Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00836745
• Collaborator: (none)
• Enrollment: 36
• Locations: 7
• Duration (Months): 40
• Patients Per Site: 5.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The Sutent® Observational Study is being proposed to assess the real-world usage patterns and effectiveness and tolerability of treatment of Indian patients with advanced renal cell cancer with Sutent®. Generation of such information is expected to aid everyday clinical decision-making by Indian doctors and will add to the body of generalizable evidence.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Other: Non Interventional

Detailed Description

The assignment of the patient to Sutent® treatment is not decided in advance by this noninterventional study protocol, but falls within current practice. The decision to prescribe Sutent® is clearly not driven by the decision to include the patient in this study.The sample size for this study is not based on statistical considerations. It is expected that a minimum of 100 patients will be enrolled in the study by the end of the first year and the data collected would be adequate to fulfill the observational objectives of the study.The study will be initiated at 10 sites across India during the 1st year. The study may be expanded with the addition of new sites during the 2nd year.

Study Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Non-Interventional Study Of Indian Patients With Advanced Renal Cell Cancer Receiving Therapy With Sutent
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
1 Non Interventional	Other: Non Interventional; Sutent capsule, once daily administered per the locally approved product information.; Other Names: Observational

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival (PFS) [Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose)]

   PFS defined as the time (in weeks) from the date of first dose of sunitinib to the date of first documentation of objective tumor progression or death due to any cause, whichever occurs first. Date of first documentation of progression was based on radiological assessment of tumor measurements. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.

Secondary Outcome Measures

1. Percentage of Participants With Objective Response (OR) [Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose)]

   Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses were those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as the disappearance of all lesions (target and/or non- target). PR those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

2. Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events [Baseline up to 1 year from start of first dose]

   An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of skin and subcutaneous tissue related adverse events were presented.

3. Number of Participants Who Required Management of Other Adverse Events [Baseline up to 1 year from start of first dose]

   An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of other adverse events were to be presented.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with advanced renal cell cancer

• Treatment naïve or cytokine refractory

Exclusion Criteria:

• Patients presenting with a known hypersensitivity to Sunitinib or its metabolites

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Delhi	Delhi	India	110 085
2	Pfizer Investigational Site	Bangalore	Karnataka	India	560 027
3	Pfizer Investigational Site	Mumbai	Maharashtra	India	400014
4	Pfizer Investigational Site	Chandigard	Punjab	India	141402
5	Pfizer Investigational Site	Kolkata	West Bengal	India	700 106
6	Pfizer Investigational Site	Delhi		India	110 060
7	Pfizer Investigational Site	Jaipur		India	302006

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: NCT00836745
• Other Study ID Numbers: A6181181
• First Posted: Feb 4, 2009
• Last Update Posted: Dec 20, 2013
• Last Verified: Nov 1, 2013

• Keywords provided by Pfizer: Advanced renal cell Cancer; Non interventional study; Renal Cancer; Sutent; Metastatic; Advanced Renal Cell Carcinoma
• Additional relevant MeSH terms: Carcinoma, Renal Cell

Study Results

Participant Flow

Arm/Group Title	Sunitinib
Arm/Group Description	Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant's request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
Period Title: Overall Study
STARTED	36
COMPLETED	15
NOT COMPLETED	21

Baseline Characteristics

Arm/Group Title	Sunitinib
Arm/Group Description	Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant's request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
Overall Participants	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.8 (9.5)
Sex: Female, Male (Count of Participants)
Female	5 13.9%
Male	31 86.1%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS)
Description	PFS defined as the time (in weeks) from the date of first dose of sunitinib to the date of first documentation of objective tumor progression or death due to any cause, whichever occurs first. Date of first documentation of progression was based on radiological assessment of tumor measurements. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7.
Time Frame	Baseline until disease progression or death due to any cause or discontinuation from study treatment (up to 1 year from start of first dose)

Outcome Measure Data

Analysis Population Description

Data was not analyzed since PFS for all participants was censored either due to inadequate baseline assessments, absence of on-study disease assessment, or being on follow-up for progression.

Arm/Group Title	Sunitinib
Arm/Group Description	Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant's request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
Measure Participants	0

2. Secondary Outcome

Title	Percentage of Participants With Objective Response (OR)
Description	Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST). Confirmed responses were those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR defined as the disappearance of all lesions (target and/or non- target). PR those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time Frame	Baseline until disease progression or discontinuation from study treatment (up to 1 year from start of first dose)

Outcome Measure Data

Analysis Population Description

Per protocol (PP) analysis set included all enrolled participants who had the disease under study, measurable disease and an adequate baseline disease assessment, and who started sunitinib treatment.

Arm/Group Title	Sunitinib
Arm/Group Description	Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant's request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
Measure Participants	4
Number (95% Confidence Interval) [percentage of participants]	0 0%

3. Secondary Outcome

Title	Number of Participants Who Required Management of Skin and Subcutaneous Tissue Related Adverse Events
Description	An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of skin and subcutaneous tissue related adverse events were presented.
Time Frame	Baseline up to 1 year from start of first dose

Outcome Measure Data

Analysis Population Description

Safety analysis set included all enrolled participants who started treatment with sunitinib.

Arm/Group Title	Sunitinib
Arm/Group Description	Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant's request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
Measure Participants	36
Dose Reduction	1 2.8%
Dose Interruption	1 2.8%
Avoidance of Hot water for Cleaning Hands and Feet	1 2.8%

4. Secondary Outcome

Title	Number of Participants Who Required Management of Other Adverse Events
Description	An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants who required dose modifications and other measures for the management of other adverse events were to be presented.
Time Frame	Baseline up to 1 year from start of first dose

Outcome Measure Data

Analysis Population Description

Safety analysis set included all enrolled participants who started treatment with sunitinib.

Arm/Group Title	Sunitinib
Arm/Group Description	Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant's request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
Measure Participants	36
Number [participants]	20 55.6%

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 who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant's request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
All Cause Mortality
	Sunitinib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sunitinib
	Affected / at Risk (%)	# Events
Total	7/36 (19.4%)
Blood and lymphatic system disorders
Thrombocytopenia	1/36 (2.8%)
Cardiac disorders
Cardiopulmonary failure	1/36 (2.8%)
Myocardial ischaemia	1/36 (2.8%)
Gastrointestinal disorders
Constipation	1/36 (2.8%)
Melaena	1/36 (2.8%)
Stomatitis	1/36 (2.8%)
General disorders
Asthenia	1/36 (2.8%)
Disease progression	1/36 (2.8%)
Infections and infestations
Diabetic foot infection	1/36 (2.8%)
Injury, poisoning and procedural complications
Post procedural discharge	1/36 (2.8%)
Renal and urinary disorders
Haematuria	1/36 (2.8%)
Respiratory, thoracic and mediastinal disorders
Cough	1/36 (2.8%)
Pneumonitis	1/36 (2.8%)
Skin and subcutaneous tissue disorders
Diabetic foot	1/36 (2.8%)
Vascular disorders
Hypertension	1/36 (2.8%)
Other (Not Including Serious) Adverse Events
	Sunitinib
	Affected / at Risk (%)	# Events
Total	20/36 (55.6%)
Blood and lymphatic system disorders
Thrombocytopenia	1/36 (2.8%)
Endocrine disorders
Hypothyroidism	3/36 (8.3%)
Gastrointestinal disorders
Abdominal distension	1/36 (2.8%)
Abdominal pain	1/36 (2.8%)
Constipation	1/36 (2.8%)
Diarrhoea	2/36 (5.6%)
Gastritis	1/36 (2.8%)
Gastrooesophageal reflux disease	1/36 (2.8%)
Hiatus hernia	1/36 (2.8%)
Melaena	1/36 (2.8%)
Mouth ulceration	1/36 (2.8%)
Odynophagia	1/36 (2.8%)
Oral pain	1/36 (2.8%)
Stomatitis	2/36 (5.6%)
Toothache	1/36 (2.8%)
Vomiting	2/36 (5.6%)
General disorders
Adverse event	1/36 (2.8%)
Asthenia	3/36 (8.3%)
Chills	1/36 (2.8%)
Fatigue	1/36 (2.8%)
Mucosal inflammation	2/36 (5.6%)
Oedema	2/36 (5.6%)
Pyrexia	3/36 (8.3%)
Hepatobiliary disorders
Cholelithiasis	1/36 (2.8%)
Hepatic function abnormal	1/36 (2.8%)
Hyperbilirubinaemia	4/36 (11.1%)
Infections and infestations
Abdominal wall abscess	1/36 (2.8%)
Sinusitis	1/36 (2.8%)
Investigations
Alanine aminotransferase	2/36 (5.6%)
Alanine aminotransferase increased	1/36 (2.8%)
Aspartate aminotransferase	3/36 (8.3%)
Aspartate aminotransferase increased	1/36 (2.8%)
Blood alkaline phosphatase	2/36 (5.6%)
Blood creatinine	2/36 (5.6%)
Blood lactate dehydrogenase	1/36 (2.8%)
Neutrophil count	1/36 (2.8%)
Platelet count	1/36 (2.8%)
Weight decreased	4/36 (11.1%)
Weight increased	2/36 (5.6%)
Hyponatraemia	3/36 (8.3%)
Metabolism and nutrition disorders
Decreased appetite	4/36 (11.1%)
Hyperglycaemia	1/36 (2.8%)
Hypoalbuminaemia	1/36 (2.8%)
Hypocalcaemia	1/36 (2.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/36 (2.8%)
Back pain	3/36 (8.3%)
Mobility decreased	1/36 (2.8%)
Neck pain	1/36 (2.8%)
Pathological fracture	1/36 (2.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system	1/36 (2.8%)
Metastases to liver	1/36 (2.8%)
Nervous system disorders
Dizziness	1/36 (2.8%)
Headache	1/36 (2.8%)
Neuralgia	1/36 (2.8%)
Tremor	1/36 (2.8%)
Renal and urinary disorders
Bladder spasm	1/36 (2.8%)
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome	5/36 (13.9%)
Pruritus	1/36 (2.8%)
Rash	3/36 (8.3%)
Skin discolouration	1/36 (2.8%)
Skin hyperpigmentation	1/36 (2.8%)
Skin reaction	1/36 (2.8%)
Vascular disorders
Hypertension	1/36 (2.8%)

Limitations/Caveats

Relatively small sample size might limit any useful interpretation and applicability of data for larger populations.

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.