Trial Outcomes & Findings for ZD4054 (Zibotentan) Phase II Non-Small Cell Lung Cancer Study (NCT NCT00745875)
NCT ID: NCT00745875
Last Updated: 2012-06-06
Results Overview
Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Patients were followed up for survival every week for the first 3 weeks then every 3 weeks whilst on study medication until the data cut-off (17th January 2010).
Results posted on
2012-06-06
Participant Flow
80 patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) where the histology was not predominantly of squamous type were recruited between 12th August 2008 and 3rd June 2009.
14 of the 80 enrolled patients were not randomised to treatments groups: 7 patients did not meet one or more of the study inclusion or exclusion criteria, 3 patients failed screening, 2 patients were not included due to investigator decision, 1 patient withdrew consent and 1 patient died.
Participant milestones
| Measure |
Placebo + Pemetrexed
Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
|
ZD4054 + Pemetrexed
ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
30
|
|
Overall Study
COMPLETED
|
32
|
26
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Placebo + Pemetrexed
Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
|
ZD4054 + Pemetrexed
ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
|
|---|---|---|
|
Overall Study
Continuing study treatment
|
4
|
4
|
Baseline Characteristics
ZD4054 (Zibotentan) Phase II Non-Small Cell Lung Cancer Study
Baseline characteristics by cohort
| Measure |
Placebo + Pemetrexed
n=36 Participants
Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
|
ZD4054 + Pemetrexed
n=30 Participants
ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56.6 Years
STANDARD_DEVIATION 12.06 • n=5 Participants
|
57.5 Years
STANDARD_DEVIATION 10.44 • n=7 Participants
|
57 Years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients were followed up for survival every week for the first 3 weeks then every 3 weeks whilst on study medication until the data cut-off (17th January 2010).Median time (in days) from randomisation until death using the Kaplan-Meier method (Calculator for survival probability)
Outcome measures
| Measure |
Placebo + Pemetrexed
n=36 Participants
Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
|
ZD4054 + Pemetrexed
n=30 Participants
ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
|
|---|---|---|
|
Time to Death
|
193 Days
Interval 27.0 to 437.0
|
146 Days
Interval 19.0 to 427.0
|
SECONDARY outcome
Timeframe: Tumour assessments for progression were performed at screening, every 3 weeks, Mandatory Tumour Assessment Visit (19 August 2009 ± 3 days), treatment discontinuationMedian time (in days) from randomisation until disease progression/death using the Kaplan-Meier method
Outcome measures
| Measure |
Placebo + Pemetrexed
n=36 Participants
Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
|
ZD4054 + Pemetrexed
n=30 Participants
ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
|
|---|---|---|
|
Progression-free Survival
|
87 Days
Interval 27.0 to 283.0
|
110 Days
Interval 18.0 to 303.0
|
Adverse Events
Placebo + Pemetrexed
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
ZD4054 + Pemetrexed
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Pemetrexed
n=30 participants at risk
Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
|
ZD4054 + Pemetrexed
n=36 participants at risk
ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
1/30
|
0.00%
0/36
|
|
Blood and lymphatic system disorders
Febrile Bone Marrow Aplasia
|
3.3%
1/30
|
0.00%
0/36
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/30
|
2.8%
1/36
|
|
Cardiac disorders
Right Ventricular Failure
|
3.3%
1/30
|
0.00%
0/36
|
|
Gastrointestinal disorders
Pancreatitis
|
3.3%
1/30
|
0.00%
0/36
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
3.3%
1/30
|
0.00%
0/36
|
|
General disorders
Adverse Drug Reaction
|
3.3%
1/30
|
0.00%
0/36
|
|
General disorders
Asthenia
|
3.3%
1/30
|
0.00%
0/36
|
|
Infections and infestations
Erysipelas
|
0.00%
0/30
|
2.8%
1/36
|
|
Infections and infestations
Lung Infection
|
0.00%
0/30
|
2.8%
1/36
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
3.3%
1/30
|
0.00%
0/36
|
|
Renal and urinary disorders
Renal Failure
|
3.3%
1/30
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/30
|
2.8%
1/36
|
Other adverse events
| Measure |
Placebo + Pemetrexed
n=30 participants at risk
Pemetrexed 500 mg/m2 Intravenous (IV) infusion every 21 days + placebo oral tablet once daily
|
ZD4054 + Pemetrexed
n=36 participants at risk
ZD4054 10 mg oral tablet once daily + Pemetrexed 500 mg/m2 IV infusion every 21 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.7%
8/30
|
19.4%
7/36
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
5/30
|
2.8%
1/36
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.7%
2/30
|
0.00%
0/36
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30
|
13.9%
5/36
|
|
Gastrointestinal disorders
Constipation
|
6.7%
2/30
|
2.8%
1/36
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30
|
5.6%
2/36
|
|
General disorders
Oedema Peripheral
|
3.3%
1/30
|
11.1%
4/36
|
|
General disorders
Fatigue
|
3.3%
1/30
|
5.6%
2/36
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
6.7%
2/30
|
0.00%
0/36
|
|
Infections and infestations
Bacterial Infection
|
6.7%
2/30
|
0.00%
0/36
|
|
Infections and infestations
Body Temperature Increased
|
10.0%
3/30
|
5.6%
2/36
|
|
Infections and infestations
Brain Natriuretic Peptide Increased
|
0.00%
0/30
|
8.3%
3/36
|
|
Infections and infestations
Weight Decreased
|
10.0%
3/30
|
8.3%
3/36
|
|
Infections and infestations
Alanine Aminotransferase Increased
|
6.7%
2/30
|
5.6%
2/36
|
|
Infections and infestations
Aspartate Aminotransferase Increased
|
3.3%
1/30
|
5.6%
2/36
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
3.3%
1/30
|
5.6%
2/36
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
2/30
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
10.0%
3/30
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.7%
2/30
|
2.8%
1/36
|
|
Nervous system disorders
Headache
|
3.3%
1/30
|
8.3%
3/36
|
|
Psychiatric disorders
Anxiety
|
6.7%
2/30
|
0.00%
0/36
|
|
Psychiatric disorders
Insomnia
|
6.7%
2/30
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30
|
5.6%
2/36
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30
|
8.3%
3/36
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
2/30
|
5.6%
2/36
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AstraZeneca can review results communications prior to public release and may within 60 days of receipt require amendments to be made. AstraZeneca can also require that submission or disclosure be delayed for 90 days to allow for the filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER