
12/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
7.8%
4/51 • After completion of study treatment, patients are followed for up to 8 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60