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Trial record 1 of 1 for:    D4200C00077
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Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy

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ClinicalTrials.gov Identifier: NCT00777179
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : July 8, 2011
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition NSCLC
Interventions Drug: Vandetanib
Drug: Placebo
Enrollment 117
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description Vandetanib 300 mg, orally, once daily Matching Placebo
Period Title: Overall Study
Started 75 [1] 42 [1]
Completed 75 [2] 42 [2]
Not Completed 0 0
[1]
Number of participants for intent-to-treat (ITT) set population
[2]
All participants' data within ITT set were included for final result.
Arm/Group Title Vandetanib Placebo Total
Hide Arm/Group Description Vandetanib 300 mg, orally, once daily Matching Placebo Total of all reporting groups
Overall Number of Baseline Participants 75 42 117
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Year
Median (min-Max Range) Number Analyzed 75 participants 42 participants 117 participants
61
(33 to 76)
60.5
(29 to 70)
61
(29 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 42 participants 117 participants
Female
28
  37.3%
14
  33.3%
42
  35.9%
Male
47
  62.7%
28
  66.7%
75
  64.1%
Smoking history  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 42 participants 117 participants
Smoker 47 28 75
Non-smoker 28 14 42
Overall response at screening   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 42 participants 117 participants
Partial Response (PR) 44 30 74
Stable Disease (SD) 31 12 43
[1]
Measure Description: completion of 4 cycles of chemotherapy of gemcitabine (1,000mg/m^2/day or 1,250mg/m^2/day on day 1 and 8) and cisplatin (70mg/m^2/day~80mg/m^2/day on day 1) every 3 weeks and have shown responses (CR, PR) or stable disease (SD) by RECIST 1.0.
WHO Performance status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 42 participants 117 participants
0 20 10 30
1 55 32 87
[1]
Measure Description: WHO PS (0: Fully active, able to carry out all usual activities without restrictions and without the aid of analgesia. 1: Restricted in strenuous activity, but ambulatory and able to carry out light work or pursue a sedentary occupation. This group also contains subjects who are fully active, as in grade 0, but only with the aid of analgesics.)
Histology   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 42 participants 117 participants
Adenocarcinoma 56 31 87
Squamous cell carcinoma 11 9 20
Other 8 2 10
[1]
Measure Description: Histology
Classification of lung tumor stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 75 participants 42 participants 117 participants
Stage IIIb 15 12 27
Stage IV 60 30 90
[1]
Measure Description: Classification (Stage IIIb: Any T - N3 - M0 or T4 - Any N - M0, Stage IV: Any T - Any N - M1)
1.Primary Outcome
Title Progression-free Survival (PFS) Rate at 3 Months
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The reported number of participants analyzed (Vandetanib: 63, Placebo: 38) are for PFS evaluable patient set.
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description:
Vandetanib 300 mg, orally, once daily
Matching Placebo
Overall Number of Participants Analyzed 63 38
Measure Type: Number
Unit of Measure: Participants
28 12
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival (PFS) defined as the median time from randomization to death from any cause or first observed disease progression.
Time Frame Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description:
Vandetanib 300 mg, orally, once daily
Matching Placebo
Overall Number of Participants Analyzed 75 42
Median (95% Confidence Interval)
Unit of Measure: months
2.7
(1.9 to 4.4)
1.7
(0.9 to 2.6)
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) defined as the median time from randomization to death from any cause.
Time Frame Every 12 weeks unless the patient withdraws consent
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description:
Vandetanib 300 mg, orally, once daily
Matching Placebo
Overall Number of Participants Analyzed 75 42
Median (95% Confidence Interval)
Unit of Measure: months
15.6 [1] 
(9.6 to NA)
20.8 [1] 
(15.2 to NA)
[1]
no maximum value, observation period for overall survival was not sufficient
4.Secondary Outcome
Title Disease of Response (DOR)
Hide Description

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

Time Frame Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description:
Vandetanib 300 mg, orally, once daily
Matching Placebo
Overall Number of Participants Analyzed 75 42
Measure Type: Number
Unit of Measure: Participants
33 17
5.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description

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.

Time Frame Performed at baseline, every 4 weeks until Week 12 following randomization and then every 8 weeks until objective disease progression.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description:
Vandetanib 300 mg, orally, once daily
Matching Placebo
Overall Number of Participants Analyzed 75 42
Measure Type: Number
Unit of Measure: Participants
14 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vandetanib Placebo
Hide Arm/Group Description Vandetanib 300 mg, orally, once daily Matching Placebo
All-Cause Mortality
Vandetanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   18/75 (24.00%)   4/42 (9.52%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  2/75 (2.67%)  1/42 (2.38%) 
Gastrointestinal disorders     
Diarrhoea  1  3/75 (4.00%)  0/42 (0.00%) 
Dysphagia  1  0/75 (0.00%)  1/42 (2.38%) 
Enterocolitis  1  0/75 (0.00%)  1/42 (2.38%) 
Chest discomfort  2  2/75 (2.67%)  0/42 (0.00%) 
Infections and infestations     
Pneumonia  1  12/75 (16.00%)  1/42 (2.38%) 
Sepsis  1  1/75 (1.33%)  0/42 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  2  1/75 (1.33%)  0/42 (0.00%) 
Nervous system disorders     
Transient ischemic attack  1  3/75 (4.00%)  0/42 (0.00%) 
Headache  1  2/75 (2.67%)  0/42 (0.00%) 
Memory impairment  1  2/75 (2.67%)  0/42 (0.00%) 
Convulsion  1  1/75 (1.33%)  0/42 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Productive cough  1  2/75 (2.67%)  0/42 (0.00%) 
Cough  1  2/75 (2.67%)  0/42 (0.00%) 
Dyspnoea  1  4/75 (5.33%)  0/42 (0.00%) 
Pneumonitis  1  1/75 (1.33%)  0/42 (0.00%) 
pneumothorax  2  2/75 (2.67%)  0/42 (0.00%) 
Ileal perforation  2  1/75 (1.33%)  0/42 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  3/75 (4.00%)  0/42 (0.00%) 
Vascular disorders     
Hypertension  1  2/75 (2.67%)  0/42 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
2
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vandetanib Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   72/75 (96.00%)   37/42 (88.10%) 
Eye disorders     
Vision blurred  2  4/75 (5.33%)  0/42 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  45/75 (60.00%)  4/42 (9.52%) 
Nausea  1  13/75 (17.33%)  6/42 (14.29%) 
Constipation  1  8/75 (10.67%)  2/42 (4.76%) 
Dry Mouth  1  4/75 (5.33%)  0/42 (0.00%) 
Stomatitis  1  8/75 (10.67%)  1/42 (2.38%) 
Vomiting  1  6/75 (8.00%)  1/42 (2.38%) 
General disorders     
Asthenia  1  9/75 (12.00%)  3/42 (7.14%) 
Chest Discomfort  1  7/75 (9.33%)  2/42 (4.76%) 
Chest Pain  1  12/75 (16.00%)  5/42 (11.90%) 
Fatigue  1  5/75 (6.67%)  3/42 (7.14%) 
Mucosal Inflammation  1  7/75 (9.33%)  0/42 (0.00%) 
Pyrexia  1  5/75 (6.67%)  2/42 (4.76%) 
Immune system disorders     
Hypersensitivity  1  0/75 (0.00%)  5/42 (11.90%) 
Infections and infestations     
Paronychia  1  4/75 (5.33%)  0/42 (0.00%) 
Pneumonia  1  9/75 (12.00%)  3/42 (7.14%) 
Metabolism and nutrition disorders     
Anorexia  1  29/75 (38.67%)  7/42 (16.67%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  5/75 (6.67%)  4/42 (9.52%) 
Musculoskeletal Chest Pain  1  1/75 (1.33%)  3/42 (7.14%) 
Musculoskeletal Pain  1  3/75 (4.00%)  5/42 (11.90%) 
Pain in Extremity  1  1/75 (1.33%)  4/42 (9.52%) 
Nervous system disorders     
Dizziness  1  4/75 (5.33%)  3/42 (7.14%) 
Headache  1  8/75 (10.67%)  3/42 (7.14%) 
Peripheral Sensory Neuropathy  1  2/75 (2.67%)  4/42 (9.52%) 
Anxiety  1  5/75 (6.67%)  1/42 (2.38%) 
Psychiatric disorders     
Insomnia  1  14/75 (18.67%)  2/42 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  38/75 (50.67%)  23/42 (54.76%) 
Dyspnoea  1  19/75 (25.33%)  5/42 (11.90%) 
Productive cough  1  29/75 (38.67%)  15/42 (35.71%) 
Dysphonia  1  8/75 (10.67%)  1/42 (2.38%) 
Dyspnoea Exertional  1  7/75 (9.33%)  0/42 (0.00%) 
Haemoptysis  1  5/75 (6.67%)  0/42 (0.00%) 
Pharyngolaryngeal Pain  1  8/75 (10.67%)  2/42 (4.76%) 
Rhinorrhoea  1  3/75 (4.00%)  5/42 (11.90%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  23/75 (30.67%)  7/42 (16.67%) 
Acne  1  9/75 (12.00%)  0/42 (0.00%) 
Dry Skin  1  10/75 (13.33%)  0/42 (0.00%) 
Hyperhidrosis  1  4/75 (5.33%)  0/42 (0.00%) 
Rash  1  58/75 (77.33%)  11/42 (26.19%) 
Skin Lesion  1  8/75 (10.67%)  3/42 (7.14%) 
Vascular disorders     
Flushing  1  6/75 (8.00%)  0/42 (0.00%) 
Hypertension  1  13/75 (17.33%)  0/42 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
2
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00777179     History of Changes
Other Study ID Numbers: D4200C00077
First Submitted: October 21, 2008
First Posted: October 22, 2008
Results First Submitted: April 27, 2011
Results First Posted: July 8, 2011
Last Update Posted: October 10, 2016