Rollover Protocol for Prior SU011248 Protocols

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00798889
• Collaborator: (none)
• Enrollment: 314
• Locations: 59
• Arm: 1
• Duration (Months): 93
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol

Condition or Disease	Intervention/Treatment	Phase
Solid Tumors	Drug: Sunitinib	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 314 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol
• Study Start Date: Mar 1, 2004
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sunitinib	Drug: Sunitinib; Sunitinib dose varies according to the doses allowed in previous protocol. It is given once a day, orally with various schedules depending on the parent protocol

Outcome Measures

Primary Outcome Measures

1. Duration of Treatment [Baseline up to Day 28 after last dose of study treatment]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Prior SU011248 Protocol.

• Eligible to continue SU011248 treatment.

Exclusion Criteria:

• Uncontrolled CNS metastasis.

• Unfit to receive SU011248.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Birmingham	Alabama	United States	35233-2115
2	Pfizer Investigational Site	Birmingham	Alabama	United States	35233
3	Pfizer Investigational Site	Birmingham	Alabama	United States	35294
4	Pfizer Investigational Site	Los Angeles	California	United States	90033
5	Pfizer Investigational Site	Los Angeles	California	United States	90095
6	Pfizer Investigational Site	San Francisco	California	United States	94115-1705
7	Pfizer Investigational Site	San Francisco	California	United States	94115
8	Pfizer Investigational Site	Santa Monica,	California	United States	90404
9	Pfizer Investigational Site	Aurora	Colorado	United States	80045
10	Pfizer Investigational Site	Indianapolis	Indiana	United States	46202
11	Pfizer Investigational Site	Boston	Massachusetts	United States	02114
12	Pfizer Investigational Site	Boston	Massachusetts	United States	02115
13	Pfizer Investigational Site	Boston	Massachusetts	United States	02215
14	Pfizer Investigational Site	Ann Arbor	Michigan	United States	48109-0843
15	Pfizer Investigational Site	Detroit	Michigan	United States	48201
16	Pfizer Investigational Site	Farmington Hills	Michigan	United States	48334
17	Pfizer Investigational Site	Minneapolis	Minnesota	United States	55455-0392
18	Pfizer Investigational Site	St. Louis	Missouri	United States	63110
19	Pfizer Investigational Site	Albuquerque	New Mexico	United States	87131-0001
20	Pfizer Investigational Site	Albuqurque	New Mexico	United States	87106
21	Pfizer Investigational Site	New York	New York	United States	10021
22	Pfizer Investigational Site	New York	New York	United States	10022
23	Pfizer Investigational Site	New York	New York	United States	10032
24	Pfizer Investigational Site	Durham	North Carolina	United States	27710
25	Pfizer Investigational Site	Cleveland	Ohio	United States	44195
26	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19111
27	Pfizer Investigational Site	Myrtle Beach	South Carolina	United States	29572
28	Pfizer Investigational Site	Franklin	Tennessee	United States	37067
29	Pfizer Investigational Site	Gallatin	Tennessee	United States	37066
30	Pfizer Investigational Site	Hermitage	Tennessee	United States	37076
31	Pfizer Investigational Site	Lebanon	Tennessee	United States	37087
32	Pfizer Investigational Site	Murfreesboro	Tennessee	United States	37130
33	Pfizer Investigational Site	Nashville	Tennessee	United States	37203
34	Pfizer Investigational Site	Nashville	Tennessee	United States	37205
35	Pfizer Investigational Site	Nashville	Tennessee	United States	37207
36	Pfizer Investigational Site	Nashville	Tennessee	United States	37211
37	Pfizer Investigational Site	Nashville	Tennessee	United States	37212
38	Pfizer Investigational Site	Nashville	Tennessee	United States	37232
39	Pfizer Investigational Site	Smyrna	Tennessee	United States	37167
40	Pfizer Investigational Site	Dallas	Texas	United States	75246
41	Pfizer Investigational Site	Houston	Texas	United States	77030-4009
42	Pfizer Investigational Site	Madison	Wisconsin	United States	53792
43	Pfizer Investigational Site	Randwick	New South Wales	Australia	2031
44	Pfizer Investigational Site	East Melbourne	Victoria	Australia	3002
45	Pfizer Investigational Site	Heidelberg	Victoria	Australia	3084
46	Pfizer Investigational Site	Montreal	Quebec	Canada	H2L 4M1
47	Pfizer Investigational Site	Villejuif Cedex		France	94805
48	Pfizer Investigational Site	Thessaloniki		Greece	564 03
49	Pfizer Investigational Site	Milano		Italy	20133
50	Pfizer Investigational Site	Milano		Italy	20141
51	Pfizer Investigational Site	Nijmegen	Gld	Netherlands	6525 GA
52	Pfizer Investigational Site	Singapore		Singapore	308433
53	Pfizer Investigational Site	Lund		Sweden
54	Pfizer Investigational Site	Stockholm		Sweden
55	Pfizer Investigational Site	St. Gallen		Switzerland	CH-9007
56	Pfizer Investigational Site	Leeds		United Kingdom	LS9 7TF
57	Pfizer Investigational Site	London		United Kingdom	NW1 2PG
58	Pfizer Investigational Site	London		United Kingdom	SW3 6JJ
59	Pfizer Investigational Site	Newcastle-Upon-Tyne		United Kingdom	NE4 6BE

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: NCT00798889
• Other Study ID Numbers: A6181030; NCT00569725
• First Posted: Nov 26, 2008
• Last Update Posted: Jan 21, 2013
• Last Verified: Dec 1, 2012

• Keywords provided by Pfizer: Solid tumors
• Additional relevant MeSH terms: Sunitinib

Study Results

Participant Flow

Recruitment Details	Participants were recruited from prior studies in which they received sunitinib.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 50 milligram (mg) capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator's discretion.
Period Title: Overall Study
STARTED	314
Treated	311
COMPLETED	0
NOT COMPLETED	314

Baseline Characteristics

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator's discretion.
Overall Participants	311
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	58.5 (11.62)
Sex: Female, Male (Count of Participants)
Female	113 36.3%
Male	198 63.7%

Outcome Measures

1. Primary Outcome

Title	Duration of Treatment
Time Frame	Baseline up to Day 28 after last dose of study treatment

Outcome Measure Data

Analysis Population Description

The intent-to-treat population included all participants who were enrolled in the study and received at least 1 dose of study medication.

Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator's discretion.
Measure Participants	311
Median (Full Range) [Days]	190

Adverse Events

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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Sunitinib
Arm/Group Description	Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator's discretion.
All Cause Mortality
	Sunitinib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sunitinib
	Affected / at Risk (%)	# Events
Total	118/311 (37.9%)
Blood and lymphatic system disorders
Anaemia	8/311 (2.6%)
Disseminated intravascular coagulation	1/311 (0.3%)
Febrile neutropenia	1/311 (0.3%)
Neutropenia	1/311 (0.3%)
Cardiac disorders
Arrhythmia	2/311 (0.6%)
Cardiac failure congestive	2/311 (0.6%)
Myocardial infarction	2/311 (0.6%)
Arrhythmia supraventricular	1/311 (0.3%)
Atrial fibrillation	1/311 (0.3%)
Atrioventricular block first degree	1/311 (0.3%)
Cardiac failure	1/311 (0.3%)
Cardio-respiratory arrest	1/311 (0.3%)
Sinus bradycardia	1/311 (0.3%)
Gastrointestinal disorders
Abdominal pain	14/311 (4.5%)
Vomiting	11/311 (3.5%)
Nausea	10/311 (3.2%)
Diarrhoea	7/311 (2.3%)
Pancreatitis	5/311 (1.6%)
Gastrointestinal haemorrhage	4/311 (1.3%)
Abdominal pain upper	2/311 (0.6%)
Upper gastrointestinal haemorrhage	2/311 (0.6%)
Abdominal pain lower	1/311 (0.3%)
Caecitis	1/311 (0.3%)
Cyclic vomiting syndrome	1/311 (0.3%)
Enterocutaneous fistula	1/311 (0.3%)
Gastric haemorrhage	1/311 (0.3%)
Gastrointestinal fistula	1/311 (0.3%)
Gastrointestinal obstruction	1/311 (0.3%)
Haematemesis	1/311 (0.3%)
Haematochezia	1/311 (0.3%)
Ileus	1/311 (0.3%)
Intestinal perforation	1/311 (0.3%)
Large intestine perforation	1/311 (0.3%)
Melaena	1/311 (0.3%)
Proctalgia	1/311 (0.3%)
Rectal haemorrhage	1/311 (0.3%)
Rectal obstruction	1/311 (0.3%)
Retching	1/311 (0.3%)
Small intestinal obstruction	1/311 (0.3%)
General disorders
Disease progression	9/311 (2.9%)
Pyrexia	6/311 (1.9%)
Chest pain	4/311 (1.3%)
Asthenia	2/311 (0.6%)
Fatigue	2/311 (0.6%)
Adverse drug reaction	1/311 (0.3%)
Chest discomfort	1/311 (0.3%)
Pain	1/311 (0.3%)
Sudden death	1/311 (0.3%)
Hepatobiliary disorders
Cholecystitis	4/311 (1.3%)
Hepatic failure	4/311 (1.3%)
Cholangitis	2/311 (0.6%)
Bile duct stone	1/311 (0.3%)
Biliary fistula	1/311 (0.3%)
Cholecystitis acute	1/311 (0.3%)
Cholelithiasis	1/311 (0.3%)
Hepatic haemorrhage	1/311 (0.3%)
Hepatitis	1/311 (0.3%)
Hyperbilirubinaemia	1/311 (0.3%)
Portal vein thrombosis	1/311 (0.3%)
Infections and infestations
Pneumonia	5/311 (1.6%)
Sepsis	4/311 (1.3%)
Infection	3/311 (1%)
Urinary tract infection	3/311 (1%)
Cellulitis	2/311 (0.6%)
Liver abscess	2/311 (0.6%)
Wound infection	2/311 (0.6%)
Abdominal abscess	1/311 (0.3%)
Bronchitis	1/311 (0.3%)
Clostridial infection	1/311 (0.3%)
Empyema	1/311 (0.3%)
Enterocolitis infectious	1/311 (0.3%)
Gastroenteritis	1/311 (0.3%)
Gastroenteritis viral	1/311 (0.3%)
Infectious peritonitis	1/311 (0.3%)
Klebsiella bacteraemia	1/311 (0.3%)
Lower respiratory tract infection	1/311 (0.3%)
Muscle abscess	1/311 (0.3%)
Pancreatic abscess	1/311 (0.3%)
Perirectal abscess	1/311 (0.3%)
Pyelonephritis	1/311 (0.3%)
Septic shock	1/311 (0.3%)
Injury, poisoning and procedural complications
Acetabulum fracture	1/311 (0.3%)
Concussion	1/311 (0.3%)
Fall	1/311 (0.3%)
Femur fracture	1/311 (0.3%)
Humerus fracture	1/311 (0.3%)
Limb injury	1/311 (0.3%)
Pelvic fracture	1/311 (0.3%)
Pubis fracture	1/311 (0.3%)
Transfusion reaction	1/311 (0.3%)
Wound complication	1/311 (0.3%)
Investigations
Aspartate aminotransferase increased	1/311 (0.3%)
Blood bilirubin increased	1/311 (0.3%)
Haemoglobin decreased	1/311 (0.3%)
Weight decreased	1/311 (0.3%)
Metabolism and nutrition disorders
Dehydration	13/311 (4.2%)
Failure to thrive	1/311 (0.3%)
Hypercalcaemia	1/311 (0.3%)
Hyperkalaemia	1/311 (0.3%)
Hypernatraemia	1/311 (0.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/311 (0.6%)
Back pain	2/311 (0.6%)
Bursitis	1/311 (0.3%)
Flank pain	1/311 (0.3%)
Neck pain	1/311 (0.3%)
Pain in extremity	1/311 (0.3%)
Pathological fracture	1/311 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage	2/311 (0.6%)
Gastrointestinal stromal tumour	1/311 (0.3%)
Squamous cell carcinoma of skin	1/311 (0.3%)
Nervous system disorders
Convulsion	2/311 (0.6%)
Hepatic encephalopathy	2/311 (0.6%)
Spinal cord compression	2/311 (0.6%)
Syncope	2/311 (0.6%)
Cerebral haemorrhage	1/311 (0.3%)
Cognitive disorder	1/311 (0.3%)
Depressed level of consciousness	1/311 (0.3%)
Dizziness	1/311 (0.3%)
Grand mal convulsion	1/311 (0.3%)
Headache	1/311 (0.3%)
Ischaemic stroke	1/311 (0.3%)
Paraplegia	1/311 (0.3%)
Presyncope	1/311 (0.3%)
Transient ischaemic attack	1/311 (0.3%)
Psychiatric disorders
Mental status changes	3/311 (1%)
Confusional state	2/311 (0.6%)
Depression	1/311 (0.3%)
Renal and urinary disorders
Renal failure	3/311 (1%)
Renal failure acute	2/311 (0.6%)
Hydronephrosis	1/311 (0.3%)
Incontinence	1/311 (0.3%)
Renal impairment	1/311 (0.3%)
Urinary retention	1/311 (0.3%)
Reproductive system and breast disorders
Menorrhagia	1/311 (0.3%)
Vaginal haemorrhage	1/311 (0.3%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	8/311 (2.6%)
Epistaxis	3/311 (1%)
Pleural effusion	3/311 (1%)
Acute pulmonary oedema	1/311 (0.3%)
Chronic obstructive pulmonary disease	1/311 (0.3%)
Cough	1/311 (0.3%)
Haemothorax	1/311 (0.3%)
Pneumothorax	1/311 (0.3%)
Pulmonary embolism	1/311 (0.3%)
Respiratory failure	1/311 (0.3%)
Skin and subcutaneous tissue disorders
Angioedema	1/311 (0.3%)
Vascular disorders
Hypertension	5/311 (1.6%)
Deep vein thrombosis	2/311 (0.6%)
Thrombosis	2/311 (0.6%)
Intra-abdominal haemorrhage	1/311 (0.3%)
Peripheral vascular disorder	1/311 (0.3%)
Shock haemorrhagic	1/311 (0.3%)
Other (Not Including Serious) Adverse Events
	Sunitinib
	Affected / at Risk (%)	# Events
Total	299/311 (96.1%)
Blood and lymphatic system disorders
Anaemia	71/311 (22.8%)
Leukopenia	32/311 (10.3%)
Neutropenia	54/311 (17.4%)
Thrombocytopenia	48/311 (15.4%)
Endocrine disorders
Hypothyroidism	39/311 (12.5%)
Eye disorders
Periorbital oedema	23/311 (7.4%)
Gastrointestinal disorders
Abdominal discomfort	18/311 (5.8%)
Abdominal distension	29/311 (9.3%)
Abdominal pain	73/311 (23.5%)
Abdominal pain upper	41/311 (13.2%)
Constipation	66/311 (21.2%)
Diarrhoea	179/311 (57.6%)
Dry mouth	25/311 (8%)
Dyspepsia	56/311 (18%)
Flatulence	31/311 (10%)
Gastrooesophageal reflux disease	36/311 (11.6%)
Haemorrhoids	22/311 (7.1%)
Nausea	141/311 (45.3%)
Oral pain	34/311 (10.9%)
Stomatitis	45/311 (14.5%)
Vomiting	93/311 (29.9%)
General disorders
Asthenia	23/311 (7.4%)
Chest pain	29/311 (9.3%)
Chills	30/311 (9.6%)
Fatigue	206/311 (66.2%)
Mucosal inflammation	58/311 (18.6%)
Oedema	24/311 (7.7%)
Oedema peripheral	68/311 (21.9%)
Pain	25/311 (8%)
Pyrexia	60/311 (19.3%)
Infections and infestations
Sinusitis	18/311 (5.8%)
Upper respiratory tract infection	33/311 (10.6%)
Investigations
Aspartate aminotransferase increased	16/311 (5.1%)
Blood creatinine increased	20/311 (6.4%)
Haemoglobin decreased	20/311 (6.4%)
Weight decreased	28/311 (9%)
Metabolism and nutrition disorders
Decreased appetite	103/311 (33.1%)
Dehydration	25/311 (8%)
Hyperglycaemia	16/311 (5.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	55/311 (17.7%)
Back pain	65/311 (20.9%)
Muscle spasms	28/311 (9%)
Musculoskeletal pain	22/311 (7.1%)
Myalgia	23/311 (7.4%)
Pain in extremity	64/311 (20.6%)
Nervous system disorders
Dizziness	39/311 (12.5%)
Dysgeusia	48/311 (15.4%)
Headache	73/311 (23.5%)
Neuropathy peripheral	25/311 (8%)
Peripheral sensory neuropathy	16/311 (5.1%)
Psychiatric disorders
Anxiety	24/311 (7.7%)
Depression	21/311 (6.8%)
Insomnia	49/311 (15.8%)
Respiratory, thoracic and mediastinal disorders
Cough	73/311 (23.5%)
Dyspnoea	79/311 (25.4%)
Dyspnoea exertional	19/311 (6.1%)
Epistaxis	36/311 (11.6%)
Oropharyngeal pain	25/311 (8%)
Skin and subcutaneous tissue disorders
Dry skin	35/311 (11.3%)
Erythema	19/311 (6.1%)
Palmar-plantar erythrodysaesthesia syndrome	81/311 (26%)
Pruritus	19/311 (6.1%)
Rash	55/311 (17.7%)
Skin discolouration	58/311 (18.6%)
Skin discolouration	18/311 (5.8%)
Vascular disorders
Flushing	21/311 (6.8%)
Hypertension	54/311 (17.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.