Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00444795
• Collaborator: (none)
• Enrollment: 520
• Locations: 47
• Duration (Months): 94
• Patients Per Site: 11.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

To monitor use in real practice including adverse events and efficacy on Sutent capsules (Sunitinib malate)

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumors	Drug: Sunitinib malate; Drug: Sunitinib malate; Drug: sunitinib malate

Detailed Description

All the patients prescribed according to approved indications at contracted institutions

Study Design

• Study Type: Observational
• Actual Enrollment: 520 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Sutene
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
1 patients diagnosed as GIST after disease progression on or intolerance to imatinib mesylate	Drug: Sunitinib malate; Sunitinib : dosing not pre-determined
2 patients diagnosed as advanced RCC	Drug: Sunitinib malate; Sunitinib : dosing not pre-determined
3 patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma	Drug: sunitinib malate; Sunitinib : dosing not pre-determined

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs [From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks.]

   An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have had a causal relationship with the treatment or usage. All AEs reported after the start of administration of Sutene were considered as treatment-emergent and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no" (for data that came from Study A6181037), were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.

Secondary Outcome Measures

1. Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to Response Evaluation Criteria in Solid Tumors (RECIST) [At the end of study treatment, average of 23.2 weeks.]

   The antitumor efficacy was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. CR was defined as disappearance of all target and non-target lesions, and no new lesions. PR was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing nontarget lesions, no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients diagnosed as gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, or advanced renal cell carcinoma (aRCC) will be included in the study, or patients diagnosed as unresectable, well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma.

Exclusion Criteria:

• Any patient who does not agree that Pfizer and companies working with Pfizer use his/her information will be excluded.

• Patients with hypersensitivity to sunitinib malate or to any other component of Sutent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keimyung University Dongsan Medical Center	Jung-gu	Daegu	Korea, Republic of	100-712
2	Daegu Catholic University Medical Center	Nam-gu	Daegu	Korea, Republic of	705-718
3	GangNeung Asan Hospital	Gangneung-si	Gangwon-do	Korea, Republic of	210-711
4	Soonchunhyang University Bucheon Hospital	Bucheon	Gyeonggi-do	Korea, Republic of	420-767
5	The Catholic University of Korea, St. Vincent's Hospital	Suwon	Gyeonggi-do	Korea, Republic of	442-723
6	Hwasun Hospital, Chonnam National University	Cheonnam	South Jeolla Province	Korea, Republic of	519-809
7	Hallym University Sacred Heart Hospital	Anyang		Korea, Republic of	431-070
8	Pusan National University Hospital	Busan		Korea, Republic of	602 739
9	Kosin University Gospel Hospital	Busan		Korea, Republic of	602-702
10	Dong-A University Hospital	Busan		Korea, Republic of	602-715
11	Dong-A University Medical Center (Dong-A University Hospital)	Busan		Korea, Republic of	602-715
12	Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology	Busan		Korea, Republic of	602-715
13	Pusan National University Hospital	Busan		Korea, Republic of	602-739
14	Hwasun Hospital, Chonnam National University	Cheonnam		Korea, Republic of	519-809
15	Keimyung University Dongsan Hospital	Daegu		Korea, Republic of	700 712
16	Kyungpook National University Medical Center	Daegu		Korea, Republic of	702-210
17	Daegu Catholic University Medical Center (DCUMC)	Daegu		Korea, Republic of	705-718
18	Chungnam National University Hospital	Daejeon		Korea, Republic of	301-721
19	Eulji University Hospital	Daejeon		Korea, Republic of	302-799
20	Inje University Ilsan Paik Hospital	Goyang		Korea, Republic of	411-706
21	Chosun University Hospital	Gwang Joo		Korea, Republic of	501-717
22	Pusan National University Hospital	Gyeongsangnam-do		Korea, Republic of	626-770
23	Wonkwang University School of Medicine and Hospital (WUH)	Iksan -Si		Korea, Republic of
24	Inha University Hospital	Incheon		Korea, Republic of	400-711
25	Gachon University Gil Hospital	Incheon		Korea, Republic of	405-760
26	Chonbuk National University Hospital	Jeonju		Korea, Republic of	561-712
27	Yeungnam University Medical Center	Nam-gu		Korea, Republic of	705-717
28	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	463-707
29	Seoul National University Hospital (SNUH)	Seoul		Korea, Republic of	110-744
30	Seoul National University Hospital / Department of Internal Medicine	Seoul		Korea, Republic of	110-744
31	Kangbuk Samsung Hospital	Seoul		Korea, Republic of	110-746
32	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	120-752
33	Kyung Hee University Medical Center	Seoul		Korea, Republic of	130-872
34	KyungHee University Medical Center	Seoul		Korea, Republic of	130-872
35	Samsung Medical Center, Dept. of Medicine, Div. of Hematology/Oncology	Seoul		Korea, Republic of	135-710
36	Samsung Medical Center/Division of Hematology-Oncology, Department of Medicine	Seoul		Korea, Republic of	135-710
37	Gangnam Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	135-720
38	Korea University Anam Hospital	Seoul		Korea, Republic of	136-705
39	Asan Medical Center/Department of Oncology	Seoul		Korea, Republic of	138-736
40	Asan Medical Center	Seoul		Korea, Republic of	138-736
41	Korea Cancer Center Hospital	Seoul		Korea, Republic of	139-706
42	Korea University Guro Hospital	Seoul		Korea, Republic of	152-703
43	Ewha Womans University Mokdong Hospital	Seoul		Korea, Republic of	158-710
44	Seoul National University Hospital	Seoul		Korea, Republic of	3080
45	Seoul ST. Mary's Hospital	Seoul		Korea, Republic of
46	Ulsan University Hospital	Ulsan		Korea, Republic of	682-714
47	Yonsei University Wonju College of Medicine, Wonju Christian Hospital	Wonju-si		Korea, Republic of	220-701

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00444795
• Other Study ID Numbers: A6181146
• First Posted: Mar 8, 2007
• Last Update Posted: Feb 1, 2017
• Last Verified: Dec 1, 2016

• Keywords provided by Pfizer: SUTENE; post-marketing surveillance; GIST; RCC; Korea
• Additional relevant MeSH terms: Gastrointestinal Stromal Tumors; Sunitinib

Study Results

Participant Flow

Recruitment Details	This post marketing surveillance (PMS) study enrolled 520 participants between December 2007 and March 2015. Data from 100 participants were obtained from a previously completed study (A6181037).

Arm/Group Title	Sutene
Arm/Group Description	Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Period Title: Overall Study
STARTED	620
COMPLETED	617
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Sutene
Arm/Group Description	Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Overall Participants	617
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	57.94 (11.29)
Gender (Count of Participants)
Female	149 24.1%
Male	468 75.9%
Diagnosis (Number) [Number]
Advanced Renal Cell Carcinoma	550 89.1%
Gastrointestinal Stromal Tumor	64 10.4%
Progressive Pancreatic Neuroendocrine Carcinoma	2 0.3%
Data Missing	1 0.2%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), Unexpected AEs/ADRs, and Unexpected SAEs/SADRs
Description	An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have had a causal relationship with the treatment or usage. All AEs reported after the start of administration of Sutene were considered as treatment-emergent and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely" or "no" (for data that came from Study A6181037), were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer.
Time Frame	From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks.

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	Sutene
Arm/Group Description	Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Measure Participants	617
AEs	80.23 13%
ADRs	76.50 12.4%
SAEs	11.67 1.9%
SADRs	7.46 1.2%
Unexpected AEs	44.57 7.2%
Unexpected ADRs	35.17 5.7%
Unexpected SAEs	6.32 1%
Unexpected SADRs	2.76 0.4%

2. Secondary Outcome

Title	Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to Response Evaluation Criteria in Solid Tumors (RECIST)
Description	The antitumor efficacy was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. CR was defined as disappearance of all target and non-target lesions, and no new lesions. PR was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing nontarget lesions, no new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.
Time Frame	At the end of study treatment, average of 23.2 weeks.

Outcome Measure Data

Analysis Population Description

Intent-to-treat Analysis Set: Participants who administered Sutene at least once.

Arm/Group Title	Sutene
Arm/Group Description	Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
Measure Participants	515
Number (95% Confidence Interval) [Percentage of Participants]	77.48 12.6%

Adverse Events

Time Frame	From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug, average of 27.2 weeks.
Adverse Event Reporting Description	The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Sutene
Arm/Group Description	Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
All Cause Mortality
	Sutene
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sutene
	Affected / at Risk (%)	# Events
Total	72/617 (11.7%)
Blood and lymphatic system disorders
Disseminated intravascular coagulation	1/617 (0.2%)
Purpura thrombopenic thrombotic	1/617 (0.2%)
Thrombocytopenia	8/617 (1.3%)
Anaemia	1/617 (0.2%)
Haemolytic-uraemic syndrome	1/617 (0.2%)
Leukocytosis	1/617 (0.2%)
Cardiac disorders
Cardiac failure	2/617 (0.3%)
Cardiomegaly	1/617 (0.2%)
Congestive heart failure	1/617 (0.2%)
Myocardial infarction	1/617 (0.2%)
Pericardial effusion	1/617 (0.2%)
Endocrine disorders
hypothyroidism	1/617 (0.2%)
Eye disorders
Conjunctivitis	1/617 (0.2%)
Gastrointestinal disorders
Abdomen enlarged	1/617 (0.2%)
Abdominal pain	4/617 (0.6%)
Appendicitis	1/617 (0.2%)
Colitis	3/617 (0.5%)
Diarrhoea	4/617 (0.6%)
Haematemesis	1/617 (0.2%)
Haemorrhage rectum	1/617 (0.2%)
Hiccup	1/617 (0.2%)
Ileus	1/617 (0.2%)
Intestinal fistula	1/617 (0.2%)
Melaena	2/617 (0.3%)
Nausea	1/617 (0.2%)
Oesophagitis	1/617 (0.2%)
Pancreatitis	1/617 (0.2%)
Vomiting	3/617 (0.5%)
General disorders
Ascites	1/617 (0.2%)
Asthenia	14/617 (2.3%)
Condition aggravated	5/617 (0.8%)
Death	2/617 (0.3%)
Fatigue	1/617 (0.2%)
Fever	2/617 (0.3%)
Oedema	1/617 (0.2%)
Pain	1/617 (0.2%)
Systemic inflammatory response syndrome	1/617 (0.2%)
Hepatobiliary disorders
Bilirubinaemia	1/617 (0.2%)
Cholecystitis	2/617 (0.3%)
Hepatorenal syndrome	1/617 (0.2%)
Jaundice	1/617 (0.2%)
Infections and infestations
Infection	1/617 (0.2%)
Sepsis	3/617 (0.5%)
Injury, poisoning and procedural complications
Laceration	1/617 (0.2%)
Post-operative wound infection	1/617 (0.2%)
Metabolism and nutrition disorders
Hypercalcaemia	1/617 (0.2%)
Hyperkalaemia	1/617 (0.2%)
Hypoglycaemia	2/617 (0.3%)
Hyponatraemia	1/617 (0.2%)
Malnutrition	2/617 (0.3%)
Musculoskeletal and connective tissue disorders
Back pain	1/617 (0.2%)
Muscle weakness	2/617 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma of oesophagus	1/617 (0.2%)
Gastric carcinoma	1/617 (0.2%)
Neoplasm malignant	1/617 (0.2%)
Pulmonary carcinoma	1/617 (0.2%)
Nervous system disorders
Anorexia	1/617 (0.2%)
Convulsions	1/617 (0.2%)
Dizziness	2/617 (0.3%)
Headache	1/617 (0.2%)
Paralysis	1/617 (0.2%)
Psychiatric disorders
Confusion	1/617 (0.2%)
Delirium	1/617 (0.2%)
Mental deficiency	2/617 (0.3%)
Renal and urinary disorders
Azotaemia	1/617 (0.2%)
Haematuria	1/617 (0.2%)
Renal failure acute	5/617 (0.8%)
Urinary tract infection	2/617 (0.3%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	7/617 (1.1%)
Haemoptysis	2/617 (0.3%)
Pleural effusion	3/617 (0.5%)
Pneumothorax	1/617 (0.2%)
Pneumonia	8/617 (1.3%)
Skin and subcutaneous tissue disorders
Dermatitis	1/617 (0.2%)
Surgical and medical procedures
Surgical intervention	1/617 (0.2%)
Vascular disorders
Circulatory failure	2/617 (0.3%)
Hypertension	2/617 (0.3%)
Hypotension	1/617 (0.2%)
Shock septic	1/617 (0.2%)
Haemorrhage intracranial	1/617 (0.2%)
Haemorrhage nos	1/617 (0.2%)
Thromboembolism	1/617 (0.2%)
Thrombophlebitis deep	1/617 (0.2%)
Other (Not Including Serious) Adverse Events
	Sutene
	Affected / at Risk (%)	# Events
Total	474/617 (76.8%)
Blood and lymphatic system disorders
Thrombocytopenia	137/617 (22.2%)
Granulocytopenia	113/617 (18.3%)
Leucopenia	44/617 (7.1%)
Endocrine disorders
Hypothyroidism	44/617 (7.1%)
Gastrointestinal disorders
Abdominal pain	95/617 (15.4%)
Constipation	50/617 (8.1%)
Diarrhoea	137/617 (22.2%)
Dyspepsia	66/617 (10.7%)
Mucositis nos	115/617 (18.6%)
Nausea	92/617 (14.9%)
Stomatitis	145/617 (23.5%)
Vomiting	64/617 (10.4%)
General disorders
Asthenia	82/617 (13.3%)
Chest pain	34/617 (5.5%)
Face oedema	82/617 (13.3%)
Fatigue	109/617 (17.7%)
Fever	32/617 (5.2%)
Oedema	38/617 (6.2%)
Oedema periorbital	45/617 (7.3%)
Palmar-plantar erythrodysaesthesia	191/617 (31%)
Hepatobiliary disorders
Jaundice	72/617 (11.7%)
Serum glutamic-oxaloacetic transaminase increased	44/617 (7.1%)
Serum glutamate pyruvate transaminase increased	32/617 (5.2%)
Musculoskeletal and connective tissue disorders
Back pain	67/617 (10.9%)
Myalgia	37/617 (6%)
Nervous system disorders
Anorexia	159/617 (25.8%)
Dizziness	31/617 (5%)
Headache	50/617 (8.1%)
Renal and urinary disorders
Azotaemia	35/617 (5.7%)
Respiratory, thoracic and mediastinal disorders
Coughing	33/617 (5.3%)
Dyspnoea	47/617 (7.6%)
Epistaxis	48/617 (7.8%)
Pharyngitis	44/617 (7.1%)
Skin and subcutaneous tissue disorders
Rash	80/617 (13%)
Vascular disorders
Hypertension	59/617 (9.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.