Trial Outcomes & Findings for The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer (NCT NCT00243347)
NCT ID: NCT00243347
Last Updated: 2013-10-17
Results Overview
Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-\[F-18\]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)\*100
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Randomisation until Day 22
Results posted on
2013-10-17
Participant Flow
Participant milestones
| Measure |
Cediranib 30 mg
Cediranib 30mg/Day
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Cediranib 30 mg
Cediranib 30mg/Day
|
|---|---|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Condition worsened
|
7
|
Baseline Characteristics
The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer
Baseline characteristics by cohort
| Measure |
Cediranib 30 mg
n=19 Participants
Cediranib 30mg/Day
|
|---|---|
|
Age Continuous
|
58.1 Years
STANDARD_DEVIATION 12.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Randomisation until Day 22Population: Of the 19 patients, only 17 patients were evaluable for FDG-PET analysis. To be evaluable for FDG-PET, patients had to have FDG-PET data collected at Day 1 and at least one post-baseline visit.
Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-\[F-18\]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value - baseline SUVmax value)/baseline SUVmax value)\*100
Outcome measures
| Measure |
Cediranib 30 mg
n=17 Participants
Cediranib 30mg/Day
|
|---|---|
|
Change From Baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-Fluoro-2-deoxy-D-glucose Positron Emission Tomography (FDG-PET)
|
-18.386 Percentage change in SUVmax
Interval -35.496 to 3.263
|
SECONDARY outcome
Timeframe: Randomisation until Day 22Population: Of the 19 patients, only 17 patients were evaluable MAP analysis. To be evaluable for MAP analysis, patients had to have MAP data collected at Day 1 and at least one post-baseline visit.
Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 - MAP value at baseline).
Outcome measures
| Measure |
Cediranib 30 mg
n=17 Participants
Cediranib 30mg/Day
|
|---|---|
|
Change From Baseline in Mean Arterial Blood Pressure (MAP)
|
6.853 mmHg
95% Confidence Interval 1.010 • Interval 1.01 to 12.696
|
Adverse Events
Cediranib 30 mg
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cediranib 30 mg
n=19 participants at risk
Cediranib 30mg/Day
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19
|
|
Gastrointestinal disorders
Tongue Haemorrhage
|
5.3%
1/19
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Acquired Tracheo-Oesophageal Fistula
|
5.3%
1/19
|
Other adverse events
| Measure |
Cediranib 30 mg
n=19 participants at risk
Cediranib 30mg/Day
|
|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.3%
1/19
|
|
Cardiac disorders
Pericardial Effusion
|
5.3%
1/19
|
|
Endocrine disorders
Hyperthyroidism
|
5.3%
1/19
|
|
Gastrointestinal disorders
Diarrhoea
|
42.1%
8/19
|
|
Gastrointestinal disorders
Enteritis
|
15.8%
3/19
|
|
Gastrointestinal disorders
Nausea
|
15.8%
3/19
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19
|
|
Gastrointestinal disorders
Stomatitis
|
10.5%
2/19
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.3%
1/19
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.3%
1/19
|
|
Gastrointestinal disorders
Dry Mouth
|
5.3%
1/19
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
1/19
|
|
Gastrointestinal disorders
Gingival Bleeding
|
5.3%
1/19
|
|
Gastrointestinal disorders
Oral Pain
|
5.3%
1/19
|
|
General disorders
Fatigue
|
31.6%
6/19
|
|
General disorders
Asthenia
|
21.1%
4/19
|
|
General disorders
Chest Discomfort
|
5.3%
1/19
|
|
General disorders
Chest Pain
|
5.3%
1/19
|
|
General disorders
Localised Oedema
|
5.3%
1/19
|
|
General disorders
Oedema Peripheral
|
5.3%
1/19
|
|
General disorders
Pyrexia
|
5.3%
1/19
|
|
Infections and infestations
Oral Candidiasis
|
5.3%
1/19
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Limb Injury
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Blood Corticotrophin Increased
|
21.1%
4/19
|
|
Injury, poisoning and procedural complications
Weight Decreased
|
21.1%
4/19
|
|
Injury, poisoning and procedural complications
Blood Thyroid Stimulating Hormone Increased
|
10.5%
2/19
|
|
Injury, poisoning and procedural complications
Blood Thyroid Stimulating Hormone Decreased
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Haemoglobin Decreased
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
Urine Colour Abnormal
|
5.3%
1/19
|
|
Injury, poisoning and procedural complications
White Blood Cell Count Decreased
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Anorexia
|
15.8%
3/19
|
|
Metabolism and nutrition disorders
Dehydration
|
15.8%
3/19
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.5%
2/19
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
1/19
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.3%
1/19
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
15.8%
3/19
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
10.5%
2/19
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.3%
1/19
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.3%
1/19
|
|
Nervous system disorders
Aphonia
|
5.3%
1/19
|
|
Nervous system disorders
Cervical Root Pain
|
5.3%
1/19
|
|
Nervous system disorders
Dysarthria
|
5.3%
1/19
|
|
Nervous system disorders
Headache
|
5.3%
1/19
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
1/19
|
|
Nervous system disorders
Migraine
|
5.3%
1/19
|
|
Nervous system disorders
Neuropathy Peripheral
|
5.3%
1/19
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
5.3%
1/19
|
|
Psychiatric disorders
Depression
|
5.3%
1/19
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19
|
|
Renal and urinary disorders
Proteinuria
|
42.1%
8/19
|
|
Renal and urinary disorders
Ketonuria
|
5.3%
1/19
|
|
Renal and urinary disorders
Renal Failure
|
5.3%
1/19
|
|
Reproductive system and breast disorders
Menorrhagia
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
15.8%
3/19
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.5%
2/19
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.8%
3/19
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.5%
2/19
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
5.3%
1/19
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
5.3%
1/19
|
|
Vascular disorders
Hypertension
|
31.6%
6/19
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.
- Publication restrictions are in place
Restriction type: OTHER