Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

SUTENT capsule 12.5 mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral sunitinib is 50 mg once daily, 4 weeks on followed by 2 weeks off (Schedule 4/2). This comprises 1 treatment cycle, which may be repeated.

The dosage may be decreased according to the patient's clinical condition."

SUNITINIB MALATE

Pfizer CT.gov Call Center

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first SUNITINIB MALATE(Sutent) should be registered.

Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).

Outcome Survey Of Specific Use Of 12.5 Mg Sutent Capsule Against Gastrointestinal Stromal Tumor: Implementation Guidelines.

A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).

A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).

A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.

A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).

Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by KIT expression status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.

Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by c-kit mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.

Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by PDGFRα mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.

A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.

A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.

A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.

A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.

A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.

The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).

Pfizer

The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. 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.

Usually, 50 mg of sunitinib malate was orally administered to adult participants once daily in repetitive cycles of 4 weeks on treatment followed by 2 weeks off according to Japanese package insert.

Sunitinib Malate

<15 years

>=15 and <65 years

˃=65 years

Unknown

Age, Customized

Sex: Female, Male

Pfizer ClinicalTrials.gov Call Center

Safety analysis set comprised of participants who had met the inclusion criteria and had received sunitinib malate at least once.

Number of Participants With Treatment-Related Adverse Events

Efficacy analysis set comprised of participants in safety analysis set who had efficacy evaluation.

Objective Response Rate

Participants with positive KIT expression who received sunitinib malate according to Japanese package insert

KIT Positive

Participants with negative KIT expression who received sunitinib malate according to Japanese package insert

KIT Negative

Participants with unknown KIT expression status who received sunitinib malate according to Japanese package insert

Objective Response Rates by KIT Expression Status

Participants with c-kit mutation who received sunitinib malate according to Japanese package insert

c-Kit With Mutation

Participants without c-kit mutation who received sunitinib malate according to Japanese package insert

c-Kit Without Mutation

Participants with unknown c-kit mutation status who received sunitinib malate according to Japanese package insert

Objective Response Rates by c-Kit Mutation Status

Participants with PDGFRα mutation who received sunitinib malate according to Japanese package insert

PDGFRα With Mutation

Participants without PDGFRα mutation who received sunitinib malate according to Japanese package insert

PDGFRα Without Mutation

Participants with unknown PDGFRα mutation status who received sunitinib malate according to Japanese package insert

Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status

Participants aged ˃=65 years who received sunitinib malate according to Japanese package insert

Elderly

Participants aged ˂65 years who received sunitinib malate according to Japanese package insert

Non-elderly

Participants with unknown age who received sunitinib malate according to Japanese package insert

Number of Participants With Treatment-Related Adverse Events in Elderly Population

Participants with baseline hepatic impairment who received sunitinib malate according to Japanese package insert

With Hepatic Impairment

Participants without baseline hepatic impairment who received sunitinib malate according to Japanese package insert

Without Hepatic Impairment

Participants with no information on baseline hepatic impairment who received sunitinib malate according to Japanese package insert

Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment

Participants with baseline renal impairment who received sunitinib malate according to Japanese package insert

With Renal Impairment

Participants without baseline renal impairment who received sunitinib malate according to Japanese package insert

Without Renal Impairment

Participants with no information on baseline renal impairment who received sunitinib malate according to Japanese package insert

Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment

Participants with concomitant CYP3A4 inhibitors at start of sunitinib malate treatment according to Japanese package insert

With Concomitant CYP3A4 Inhibitors (Start of Treatment)

Participants with concomitant CYP3A4 inhibitors during sunitinib malate treatment according to Japanese package insert

With Concomitant CYP3A4 Inhibitors (During Treatment)

Participants without concomitant CYP3A4 inhibitors on sunitinib malate treatment according to Japanese package insert

Spots Global Cancer Trial Database for Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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