A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00443534
• Collaborator: (none)
• Enrollment: 123
• Locations: 62
• Arm: 1
• Duration (Months): 67
• Patients Per Site: 2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms	Drug: SU011248	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 123 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: May 1, 2006
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: SU011248; Administered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior protocol; Other Names: Sutent/Sunitinib

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to Day 28 after last dose of study treatment]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Other Outcome Measures

1. Overall Survival (OS) [Baseline, every 2 months until death or up to 2 years after the last dose of study treatment]

   Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

2. Progression-Free Survival (PFS) [Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication]

   Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").

3. Time to Tumor Progression (TTP) [Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication]

   Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Participation in a previous SU011248 protocol and are judged by the investigator to have the potential to derive clinical benefit by remaining on SU011248 after the prior protocol ends.

Exclusion Criteria:

• Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Aurora	Colorado	United States	80045
2	Pfizer Investigational Site	Littleton	Colorado	United States	80120
3	Pfizer Investigational Site	Orlando	Florida	United States	32806
4	Pfizer Investigational Site	Atlanta	Georgia	United States	30322
5	Pfizer Investigational Site	Harvey	Illinois	United States	60426-4265
6	Pfizer Investigational Site	Harvey	Illinois	United States	60426
7	Pfizer Investigational Site	Maywood	Illinois	United States	60153
8	Pfizer Investigational Site	Tinley Park	Illinois	United States	60477
9	Pfizer Investigational Site	Zion	Illinois	United States	60099
10	Pfizer Investigational Site	Munster	Indiana	United States	46321
11	Pfizer Investigational Site	Baltimore	Maryland	United States	21201
12	Pfizer Investigational Site	Grand Rapids	Michigan	United States	49503
13	Pfizer Investigational Site	Creve Coeur	Missouri	United States	63141
14	Pfizer Investigational Site	St. Louis	Missouri	United States	63110
15	Pfizer Investigational Site	St. Peters	Missouri	United States	63376
16	Pfizer Investigational Site	Las Vegas	Nevada	United States	89135
17	Pfizer Investigational Site	Hackensack	New Jersey	United States	07601
18	Pfizer Investigational Site	Chapel Hill	North Carolina	United States	27599-7600
19	Pfizer Investigational Site	Clinton	North Carolina	United States	28328
20	Pfizer Investigational Site	Goldsboro	North Carolina	United States	27534
21	Pfizer Investigational Site	Hickory	North Carolina	United States	28602
22	Pfizer Investigational Site	Wilson	North Carolina	United States	27893
23	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73120
24	Pfizer Investigational Site	Tulsa	Oklahoma	United States	74104
25	Pfizer Investigational Site	Tulsa	Oklahoma	United States	74133
26	Pfizer Investigational Site	Tulsa	Oklahoma	United States	74136
27	Pfizer Investigational Site	Hershey	Pennsylvania	United States	17033
28	Pfizer Investigational Site	Greenville	South Carolina	United States	29615
29	Pfizer Investigational Site	Greer	South Carolina	United States	29650
30	Pfizer Investigational Site	Spartanburg	South Carolina	United States	29307
31	Pfizer Investigational Site	Bedford	Texas	United States	76022
32	Pfizer Investigational Site	Dallas	Texas	United States	75246
33	Pfizer Investigational Site	Fort Worth	Texas	United States	76177
34	Pfizer Investigational Site	Houston	Texas	United States	77030
35	Pfizer Investigational Site	San Antonio	Texas	United States	78207
36	Pfizer Investigational Site	San Antonio	Texas	United States	78217
37	Pfizer Investigational Site	San Antonio	Texas	United States	78229
38	Pfizer Investigational Site	San Antonio	Texas	United States	78258
39	Pfizer Investigational Site	Edmonton	Alberta	Canada	T6G 1Z2
40	Pfizer Investigational Site	Ottawa	Ontario	Canada	K1H 8L6
41	Pfizer Investigational Site	Montreal	Quebec	Canada	H2L 4M1
42	Pfizer Investigational Site	Montreal	Quebec	Canada	H3G 1A4
43	Pfizer Investigational Site	Montreal	Quebec	Canada	H3G 1L5
44	Pfizer Investigational Site	Lyon Cedex 08		France	69373
45	Pfizer Investigational Site	Marseille Cedex 20		France	13915
46	Pfizer Investigational Site	Villejuif		France	94805
47	Pfizer Investigational Site	Berlin		Germany	10117
48	Pfizer Investigational Site	Grosshansdorf		Germany	22927
49	Pfizer Investigational Site	Hamburg		Germany	20246
50	Pfizer Investigational Site	Wiesbaden		Germany	65199
51	Pfizer Investigational Site	Bologna		Italy	40138
52	Pfizer Investigational Site	Cremona		Italy	26100
53	Pfizer Investigational Site	Genova		Italy	16132
54	Pfizer Investigational Site	Milano		Italy	20133
55	Pfizer Investigational Site	Orbassano (TO)		Italy	10043
56	Pfizer Investigational Site	Rozzano (MI)		Italy	20089
57	Pfizer Investigational Site	Elche	Alicante	Spain	03203
58	Pfizer Investigational Site	Barcelona		Spain	08003
59	Pfizer Investigational Site	Cordoba		Spain	14004
60	Pfizer Investigational Site	Sutton	Surrey	United Kingdom	SM2 5PT
61	Pfizer Investigational Site	London		United Kingdom	SW3 6JJ
62	Pfizer Investigational Site	Manchester		United Kingdom	M20 4BX

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: NCT00443534
• Other Study ID Numbers: A6181078
• First Posted: Mar 6, 2007
• Last Update Posted: May 24, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Sunitinib

Study Results

Participant Flow

Recruitment Details	All participants were recruited from following previous sunitinib trials: NCT00798889, NCT00092001, NCT00137449, A6181049, A6181051, NCT00113516, NCT00265317, NCT00137423, NCT00267748, NCT00243503, NCT00471276, NCT00174434, NCT00528619, NCT00372775, NCT00417885, NCT00428597, and NCT00372567.

Arm/Group Title	Sunitinib
Arm/Group Description	Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
Period Title: Overall Study
STARTED	123
Treated	122
COMPLETED	0
NOT COMPLETED	123

Baseline Characteristics

Arm/Group Title	Sunitinib
Arm/Group Description	Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
Overall Participants	122
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.9 (11.7)
Sex: Female, Male (Count of Participants)
Female	61 50%
Male	61 50%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Baseline up to Day 28 after last dose of study treatment

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population included all enrolled participants who received at least 1 dose of study treatment.

Arm/Group Title	Sunitinib
Arm/Group Description	Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
Measure Participants	122
Adverse Events	119 97.5%
Serious Adverse Events	35 28.7%

2. Other Pre-specified Outcome

Title	Overall Survival (OS)
Description	Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time Frame	Baseline, every 2 months until death or up to 2 years after the last dose of study treatment

Outcome Measure Data

Analysis Population Description

Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.

Arm/Group Title	Sunitinib
Arm/Group Description	Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
Measure Participants	0

3. Other Pre-specified Outcome

Title	Progression-Free Survival (PFS)
Description	Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Time Frame	Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication

Outcome Measure Data

Analysis Population Description

Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.

Arm/Group Title	Sunitinib
Arm/Group Description	Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
Measure Participants	0

4. Other Pre-specified Outcome

Title	Time to Tumor Progression (TTP)
Description	Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
Time Frame	Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication

Outcome Measure Data

Analysis Population Description

Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.

Arm/Group Title	Sunitinib
Arm/Group Description	Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
Measure Participants	0

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	Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
All Cause Mortality
	Sunitinib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sunitinib
	Affected / at Risk (%)	# Events
Total	35/122 (28.7%)
Blood and lymphatic system disorders
Anaemia	3/122 (2.5%)
Febrile neutropenia	2/122 (1.6%)
Neutropenia	1/122 (0.8%)
Cardiac disorders
Congestive cardiomyopathy	1/122 (0.8%)
Endocrine disorders
Hypothyroidism	1/122 (0.8%)
Gastrointestinal disorders
Abdominal distension	1/122 (0.8%)
Abdominal pain	1/122 (0.8%)
Ascites	1/122 (0.8%)
Gastrointestinal haemorrhage	1/122 (0.8%)
Haematemesis	1/122 (0.8%)
Melaena	3/122 (2.5%)
Nausea	1/122 (0.8%)
Rectal haemorrhage	2/122 (1.6%)
Small intestinal obstruction	2/122 (1.6%)
Vomiting	2/122 (1.6%)
General disorders
Chest pain	1/122 (0.8%)
Condition aggravated	1/122 (0.8%)
Disease progression	9/122 (7.4%)
Gait disturbance	1/122 (0.8%)
Oedema peripheral	1/122 (0.8%)
Hepatobiliary disorders
Cholangitis	1/122 (0.8%)
Cholecystitis	2/122 (1.6%)
Infections and infestations
Appendicitis perforated	1/122 (0.8%)
Biliary sepsis	1/122 (0.8%)
Catheter site infection	1/122 (0.8%)
Gastroenteritis	2/122 (1.6%)
Pneumonia	1/122 (0.8%)
Urinary tract infection	1/122 (0.8%)
Injury, poisoning and procedural complications
Fall	2/122 (1.6%)
Metabolism and nutrition disorders
Dehydration	4/122 (3.3%)
Hypoglycaemia	1/122 (0.8%)
Musculoskeletal and connective tissue disorders
Back pain	3/122 (2.5%)
Pain in extremity	1/122 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer	1/122 (0.8%)
Nervous system disorders
Cerebral haemorrhage	1/122 (0.8%)
Headache	1/122 (0.8%)
Psychiatric disorders
Confusional state	1/122 (0.8%)
Renal and urinary disorders
Haematuria	1/122 (0.8%)
Renal failure	1/122 (0.8%)
Respiratory, thoracic and mediastinal disorders
Bronchiectasis	1/122 (0.8%)
Dyspnoea	3/122 (2.5%)
Pulmonary embolism	1/122 (0.8%)
Respiratory distress	1/122 (0.8%)
Vascular disorders
Hypertensive emergency	1/122 (0.8%)
Other (Not Including Serious) Adverse Events
	Sunitinib
	Affected / at Risk (%)	# Events
Total	115/122 (94.3%)
Blood and lymphatic system disorders
Anaemia	24/122 (19.7%)
Leukopenia	7/122 (5.7%)
Neutropenia	32/122 (26.2%)
Thrombocytopenia	17/122 (13.9%)
Eye disorders
Eyelid oedema	7/122 (5.7%)
Gastrointestinal disorders
Abdominal pain	13/122 (10.7%)
Abdominal pain upper	11/122 (9%)
Constipation	23/122 (18.9%)
Diarrhoea	49/122 (40.2%)
Dyspepsia	13/122 (10.7%)
Nausea	33/122 (27%)
Stomatitis	12/122 (9.8%)
Vomiting	22/122 (18%)
General disorders
Asthenia	13/122 (10.7%)
Chest pain	7/122 (5.7%)
Fatigue	36/122 (29.5%)
Mucosal inflammation	15/122 (12.3%)
Oedema peripheral	24/122 (19.7%)
Pain	8/122 (6.6%)
Pyrexia	15/122 (12.3%)
Infections and infestations
Nasopharyngitis	7/122 (5.7%)
Upper respiratory tract infection	9/122 (7.4%)
Investigations
Blood creatinine increased	8/122 (6.6%)
Weight decreased	10/122 (8.2%)
Metabolism and nutrition disorders
Decreased appetite	27/122 (22.1%)
Hypokalaemia	7/122 (5.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	8/122 (6.6%)
Back pain	18/122 (14.8%)
Pain in extremity	11/122 (9%)
Nervous system disorders
Dizziness	10/122 (8.2%)
Dysgeusia	12/122 (9.8%)
Headache	20/122 (16.4%)
Respiratory, thoracic and mediastinal disorders
Cough	13/122 (10.7%)
Dyspnoea	19/122 (15.6%)
Epistaxis	14/122 (11.5%)
Skin and subcutaneous tissue disorders
Dry skin	11/122 (9%)
Erythema	9/122 (7.4%)
Palmar-plantar erythrodysaesthesia syndrome	20/122 (16.4%)
Rash	9/122 (7.4%)
Vascular disorders
Hypertension	16/122 (13.1%)

Limitations/Caveats

The reason for not completed 'Study Terminated by Sponsor' in participant flow table indicates the termination of study at few sites as captured in case report forms at those sites and does not reflect overall status of study.

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.