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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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

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)

Other Adverse Events

	Sunitinib Malate
Total, other (not including serious) adverse events
# participants affected / at risk	106
Blood and lymphatic system disorders
Anaemia ^†^A # participants affected / at risk	19/106 (17.92%)
Neutropenia ^† # participants affected / at risk	11/106 (10.38%)
Thrombocytopenia ^† # participants affected / at risk	11/106 (10.38%)
Endocrine disorders
Hypothyroidism ^† # participants affected / at risk	21/106 (19.81%)
Eye disorders
Lacrimation increased ^† # participants affected / at risk	7/106 (6.60%)
Gastrointestinal disorders
Abdominal discomfort ^† # participants affected / at risk	7/106 (6.60%)
Abdominal pain ^† # participants affected / at risk	19/106 (17.92%)
Abdominal pain upper ^† # participants affected / at risk	10/106 (9.43%)
Constipation ^† # participants affected / at risk	40/106 (37.74%)
Diarrhoea ^† # participants affected / at risk	67/106 (63.21%)
Dry mouth ^† # participants affected / at risk	10/106 (9.43%)
Dyspepsia ^† # participants affected / at risk	49/106 (46.23%)
Dysphagia ^† # participants affected / at risk	7/106 (6.60%)
Flatulence ^† # participants affected / at risk	11/106 (10.38%)
Gastrooesophageal reflux disease ^† # participants affected / at risk	12/106 (11.32%)
Glossodynia ^† # participants affected / at risk	11/106 (10.38%)
Haematochezia ^† # participants affected / at risk	6/106 (5.66%)
Haemorrhoids ^† # participants affected / at risk	9/106 (8.49%)
Nausea ^† # participants affected / at risk	66/106 (62.26%)
Oral pain ^† # participants affected / at risk	12/106 (11.32%)
Stomatitis ^† # participants affected / at risk	43/106 (40.57%)
Vomiting ^† # participants affected / at risk	51/106 (48.11%)
General disorders
Chest discomfort ^† # participants affected / at risk	7/106 (6.60%)
Chest pain ^† # participants affected / at risk	18/106 (16.98%)
Chills ^† # participants affected / at risk	20/106 (18.87%)
Fatigue ^† # participants affected / at risk	84/106 (79.25%)
Mucosal inflammation ^† # participants affected / at risk	28/106 (26.42%)
Oedema ^† # participants affected / at risk	10/106 (9.43%)
Oedema peripheral ^† # participants affected / at risk	22/106 (20.75%)
Pain ^† # participants affected / at risk	13/106 (12.26%)
Pyrexia ^† # participants affected / at risk	19/106 (17.92%)
Infections and infestations
Nasopharyngitis ^† # participants affected / at risk	10/106 (9.43%)
Sinusitis ^† # participants affected / at risk	9/106 (8.49%)
Upper respiratory tract infection ^† # participants affected / at risk	22/106 (20.75%)
Urinary tract infection ^† # participants affected / at risk	9/106 (8.49%)
Investigations
Aspartate aminotransferase increased ^† # participants affected / at risk	6/106 (5.66%)
Blood creatinine increased ^† # participants affected / at risk	9/106 (8.49%)
Ejection fraction decreased ^† # participants affected / at risk	19/106 (17.92%)
Haemoglobin decreased ^† # participants affected / at risk	8/106 (7.55%)
Lipase increased ^† # participants affected / at risk	12/106 (11.32%)
Neutrophil count decreased ^† # participants affected / at risk	11/106 (10.38%)
Platelet count decreased ^† # participants affected / at risk	16/106 (15.09%)
Weight decreased ^† # participants affected / at risk	18/106 (16.98%)
Weight increased ^† # participants affected / at risk	7/106 (6.60%)
White blood cell count decreased ^† # participants affected / at risk	12/106 (11.32%)
Metabolism and nutrition disorders
Anorexia ^† # participants affected / at risk	43/106 (40.57%)
Dehydration ^† # participants affected / at risk	11/106 (10.38%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† # participants affected / at risk	24/106 (22.64%)
Back pain ^† # participants affected / at risk	27/106 (25.47%)
Bone pain ^† # participants affected / at risk	13/106 (12.26%)
Flank pain ^† # participants affected / at risk	9/106 (8.49%)
Muscle spasms ^† # participants affected / at risk	10/106 (9.43%)
Muscular weakness ^† # participants affected / at risk	8/106 (7.55%)
Musculoskeletal chest pain ^† # participants affected / at risk	12/106 (11.32%)
Musculoskeletal pain ^† # participants affected / at risk	14/106 (13.21%)
Myalgia ^† # participants affected / at risk	21/106 (19.81%)
Pain in extremity ^† # participants affected / at risk	37/106 (34.91%)
Nervous system disorders
Dizziness ^† # participants affected / at risk	19/106 (17.92%)
Dysgeusia ^† # participants affected / at risk	54/106 (50.94%)
Headache ^† # participants affected / at risk	32/106 (30.19%)
Hypoaesthesia ^† # participants affected / at risk	7/106 (6.60%)
Paraesthesia ^† # participants affected / at risk	10/106 (9.43%)
Peripheral sensory neuropathy ^† # participants affected / at risk	6/106 (5.66%)
Psychiatric disorders
Anxiety ^† # participants affected / at risk	10/106 (9.43%)
Depression ^† # participants affected / at risk	12/106 (11.32%)
Insomnia ^† # participants affected / at risk	14/106 (13.21%)
Renal and urinary disorders
Dysuria ^† # participants affected / at risk	10/106 (9.43%)
Respiratory, thoracic and mediastinal disorders
Cough ^† # participants affected / at risk	26/106 (24.53%)
Dysphonia ^† # participants affected / at risk	7/106 (6.60%)
Dyspnoea ^† # participants affected / at risk	27/106 (25.47%)
Dyspnoea exertional ^† # participants affected / at risk	12/106 (11.32%)
Epistaxis ^† # participants affected / at risk	25/106 (23.58%)
Haemoptysis ^† # participants affected / at risk	9/106 (8.49%)
Nasal congestion ^† # participants affected / at risk	7/106 (6.60%)
Oropharyngeal pain ^† # participants affected / at risk	11/106 (10.38%)
Productive cough ^† # participants affected / at risk	8/106 (7.55%)
Skin and subcutaneous tissue disorders
Alopecia ^† # participants affected / at risk	14/106 (13.21%)
Blister ^† # participants affected / at risk	10/106 (9.43%)
Dry skin ^† # participants affected / at risk	23/106 (21.70%)
Erythema ^† # participants affected / at risk	15/106 (14.15%)
Hair colour changes ^† # participants affected / at risk	21/106 (19.81%)
Hyperhidrosis ^† # participants affected / at risk	6/106 (5.66%)
Palmar—plantar erythrodysaesthesia syndrome ^† # participants affected / at risk	30/106 (28.30%)
Periorbital oedema ^† # participants affected / at risk	12/106 (11.32%)
Pruritus ^† # participants affected / at risk	8/106 (7.55%)
Rash ^† # participants affected / at risk	38/106 (35.85%)
Skin discolouration ^† # participants affected / at risk	35/106 (33.02%)
Skin exfoliation ^† # participants affected / at risk	12/106 (11.32%)
Skin lesion ^† # participants affected / at risk	10/106 (9.43%)
Skin reaction ^† # participants affected / at risk	8/106 (7.55%)
Vascular disorders
Hot flush ^† # participants affected / at risk	7/106 (6.60%)
Hypertension ^† # participants affected / at risk	38/106 (35.85%)

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

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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