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Trial record 1 of 1 for:    D4200C00083
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Addition of Vandetanib to Standard Therapy Pegliposomal Doxorubicin (PLD) (ZACFAST)

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ClinicalTrials.gov Identifier: NCT00862836
Recruitment Status : Terminated (Lack of efficacy)
First Posted : March 17, 2009
Results First Posted : October 11, 2012
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Intervention Drug: Vandetanib
Enrollment 15
Recruitment Details  
Pre-assignment Details

Phase I of the trial consisted of a safety run-in phase of 10 patients with histologically confirmed, epithelial ovarian carcinoma, cancer of the fallopian tube or the peritoneum refractory or partially sensitive to platinum-based therapy evaluable for at least 2 cycles.

Phase II of the trial was not conducted.

Arm/Group Title Vandetanib 100 mg
Hide Arm/Group Description Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
Period Title: Overall Study
Started 15
Evaluable for Safety/Toxicity 14 [1]
Evaluable for Activity (Tumour Response) 10
Completed 14
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
1 patient withdrew consent before first cycle
Arm/Group Title Vandetanib 100 mg
Hide Arm/Group Description Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  80.0%
>=65 years
3
  20.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
15
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs).
Hide Description Number of participants with at least 1 adverse event of grade 3 or higher (CTCAE grade 3=severe, CTCAE grade 4=life threatening/disabling, CTCAE grade 5=death, as defined by National Cancer Institute CTCAE, Version 3)
Time Frame From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg
Hide Arm/Group Description:
Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
9
2.Primary Outcome
Title Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities.
Hide Description Number of patients with elevated liver enzymes grade 3 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).
Time Frame From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg
Hide Arm/Group Description:
Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
3
3.Primary Outcome
Title Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Dermatologic Skin Reactions Grade 3/4.
Hide Description Number of participants with dermatologic skin reactions grade 3/4 (CTCAE grade 3= severe, CTCAE grade 4=life threatening)
Time Frame From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg
Hide Arm/Group Description:
Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
5
4.Primary Outcome
Title Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3/4.
Hide Description Number of participants with palmar-plantar erythrodysesthesia (PPE) grade 3/4 (CTCAE grade 3=severe skin changes with pain, CTCAE grade 4=life threatening).
Time Frame From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg
Hide Arm/Group Description:
Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
5
5.Primary Outcome
Title Description (on the Basis of the Safety Set): Safety and Tolerability by Means of the Incidence and Type of Adverse Events (AEs). Number of Participants With Mucositis Grade 3.
Hide Description Number of participants with mucositis grade 3 (CTCAE grade 3=severe pain interfering with oral intake)
Time Frame From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg
Hide Arm/Group Description:
Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
2
6.Primary Outcome
Title Description (on the Basis of the Safety Set): Safety and Tolerability by Means of Clinically Significant Laboratory Abnormalities. Number of Participants With Neutropenia Grade 3/4.
Hide Description Number of participants with neutropenia grade 3/4 (CTCAE grade 3=severe, CTCAE grade 4=life threatening).
Time Frame From date of registration (Informed Consent Form completed) to date of last vist, up to 18 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg
Hide Arm/Group Description:
Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: Participants
2
7.Secondary Outcome
Title Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Progression Free Survival (PFS).
Hide Description Progression Free Survival: Progression is defined using RECIST, as a measurable increase of at least 20% in the sum of longest diameters of target lesions or unequivocal progression of non-target lesions, or the appearance of new lesions, since baseline.
Time Frame From date of registration (Informed Consent Form completed) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg
Hide Arm/Group Description:
Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: Months
6.7
(0.87 to 13.73)
8.Secondary Outcome
Title Evaluation (for ITT Set): Clinical Activity of Once Daily Oral Vandetanib 100 mg When Added to Standard Therapy (See Above), by Assessment of Overall Survival (OS).
Hide Description Median overall survival (OS)
Time Frame From date of registration (Informed Consent Form completed) until the date of death.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vandetanib 100 mg
Hide Arm/Group Description:
Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
Overall Number of Participants Analyzed 10
Median (95% Confidence Interval)
Unit of Measure: Months
11.1
(2.17 to 14.93)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vandetanib 100 mg
Hide Arm/Group Description Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
All-Cause Mortality
Vandetanib 100 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vandetanib 100 mg
Affected / at Risk (%)
Total   3/14 (21.43%) 
Cardiac disorders   
Arrhythmia  1  1/14 (7.14%) 
Gastrointestinal disorders   
Abdominal pain  1  1/14 (7.14%) 
Ascites  1  1/14 (7.14%) 
Ileus  1  1/14 (7.14%) 
Nausea  1  1/14 (7.14%) 
Vomiting  1  1/14 (7.14%) 
General disorders   
General physical health deterioration  1  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/14 (7.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vandetanib 100 mg
Affected / at Risk (%)
Total   14/14 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  1/14 (7.14%) 
Leukopenia  1  1/14 (7.14%) 
Neutropenia  1  1/14 (7.14%) 
Thrombocytopenia  1  1/14 (7.14%) 
Thrombocytosis  1  1/14 (7.14%) 
Cardiac disorders   
Angina pectoris  1  1/14 (7.14%) 
Tachyarrhythmia  1  1/14 (7.14%) 
Gastrointestinal disorders   
Diarrhoea  1  7/14 (50.00%) 
Nausea  1  7/14 (50.00%) 
Constipation  1  4/14 (28.57%) 
Vomiting  1  4/14 (28.57%) 
Abdominal pain  1  3/14 (21.43%) 
Dyspepsia  1  3/14 (21.43%) 
Stomatitis  1  3/14 (21.43%) 
Dysphagia  1  2/14 (14.29%) 
Oesophagitis  1  2/14 (14.29%) 
Flatulence  1  1/14 (7.14%) 
Gingivitis  1  1/14 (7.14%) 
Oesophageal pain  1  1/14 (7.14%) 
General disorders   
Fatigue  1  6/14 (42.86%) 
Mucosal inflammation  1  6/14 (42.86%) 
Chills  1  1/14 (7.14%) 
Mucosal dryness  1  1/14 (7.14%) 
Oedema peripheral  1  1/14 (7.14%) 
Immune system disorders   
Hypersensitivity  1  1/14 (7.14%) 
Infections and infestations   
Localised infection  1  1/14 (7.14%) 
Nasopharyngitis  1  1/14 (7.14%) 
Urinary tract infection  1  1/14 (7.14%) 
Rhinitis  1  1/14 (7.14%) 
Investigations   
Gamma-glutamyltransferase  1  6/14 (42.86%) 
Aspartate aminotransferase  1  5/14 (35.71%) 
White blood cell count  1  5/14 (35.71%) 
Alanine aminotransferase  1  4/14 (28.57%) 
Blood alkaline phosphatase  1  4/14 (28.57%) 
Blood creatinine  1  3/14 (21.43%) 
Blood lactate dehydrogenase  1  3/14 (21.43%) 
Haemoglobin  1  3/14 (21.43%) 
Blood glucose  1  2/14 (14.29%) 
Monocyte count  1  2/14 (14.29%) 
Protein total  1  2/14 (14.29%) 
Activated partial thromboplastin time  1  1/14 (7.14%) 
Alanine aminotransferase increased  1  1/14 (7.14%) 
Aspartate aminotransferase increased  1  1/14 (7.14%) 
Blood bilirubin  1  1/14 (7.14%) 
Blood calcium  1  1/14 (7.14%) 
Blood chloride  1  1/14 (7.14%) 
Blood glucose increased  1  1/14 (7.14%) 
Blood lactate dehydrogenase increased  1  1/14 (7.14%) 
Blood magnesium decreased  1  1/14 (7.14%) 
Blood potassium  1  1/14 (7.14%) 
Haematocrit  1  1/14 (7.14%) 
Haematocrit decreased  1  1/14 (7.14%) 
Haemoglobin decreased  1  1/14 (7.14%) 
Monocyte count decreased  1  1/14 (7.14%) 
Neutrophil count  1  1/14 (7.14%) 
Neutrophil count increased  1  1/14 (7.14%) 
Prothrombin time  1  1/14 (7.14%) 
International normalised ratio  1  1/14 (7.14%) 
Metabolism and nutrition disorders   
Hypocalcaemia  1  2/14 (14.29%) 
Decreased appetite  1  1/14 (7.14%) 
Hypoglycaemia  1  1/14 (7.14%) 
Hypomagnesaemia  1  1/14 (7.14%) 
Hyponatraemia  1  1/14 (7.14%) 
Hypoproteinaemia  1  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/14 (7.14%) 
Muscle spasms  1  1/14 (7.14%) 
Nervous system disorders   
Headache  1  4/14 (28.57%) 
Peripheral sensory neuropath  1  1/14 (7.14%) 
Psychiatric disorders   
Sleep disorder  1  2/14 (14.29%) 
Insomnia  1  1/14 (7.14%) 
Chromaturia  1  1/14 (7.14%) 
Renal and urinary disorders   
Renal pain  1  1/14 (7.14%) 
Reproductive system and breast disorders   
Breast pain  1  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  3/14 (21.43%) 
Epistaxis  1  2/14 (14.29%) 
Cough  1  1/14 (7.14%) 
Dyspnoea exertional  1  1/14 (7.14%) 
Oropharyngeal pain  1  1/14 (7.14%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysaesthesia syndrome  1  7/14 (50.00%) 
Rash  1  4/14 (28.57%) 
Nail disorder  1  2/14 (14.29%) 
Acne  1  1/14 (7.14%) 
Alopecia  1  1/14 (7.14%) 
Dry skin  1  1/14 (7.14%) 
Eczema  1  1/14 (7.14%) 
Erythema  1  1/14 (7.14%) 
Heat rash  1  1/14 (7.14%) 
Pruritus  1  1/14 (7.14%) 
Skin toxicity  1  1/14 (7.14%) 
Vascular disorders   
Flushing  1  1/14 (7.14%) 
Hot flush  1  1/14 (7.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
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: NCT00862836     History of Changes
Other Study ID Numbers: D4200C00083
2008-005557-38 ( EudraCT Number )
First Submitted: March 16, 2009
First Posted: March 17, 2009
Results First Submitted: November 2, 2011
Results First Posted: October 11, 2012
Last Update Posted: October 10, 2016