Trial Outcomes & Findings for ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer (NCT NCT00929162)
NCT ID: NCT00929162
Last Updated: 2012-08-07
Results Overview
Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Patients were followed for progression up to 2 years
Results posted on
2012-08-07
Participant Flow
132 patients with advanced ovarian cancer sensitive to platinum-based chemotherapy were recruited between 26th June 2009 and 1st June 2011.
12 of the 132 enrolled patients were not randomised to treatment groups as they failed screening
Participant milestones
| Measure |
ZD4054+Paclitaxel+Carboplatin
ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
Placebo+Paclitaxel+Carboplatin
Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
61
|
|
Overall Study
Patients Who Received Treatment
|
58
|
58
|
|
Overall Study
COMPLETED
|
11
|
19
|
|
Overall Study
NOT COMPLETED
|
48
|
42
|
Reasons for withdrawal
| Measure |
ZD4054+Paclitaxel+Carboplatin
ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
Placebo+Paclitaxel+Carboplatin
Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Protocol Violation
|
32
|
30
|
|
Overall Study
Other termination reason
|
5
|
6
|
Baseline Characteristics
ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer
Baseline characteristics by cohort
| Measure |
ZD4054+Paclitaxel+Carboplatin
n=59 Participants
ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
Placebo+Paclitaxel+Carboplatin
n=61 Participants
Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
Overall
|
57.4 Years
STANDARD_DEVIATION 11.98 • n=5 Participants
|
56.6 Years
STANDARD_DEVIATION 11.07 • n=7 Participants
|
57.0 Years
STANDARD_DEVIATION 11.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patients were followed for progression up to 2 yearsMedian time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.
Outcome measures
| Measure |
ZD4054+Paclitaxel+Carboplatin
n=59 Participants
ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
Placebo+Paclitaxel+Carboplatin
n=61 Participants
Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
|---|---|---|
|
Progression Free Survival
|
7.6 Months
Interval 6.6 to 10.2
|
10.0 Months
Interval 7.1 to 12.2
|
SECONDARY outcome
Timeframe: Patients were followed for survival up to 2 yearsPopulation: Overall Survival was not analysed as the study was terminated early.
Median time (in months) from randomisation until death using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years)Population: The number of participants for analysis corresponds to patients with measurable disease at study entry
Objective response rate defined as participants with a complete or partial response according to RECIST
Outcome measures
| Measure |
ZD4054+Paclitaxel+Carboplatin
n=55 Participants
ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
Placebo+Paclitaxel+Carboplatin
n=58 Participants
Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
|---|---|---|
|
Tumour Response Rate
|
21 Participants
|
34 Participants
|
Adverse Events
ZD4054+Paclitaxel+Carboplatin
Serious events: 19 serious events
Other events: 57 other events
Deaths: 0 deaths
Placebo+Paclitaxel+Carboplatin
Serious events: 13 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ZD4054+Paclitaxel+Carboplatin
n=58 participants at risk
ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
Placebo+Paclitaxel+Carboplatin
n=58 participants at risk
Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
1/58
|
0.00%
0/58
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/58
|
1.7%
1/58
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.00%
0/58
|
1.7%
1/58
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.9%
4/58
|
1.7%
1/58
|
|
Gastrointestinal disorders
Subileus
|
6.9%
4/58
|
0.00%
0/58
|
|
Gastrointestinal disorders
Ileus
|
5.2%
3/58
|
0.00%
0/58
|
|
Gastrointestinal disorders
Constipation
|
3.4%
2/58
|
1.7%
1/58
|
|
Gastrointestinal disorders
Ascites
|
1.7%
1/58
|
1.7%
1/58
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/58
|
1.7%
1/58
|
|
Gastrointestinal disorders
Gastrointestinal Toxicity
|
0.00%
0/58
|
1.7%
1/58
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/58
|
1.7%
1/58
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/58
|
1.7%
1/58
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/58
|
1.7%
1/58
|
|
General disorders
Pyrexia
|
0.00%
0/58
|
3.4%
2/58
|
|
General disorders
General Physical Health Deterioration
|
1.7%
1/58
|
1.7%
1/58
|
|
Immune system disorders
Drug Hypersensitivity
|
8.6%
5/58
|
6.9%
4/58
|
|
Infections and infestations
Escherichia Infection
|
0.00%
0/58
|
1.7%
1/58
|
|
Infections and infestations
Wound Infection
|
1.7%
1/58
|
0.00%
0/58
|
|
Infections and infestations
Haemoglobin Decreased
|
0.00%
0/58
|
1.7%
1/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer Recurrent
|
1.7%
1/58
|
0.00%
0/58
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary Gland Neoplasm
|
0.00%
0/58
|
1.7%
1/58
|
|
Psychiatric disorders
Insomnia
|
1.7%
1/58
|
0.00%
0/58
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
1.7%
1/58
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.7%
1/58
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.7%
1/58
|
0.00%
0/58
|
|
Vascular disorders
Thrombosis
|
1.7%
1/58
|
0.00%
0/58
|
|
Vascular disorders
Vena Cava Thrombosis
|
1.7%
1/58
|
0.00%
0/58
|
Other adverse events
| Measure |
ZD4054+Paclitaxel+Carboplatin
n=58 participants at risk
ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
Placebo+Paclitaxel+Carboplatin
n=58 participants at risk
Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
51.7%
30/58
|
43.1%
25/58
|
|
Blood and lymphatic system disorders
Neutropenia
|
44.8%
26/58
|
37.9%
22/58
|
|
Blood and lymphatic system disorders
Leukopenia
|
34.5%
20/58
|
25.9%
15/58
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.0%
11/58
|
19.0%
11/58
|
|
Ear and labyrinth disorders
Vertigo
|
3.4%
2/58
|
6.9%
4/58
|
|
Eye disorders
Lacrimation Increased
|
5.2%
3/58
|
1.7%
1/58
|
|
Gastrointestinal disorders
Nausea
|
48.3%
28/58
|
53.4%
31/58
|
|
Gastrointestinal disorders
Constipation
|
41.4%
24/58
|
32.8%
19/58
|
|
Gastrointestinal disorders
Vomiting
|
36.2%
21/58
|
34.5%
20/58
|
|
Gastrointestinal disorders
Abdominal Pain
|
27.6%
16/58
|
34.5%
20/58
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
13.8%
8/58
|
20.7%
12/58
|
|
Gastrointestinal disorders
Diarrhoea
|
17.2%
10/58
|
20.7%
12/58
|
|
Gastrointestinal disorders
Stomatitis
|
12.1%
7/58
|
15.5%
9/58
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/58
|
6.9%
4/58
|
|
General disorders
Fatigue
|
34.5%
20/58
|
46.6%
27/58
|
|
General disorders
Asthenia
|
19.0%
11/58
|
29.3%
17/58
|
|
General disorders
Oedema Peripheral
|
22.4%
13/58
|
8.6%
5/58
|
|
General disorders
Mucosal Inflammation
|
15.5%
9/58
|
5.2%
3/58
|
|
General disorders
Pyrexia
|
15.5%
9/58
|
12.1%
7/58
|
|
General disorders
Oedema
|
5.2%
3/58
|
0.00%
0/58
|
|
Immune system disorders
Drug Hypersensitivity
|
25.9%
15/58
|
17.2%
10/58
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
1/58
|
15.5%
9/58
|
|
Infections and infestations
Influenza
|
6.9%
4/58
|
8.6%
5/58
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.1%
7/58
|
3.4%
2/58
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
8.6%
5/58
|
10.3%
6/58
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.3%
6/58
|
32.8%
19/58
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
6/58
|
20.7%
12/58
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.4%
2/58
|
13.8%
8/58
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
5.2%
3/58
|
10.3%
6/58
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
8.6%
5/58
|
3.4%
2/58
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
6.9%
4/58
|
3.4%
2/58
|
|
Nervous system disorders
Headache
|
46.6%
27/58
|
29.3%
17/58
|
|
Nervous system disorders
Paraesthesia
|
19.0%
11/58
|
27.6%
16/58
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
17.2%
10/58
|
22.4%
13/58
|
|
Nervous system disorders
Polyneuropathy
|
3.4%
2/58
|
15.5%
9/58
|
|
Nervous system disorders
Dysgeusia
|
6.9%
4/58
|
13.8%
8/58
|
|
Nervous system disorders
Neuropathy Peripheral
|
10.3%
6/58
|
6.9%
4/58
|
|
Psychiatric disorders
Insomnia
|
5.2%
3/58
|
8.6%
5/58
|
|
Psychiatric disorders
Depression
|
5.2%
3/58
|
0.00%
0/58
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.2%
10/58
|
10.3%
6/58
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
3/58
|
12.1%
7/58
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
6.9%
4/58
|
1.7%
1/58
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.2%
3/58
|
1.7%
1/58
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
48.3%
28/58
|
48.3%
28/58
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
4/58
|
17.2%
10/58
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.3%
6/58
|
3.4%
2/58
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.6%
5/58
|
10.3%
6/58
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
3.4%
2/58
|
6.9%
4/58
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.2%
3/58
|
3.4%
2/58
|
|
Vascular disorders
Hot Flush
|
1.7%
1/58
|
6.9%
4/58
|
|
Vascular disorders
Hypertension
|
1.7%
1/58
|
6.9%
4/58
|
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 to allow for the filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER