Trial Outcomes & Findings for Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy (NCT NCT00777179)
NCT ID: NCT00777179
Last Updated: 2016-10-10
Results Overview
Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
117 participants
Primary outcome timeframe
12 weeks
Results posted on
2016-10-10
Participant Flow
First patient enrolled: 13 October 2008 Last patient enrolled: 7 December 2009 This study was conducted at Division of oncology, Department of Medicine of general hospitals in Korea.
Participant milestones
| Measure |
Vandetanib
Vandetanib 300 mg, orally, once daily
|
Placebo
Matching Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
42
|
|
Overall Study
COMPLETED
|
75
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy
Baseline characteristics by cohort
| Measure |
Vandetanib
n=75 Participants
Vandetanib 300 mg, orally, once daily
|
Placebo
n=42 Participants
Matching Placebo
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Median (min-Max Range)
|
61 year
n=93 Participants
|
60.5 year
n=4 Participants
|
61 year
n=27 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Smoking history
Smoker
|
47 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Smoking history
Non-smoker
|
28 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Overall response at screening
Partial Response (PR)
|
44 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Overall response at screening
Stable Disease (SD)
|
31 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
WHO Performance status
0
|
20 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
WHO Performance status
1
|
55 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
|
Histology
Adenocarcinoma
|
56 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
|
Histology
Squamous cell carcinoma
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Histology
Other
|
8 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Classification of lung tumor stage
Stage IIIb
|
15 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Classification of lung tumor stage
Stage IV
|
60 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
90 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The reported number of participants analyzed (Vandetanib: 63, Placebo: 38) are for PFS evaluable patient set.
Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.
Outcome measures
| Measure |
Vandetanib
n=63 Participants
Vandetanib 300 mg, orally, once daily
|
Placebo
n=38 Participants
Matching Placebo
|
|---|---|---|
|
Progression-free Survival (PFS) Rate at 3 Months
|
28 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression.
Outcome measures
| Measure |
Vandetanib
n=75 Participants
Vandetanib 300 mg, orally, once daily
|
Placebo
n=42 Participants
Matching Placebo
|
|---|---|---|
|
Progression-free Survival (PFS)
|
2.7 months
Interval 1.9 to 4.4
|
1.7 months
Interval 0.9 to 2.6
|
SECONDARY outcome
Timeframe: Every 12 weeks unless the patient withdraws consentOverall survival (OS) defined as the median time from randomization to death from any cause.
Outcome measures
| Measure |
Vandetanib
n=75 Participants
Vandetanib 300 mg, orally, once daily
|
Placebo
n=42 Participants
Matching Placebo
|
|---|---|---|
|
Overall Survival (OS)
|
15.6 months
Interval 9.6 to
no maximum value, observation period for overall survival was not sufficient
|
20.8 months
Interval 15.2 to
no maximum value, observation period for overall survival was not sufficient
|
SECONDARY outcome
Timeframe: Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.Number of patients showing Complete Response (CR), Partial Response (PR) or Stable Disease (SD) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions), Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) or Stable Disease (SD, Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum longest diameter since the treatment started) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response
Outcome measures
| Measure |
Vandetanib
n=75 Participants
Vandetanib 300 mg, orally, once daily
|
Placebo
n=42 Participants
Matching Placebo
|
|---|---|---|
|
Disease of Response (DOR)
|
33 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.Number of patients showing Complete Response (CR) or Partial Response (PR) based on RECIST for the best response. Number of patients showing Complete Response (CR, disappearance of all target lesions) or Partial Response (PR, at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter) based on RECIST Criteria Version 1.0 (assessed by CT and/or MRI) for the best response.
Outcome measures
| Measure |
Vandetanib
n=75 Participants
Vandetanib 300 mg, orally, once daily
|
Placebo
n=42 Participants
Matching Placebo
|
|---|---|---|
|
Objective Response Rate (ORR)
|
14 Participants
|
1 Participants
|
Adverse Events
Vandetanib
Serious events: 18 serious events
Other events: 72 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vandetanib
n=75 participants at risk
Vandetanib 300 mg, orally, once daily
|
Placebo
n=42 participants at risk
Matching Placebo
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
16.0%
12/75
|
2.4%
1/42
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
3/75
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
3/75
|
0.00%
0/42
|
|
Nervous system disorders
Transient ischemic attack
|
4.0%
3/75
|
0.00%
0/42
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.7%
2/75
|
2.4%
1/42
|
|
Nervous system disorders
Headache
|
2.7%
2/75
|
0.00%
0/42
|
|
Vascular disorders
Hypertension
|
2.7%
2/75
|
0.00%
0/42
|
|
Nervous system disorders
Memory impairment
|
2.7%
2/75
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.7%
2/75
|
0.00%
0/42
|
|
Nervous system disorders
Convulsion
|
1.3%
1/75
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
2/75
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
4/75
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.3%
1/75
|
0.00%
0/42
|
|
Infections and infestations
Sepsis
|
1.3%
1/75
|
0.00%
0/42
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/75
|
2.4%
1/42
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/75
|
2.4%
1/42
|
|
Gastrointestinal disorders
Chest discomfort
|
2.7%
2/75
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
2.7%
2/75
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Ileal perforation
|
1.3%
1/75
|
0.00%
0/42
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.3%
1/75
|
0.00%
0/42
|
Other adverse events
| Measure |
Vandetanib
n=75 participants at risk
Vandetanib 300 mg, orally, once daily
|
Placebo
n=42 participants at risk
Matching Placebo
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.3%
4/75
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
Rash
|
77.3%
58/75
|
26.2%
11/42
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
10.7%
8/75
|
7.1%
3/42
|
|
Vascular disorders
Hypertension
|
17.3%
13/75
|
0.00%
0/42
|
|
Eye disorders
Vision blurred
|
5.3%
4/75
|
0.00%
0/42
|
|
General disorders
Chest Discomfort
|
9.3%
7/75
|
4.8%
2/42
|
|
General disorders
Chest Pain
|
16.0%
12/75
|
11.9%
5/42
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.7%
8/75
|
2.4%
1/42
|
|
General disorders
Fatigue
|
6.7%
5/75
|
7.1%
3/42
|
|
General disorders
Mucosal Inflammation
|
9.3%
7/75
|
0.00%
0/42
|
|
General disorders
Pyrexia
|
6.7%
5/75
|
4.8%
2/42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
9.3%
7/75
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.7%
5/75
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
10.7%
8/75
|
4.8%
2/42
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.0%
3/75
|
11.9%
5/42
|
|
Skin and subcutaneous tissue disorders
Acne
|
12.0%
9/75
|
0.00%
0/42
|
|
Vascular disorders
Flushing
|
8.0%
6/75
|
0.00%
0/42
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
13.3%
10/75
|
0.00%
0/42
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/75
|
11.9%
5/42
|
|
Infections and infestations
Paronychia
|
5.3%
4/75
|
0.00%
0/42
|
|
Infections and infestations
Pneumonia
|
12.0%
9/75
|
7.1%
3/42
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.7%
5/75
|
9.5%
4/42
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
1.3%
1/75
|
7.1%
3/42
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
4.0%
3/75
|
11.9%
5/42
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.3%
1/75
|
9.5%
4/42
|
|
Nervous system disorders
Dizziness
|
5.3%
4/75
|
7.1%
3/42
|
|
Nervous system disorders
Headache
|
10.7%
8/75
|
7.1%
3/42
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
2.7%
2/75
|
9.5%
4/42
|
|
Nervous system disorders
Anxiety
|
6.7%
5/75
|
2.4%
1/42
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
45/75
|
9.5%
4/42
|
|
Gastrointestinal disorders
Nausea
|
17.3%
13/75
|
14.3%
6/42
|
|
Metabolism and nutrition disorders
Anorexia
|
38.7%
29/75
|
16.7%
7/42
|
|
Psychiatric disorders
Insomnia
|
18.7%
14/75
|
4.8%
2/42
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.7%
38/75
|
54.8%
23/42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.3%
19/75
|
11.9%
5/42
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
38.7%
29/75
|
35.7%
15/42
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.7%
23/75
|
16.7%
7/42
|
|
Gastrointestinal disorders
Constipation
|
10.7%
8/75
|
4.8%
2/42
|
|
Gastrointestinal disorders
Dry Mouth
|
5.3%
4/75
|
0.00%
0/42
|
|
Gastrointestinal disorders
Stomatitis
|
10.7%
8/75
|
2.4%
1/42
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
6/75
|
2.4%
1/42
|
|
General disorders
Asthenia
|
12.0%
9/75
|
7.1%
3/42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER