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Trial record 23 of 23 for:    Pancreatic Cancer | ( Map: Hong Kong )

A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00428220
Recruitment Status : Completed
First Posted : January 29, 2007
Results First Posted : November 6, 2015
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Metastatic Breast Cancer
Advanced Breast Cancer
Metastatic Castration Resistant Prostate Cancer
Metastatic Renal Cell Cancer
Non-Small Cell Lung Cancer
Thyroid Cancer
Advanced/Metastatic Non-Small Cell Lung Cancer
Advanced Gastric Cancer
Gastrointestinal Stromal Tumor
Hepatocellular Carcinoma
Pancreatic Islet Cell Carcinoma
Pancreatic Neuroendocrine Tumor
Intervention Drug: sunitinib
Enrollment 223
Recruitment Details In this open-label extension study, access to sunitinib was provided to participants who had participated in a previous parent study and who had been judged by the Investigator to have likely clinical benefit from continuing sunitinib dosing.
Pre-assignment Details Participants receiving sunitinib in previous studies began treatment in this study with the last dose they were taking in the parent or extension study. Participants were to continue to access sunitinib on this protocol as long as there was evidence of disease control and/or clinical benefit in the judgment of the Investigator.
Arm/Group Title Sunitinib
Hide Arm/Group Description Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
Period Title: Overall Study
Started 223
Completed 0
Not Completed 223
Reason Not Completed
Participant died             8
Global deterioration of health status             7
Lost to Follow-up             4
Objective progression or relapse             123
Participant refused continued treatment             7
Adverse Event             51
Other             23
Arm/Group Title Sunitinib
Hide Arm/Group Description Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
Overall Number of Baseline Participants 223
Hide Baseline Analysis Population Description
The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 223 participants
55.2  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants
Female
130
  58.3%
Male
93
  41.7%
1.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities)
Hide Description Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.
Time Frame From first day of treatment on the current study up to 28 days post the last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
Overall Number of Participants Analyzed 223
Measure Type: Number
Unit of Measure: participants
Participants with adverse events (AE) 221
Participants with serious adverse events (SAE) 90
Participants with grade 3 or 4 AEs 174
Participants with grade 5 AEs 24
Participants discontinued due to AEs 67
Participants with dose reduction due to AEs 66
Temporary discontinuations due to AEs 146
2.Primary Outcome
Title Number of Participants With Treatment-emergent AEs (Treatment-Related)
Hide Description Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.
Time Frame From first day of treatment on the current study up to 28 days post the last dose of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
Overall Number of Participants Analyzed 223
Measure Type: Number
Unit of Measure: participants
Participants with AE 217
Participants with SAE 39
Participants with grade 3 or 4 AEs 146
Participants with grade 5 AEs 0
Participants discontinued due to AEs 29
Participants with dose reduction due to AEs 64
Temporary discontinuations due to AEs 135
3.Other Pre-specified Outcome
Title Summary of Duration of Clinical Benefit
Hide Description Duration of clinical benefit is defined as the length of time participants remain on sunitinib from the first day of treatment on the parent protocol until the end of sunitinib treatment in this study (A6181114). For participants who were on placebo or a comparator drug in the parent study, duration of clinical benefit is defined as the length of time participants are on sunitinib in this study.
Time Frame From the first day of treatment in parent study until last day of treatment in A6181114 study.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.
Arm/Group Title Sunitinib 1 Sunitinib 2 Sunitinib 3 Sunitinib 4 Sunitinib 5 Sunitinib 6 Sunitinib 7 Sunitinib 8 Sunitinib 9 Sunitinib 10 Sunitinib 11
Hide Arm/Group Description:
Parent Study: A6181078
Parent Study: A6181087
Parent Study: A6181094
Parent Study: A6181107
Parent Study: A6181110
Parent Study: A6181111
Parent Study: A6181112
Parent Study: A6181113
Parent Study: A6181120
Parent Study: A6181126
Parent Study: A6181170
Overall Number of Participants Analyzed 3 1 2 69 38 95 8 1 3 1 2
Mean (Standard Deviation)
Unit of Measure: Weeks
186.6  (68.2) 76.0 [1]   (NA) 157.5  (6.2) 22.1  (25.2) 122.9  (73.4) 76.6  (69.0) 71.6  (26.2) 198.9 [1]   (NA) 142.2  (23.6) 183.6 [1]   (NA) 227.5  (57.9)
[1]
Only one datum, hence no standard deviation.
Time Frame From first day of treatment on the current study up to 28 days post the last dose of study treatment
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Sunitinib
Hide Arm/Group Description Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
All-Cause Mortality
Sunitinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib
Affected / at Risk (%)
Total   90/223 (40.36%) 
Blood and lymphatic system disorders   
Anaemia * 1  5/223 (2.24%) 
Neutropenia * 1  1/223 (0.45%) 
Thrombocytopenia * 1  1/223 (0.45%) 
Cardiac disorders   
Acute coronary syndrome * 1  1/223 (0.45%) 
Acute myocardial infarction * 1  1/223 (0.45%) 
Myocardial infarction * 1  1/223 (0.45%) 
Gastrointestinal disorders   
Abdominal adhesions * 1  1/223 (0.45%) 
Abdominal pain * 1  8/223 (3.59%) 
Abdominal pain upper * 1  2/223 (0.90%) 
Ascites * 1  2/223 (0.90%) 
Diarrhoea * 1  6/223 (2.69%) 
Duodenitis * 1  1/223 (0.45%) 
Gastritis * 1  1/223 (0.45%) 
Gastrointestinal haemorrhage * 1  2/223 (0.90%) 
Haematemesis * 1  2/223 (0.90%) 
Inguinal hernia * 1  1/223 (0.45%) 
Intestinal perforation * 1  1/223 (0.45%) 
Mallory-weiss syndrome * 1  1/223 (0.45%) 
Nausea * 1  3/223 (1.35%) 
Oesophagitis * 1  1/223 (0.45%) 
Pancreatitis * 1  2/223 (0.90%) 
Peritoneal haemorrhage * 1  1/223 (0.45%) 
Pneumatosis intestinalis * 1  1/223 (0.45%) 
Small intestinal obstruction * 1  1/223 (0.45%) 
Subileus * 1  1/223 (0.45%) 
Vomiting * 1  7/223 (3.14%) 
General disorders   
Asthenia * 1  3/223 (1.35%) 
Chest pain * 1  2/223 (0.90%) 
Disease progression * 1  12/223 (5.38%) 
Fatigue * 1  1/223 (0.45%) 
Gait disturbance * 1  1/223 (0.45%) 
General physical health deterioration * 1  5/223 (2.24%) 
Generalised oedema * 1  1/223 (0.45%) 
Mucosal inflammation * 1  1/223 (0.45%) 
Oedema * 1  1/223 (0.45%) 
Pyrexia * 1  5/223 (2.24%) 
Sudden death * 1  1/223 (0.45%) 
Hepatobiliary disorders   
Biliary colic * 1  1/223 (0.45%) 
Cholangitis * 1  1/223 (0.45%) 
Cholecystitis acute * 1  2/223 (0.90%) 
Hepatic failure * 1  1/223 (0.45%) 
Jaundice * 1  2/223 (0.90%) 
Jaundice cholestatic * 1  1/223 (0.45%) 
Infections and infestations   
Bronchitis * 1  1/223 (0.45%) 
Gastroenteritis * 1  1/223 (0.45%) 
Infection * 1  1/223 (0.45%) 
Lymphangitis * 1  1/223 (0.45%) 
Pneumonia * 1  2/223 (0.90%) 
Pneumonia bacterial * 1  1/223 (0.45%) 
Sepsis * 1  1/223 (0.45%) 
Urinary tract infection * 1  2/223 (0.90%) 
Urosepsis * 1  1/223 (0.45%) 
Injury, poisoning and procedural complications   
Joint dislocation * 1  1/223 (0.45%) 
Pelvic fracture * 1  1/223 (0.45%) 
Road traffic accident * 1  1/223 (0.45%) 
Ulna fracture * 1  1/223 (0.45%) 
Investigations   
Alanine aminotransferase increased * 1  1/223 (0.45%) 
Blood calcium increased * 1  1/223 (0.45%) 
Ejection fraction decreased * 1  1/223 (0.45%) 
Weight decreased * 1  1/223 (0.45%) 
Lipase increased * 1  1/223 (0.45%) 
Metabolism and nutrition disorders   
Acidosis * 1  1/223 (0.45%) 
Decreased appetite * 1  3/223 (1.35%) 
Dehydration * 1  2/223 (0.90%) 
Hypoglycaemia * 1  1/223 (0.45%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  4/223 (1.79%) 
Back pain * 1  3/223 (1.35%) 
Flank pain * 1  1/223 (0.45%) 
Intervertebral disc protrusion * 1  1/223 (0.45%) 
Osteonecrosis of jaw * 1  1/223 (0.45%) 
Pain in extremity * 1  1/223 (0.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma * 1  1/223 (0.45%) 
Breast cancer * 1  1/223 (0.45%) 
Chronic myeloid leukaemia * 1  1/223 (0.45%) 
Infected neoplasm * 1  1/223 (0.45%) 
Lymphangiosis carcinomatosa * 1  1/223 (0.45%) 
Prostate cancer * 1  1/223 (0.45%) 
Tumour haemorrhage * 1  1/223 (0.45%) 
Nervous system disorders   
Convulsion * 1  1/223 (0.45%) 
Encephalopathy * 1  1/223 (0.45%) 
Hepatic encephalopathy * 1  1/223 (0.45%) 
Lethargy * 1  1/223 (0.45%) 
Metabolic encephalopathy * 1  1/223 (0.45%) 
Psychiatric disorders   
Confusional state * 1  1/223 (0.45%) 
Depression * 1  1/223 (0.45%) 
Mental status changes * 1  1/223 (0.45%) 
Suicide attempt * 1  1/223 (0.45%) 
Renal and urinary disorders   
Renal failure * 1  1/223 (0.45%) 
Renal failure acute * 1  2/223 (0.90%) 
Reproductive system and breast disorders   
Scrotal erythema * 1  1/223 (0.45%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/223 (0.45%) 
Dyspnoea * 1  3/223 (1.35%) 
Epistaxis * 1  2/223 (0.90%) 
Lung disorder * 1  1/223 (0.45%) 
Pleural effusion * 1  1/223 (0.45%) 
Pneumothorax * 1  2/223 (0.90%) 
Pulmonary embolism * 1  2/223 (0.90%) 
Respiratory failure * 1  1/223 (0.45%) 
Skin and subcutaneous tissue disorders   
Rash * 1  1/223 (0.45%) 
Skin exfoliation * 1  1/223 (0.45%) 
Vascular disorders   
Aortic dissection * 1  1/223 (0.45%) 
Hypertension * 1  1/223 (0.45%) 
Pelvic venous thrombosis * 1  1/223 (0.45%) 
Thrombosis * 1  1/223 (0.45%) 
Venous thrombosis limb * 1  1/223 (0.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib
Affected / at Risk (%)
Total   219/223 (98.21%) 
Blood and lymphatic system disorders   
Anaemia * 1  41/223 (18.39%) 
Leukopenia * 1  35/223 (15.70%) 
Neutropenia * 1  76/223 (34.08%) 
Thrombocytopenia * 1  57/223 (25.56%) 
Endocrine disorders   
Hypothyroidism * 1  24/223 (10.76%) 
Eye disorders   
Lacrimation increased * 1  13/223 (5.83%) 
Gastrointestinal disorders   
Abdominal distention * 1  20/223 (8.97%) 
Abdominal pain * 1  62/223 (27.80%) 
Abdominal pain upper * 1  46/223 (20.63%) 
Constipation * 1  41/223 (18.39%) 
Diarrhoea * 1  142/223 (63.68%) 
Dry mouth * 1  14/223 (6.28%) 
Dyspepsia * 1  36/223 (16.14%) 
Gastritis * 1  13/223 (5.83%) 
Gastrooesophageal reflux disease * 1  14/223 (6.28%) 
Haemorrhoids * 1  13/223 (5.83%) 
Nausea * 1  77/223 (34.53%) 
Stomatitis * 1  39/223 (17.49%) 
Vomiting * 1  61/223 (27.35%) 
General disorders   
Asthenia * 1  67/223 (30.04%) 
Chest pain * 1  14/223 (6.28%) 
Face oedema * 1  17/223 (7.62%) 
Fatigue * 1  83/223 (37.22%) 
Mucosal inflammation * 1  58/223 (26.01%) 
Oedema peripheral * 1  30/223 (13.45%) 
Pain * 1  13/223 (5.83%) 
Pyrexia * 1  26/223 (11.66%) 
Infections and infestations   
Gingivitis * 1  12/223 (5.38%) 
Nasopharyngitis * 1  18/223 (8.07%) 
Upper respiratory tract infection * 1  17/223 (7.62%) 
Investigations   
Alanine aminotransferase increased * 1  21/223 (9.42%) 
Aspartate aminotransferase increased * 1  15/223 (6.73%) 
Blood creatinine increased * 1  13/223 (5.83%) 
Haemoglobin decreased * 1  20/223 (8.97%) 
Neutrophil count decreased * 1  16/223 (7.17%) 
Platelet count decreased * 1  19/223 (8.52%) 
Weight decreased * 1  36/223 (16.14%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  76/223 (34.08%) 
Hyperglycaemia * 1  13/223 (5.83%) 
Hypoalbuminaemia * 1  12/223 (5.38%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  31/223 (13.90%) 
Back pain * 1  47/223 (21.08%) 
Bone pain * 1  12/223 (5.38%) 
Muscle spasms * 1  18/223 (8.07%) 
Myalgia * 1  24/223 (10.76%) 
Pain in extremity * 1  36/223 (16.14%) 
Nervous system disorders   
Dizziness * 1  16/223 (7.17%) 
Dysgeusia * 1  60/223 (26.91%) 
Headache * 1  44/223 (19.73%) 
Psychiatric disorders   
Depression * 1  14/223 (6.28%) 
Insomnia * 1  35/223 (15.70%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  35/223 (15.70%) 
Dyspnoea * 1  44/223 (19.73%) 
Epistaxis * 1  43/223 (19.28%) 
Oropharyngeal pain * 1  19/223 (8.52%) 
Pleural effusion * 1  14/223 (6.28%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  17/223 (7.62%) 
Dry skin * 1  21/223 (9.42%) 
Erythema * 1  19/223 (8.52%) 
Hair colour changes * 1  55/223 (24.66%) 
Hyperkeratosis * 1  13/223 (5.83%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  83/223 (37.22%) 
Rash * 1  30/223 (13.45%) 
Skin discolouration * 1  26/223 (11.66%) 
Yellow skin * 1  22/223 (9.87%) 
Vascular disorders   
Hypertension * 1  64/223 (28.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v17.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00428220     History of Changes
Other Study ID Numbers: A6181114
2006-006538-16 ( EudraCT Number )
First Submitted: January 26, 2007
First Posted: January 29, 2007
Results First Submitted: July 26, 2015
Results First Posted: November 6, 2015
Last Update Posted: June 27, 2019