A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma. - Study Results

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Condition:	Carcinoma, Renal Cell
Intervention:	Drug: SU011248

	Sunitinib Malate
STARTED	106
COMPLETED	2
NOT COMPLETED	104
Adverse Event	22
Protocol Violation	1
Withdrawal by Subject	3
Lack of Efficacy	76
Decision of Sponsor	2

	Sunitinib Malate
Number of Participants [units: participants]	106
Age, Customized [units: participants]
< 65 years	87
>= 65 years	19
Gender [units: participants]
Female	39
Male	67

Outcome Measures

1. Primary:

Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST) [ From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter ]

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2. Secondary:

Time to Tumor Progression (TTP) [ From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter ]

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3. Secondary:

Duration of Response (DR) [ Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer ]

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4. Secondary:

Overall Survival (OS) [ From start of study treatment until death ]

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5. Secondary:

Progression-free Survival (PFS) [ From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death ]

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6. Secondary:

Percent Chance of Patient Survival [ From start of study treatment until death ]

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7. Secondary:

Observed Plasma Trough Concentrations of Sunitinib [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

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8. Secondary:

Observed Plasma Trough Concentrations of Sunitinib Metabolite [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

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9. Secondary:

Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

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10. Secondary:

Dose Corrected Plasma Trough Concentrations of Sunitinib [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

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11. Secondary:

Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

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12. Secondary:

Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite [ Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater ]

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Serious Adverse Events

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Reporting Groups

	Description
Sunitinib Malate	50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)

Serious Adverse Events

	Sunitinib Malate
Total, serious adverse events
# participants affected / at risk	46/106 (43.40%)
Blood and lymphatic system disorders
Anaemia ^†^A # participants affected / at risk	2/106 (1.89%)
Thrombocytopenia ^† # participants affected / at risk	1/106 (0.94%)
Cardiac disorders
Acute myocardial infarction ^† # participants affected / at risk	2/106 (1.89%)
Cardiac failure congestive ^† # participants affected / at risk	1/106 (0.94%)
Myocardial infarction ^† # participants affected / at risk	2/106 (1.89%)
Myocardial ischaemia ^† # participants affected / at risk	1/106 (0.94%)
Endocrine disorders
Adrenocortical insufficiency acute ^† # participants affected / at risk	1/106 (0.94%)
Gastrointestinal disorders
Abdominal pain ^† # participants affected / at risk	1/106 (0.94%)
Diarrhoea ^† # participants affected / at risk	1/106 (0.94%)
Intestinal obstruction ^† # participants affected / at risk	1/106 (0.94%)
Nausea ^† # participants affected / at risk	1/106 (0.94%)
Pancreatitis ^† # participants affected / at risk	1/106 (0.94%)
Rectal haemorrhage ^† # participants affected / at risk	1/106 (0.94%)
Stomatitis ^† # participants affected / at risk	1/106 (0.94%)
Vomiting ^† # participants affected / at risk	2/106 (1.89%)
General disorders
Disease progression ^† # participants affected / at risk	7/106 (6.60%)
Fatigue ^† # participants affected / at risk	1/106 (0.94%)
Impaired healing ^† # participants affected / at risk	1/106 (0.94%)
Non—cardiac chest pain ^† # participants affected / at risk	2/106 (1.89%)
Oedema peripheral ^† # participants affected / at risk	1/106 (0.94%)
Hepatobiliary disorders
Portal vein thrombosis ^† # participants affected / at risk	1/106 (0.94%)
Infections and infestations
Abscess ^† # participants affected / at risk	1/106 (0.94%)
Anorectal infection ^† # participants affected / at risk	1/106 (0.94%)
Clostridium difficile colitis ^† # participants affected / at risk	1/106 (0.94%)
Gastroenteritis viral ^† # participants affected / at risk	1/106 (0.94%)
Infection ^† # participants affected / at risk	2/106 (1.89%)
Pancreatic abscess ^† # participants affected / at risk	1/106 (0.94%)
Perirectal abscess ^† # participants affected / at risk	1/106 (0.94%)
Pneumonia ^† # participants affected / at risk	3/106 (2.83%)
Sepsis ^† # participants affected / at risk	1/106 (0.94%)
Staphylococcal infection ^† # participants affected / at risk	1/106 (0.94%)
Urinary tract infection ^† # participants affected / at risk	1/106 (0.94%)
Injury, poisoning and procedural complications
Femur fracture ^† # participants affected / at risk	1/106 (0.94%)
Skeletal injury ^† # participants affected / at risk	1/106 (0.94%)
Investigations
Ejection fraction decreased ^† # participants affected / at risk	1/106 (0.94%)
International normalised ratio increased ^† # participants affected / at risk	1/106 (0.94%)
Oxygen saturation decreased ^† # participants affected / at risk	1/106 (0.94%)
Platelet count decreased ^† # participants affected / at risk	1/106 (0.94%)
Metabolism and nutrition disorders
Dehydration ^† # participants affected / at risk	5/106 (4.72%)
Failure to thrive ^† # participants affected / at risk	1/106 (0.94%)
Hypercalcaemia ^† # participants affected / at risk	1/106 (0.94%)
Hyperglycaemia ^† # participants affected / at risk	1/106 (0.94%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† # participants affected / at risk	2/106 (1.89%)
Musculoskeletal pain ^† # participants affected / at risk	1/106 (0.94%)
Osteonecrosis ^† # participants affected / at risk	2/106 (1.89%)
Nervous system disorders
Convulsion ^† # participants affected / at risk	1/106 (0.94%)
Hypoglycaemic encephalopathy ^† # participants affected / at risk	1/106 (0.94%)
Reversible posterior leukoencephalopathy syndrome ^† # participants affected / at risk	1/106 (0.94%)
Speech disorder ^† # participants affected / at risk	1/106 (0.94%)
Spinal cord compression ^† # participants affected / at risk	2/106 (1.89%)
Syncope ^† # participants affected / at risk	1/106 (0.94%)
Psychiatric disorders
Depression ^† # participants affected / at risk	1/106 (0.94%)
Mental status changes ^† # participants affected / at risk	2/106 (1.89%)
Renal and urinary disorders
Renal failure ^† # participants affected / at risk	3/106 (2.83%)
Renal failure acute ^† # participants affected / at risk	2/106 (1.89%)
Ureteric obstruction ^† # participants affected / at risk	1/106 (0.94%)
Reproductive system and breast disorders
Uterine haemorrhage ^† # participants affected / at risk	1/106 (0.94%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† # participants affected / at risk	2/106 (1.89%)
Pleural effusion ^† # participants affected / at risk	2/106 (1.89%)
Pneumothorax ^† # participants affected / at risk	1/106 (0.94%)
Pulmonary embolism ^† # participants affected / at risk	1/106 (0.94%)
Skin and subcutaneous tissue disorders
Petechiae ^† # participants affected / at risk	1/106 (0.94%)
Purpura ^† # participants affected / at risk	1/106 (0.94%)
Surgical and medical procedures
Fracture treatment ^† # participants affected / at risk	1/106 (0.94%)
Tumour excision ^† # participants affected / at risk	1/106 (0.94%)
Vascular disorders
Aortic stenosis ^† # participants affected / at risk	1/106 (0.94%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA (11.0)

Other Adverse Events

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More Information

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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.

The agreement is:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided by Pfizer

Publications automatically indexed to this study:

Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24.

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181006
Study First Received:	February 13, 2004
Results First Received:	September 25, 2009
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00077974 History of Changes
Health Authority:	United States: Food and Drug Administration