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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716820
First Posted: July 16, 2008
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention
Gastrointestinal Stromal Tumors Drug: SUNITINIB MALATE

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Outcome Survey Of Specific Use Of 12.5 Mg Sutent Capsule Against Gastrointestinal Stromal Tumor: Implementation Guidelines.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Treatment-Related Adverse Events [ Time Frame: MAX 2 Years ]
    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.).

  • Objective Response Rate [ Time Frame: MAX 2 Years ]
    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).


Secondary Outcome Measures:
  • Objective Response Rates by KIT Expression Status [ Time Frame: MAX 2 Years ]
    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.

  • Objective Response Rates by c-Kit Mutation Status [ Time Frame: MAX 2 Years ]
    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.

  • Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status [ Time Frame: MAX 2 Years ]
    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.

  • Number of Participants With Treatment-Related Adverse Events in Elderly Population [ Time Frame: MAX 2 Years ]
    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.

  • Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment [ Time Frame: MAX 2 Years ]
    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.

  • Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment [ Time Frame: MAX 2 Years ]
    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.

  • Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors [ Time Frame: MAX 2 Years ]
    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.

  • Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment [ Time Frame: MAX 2 Years ]
    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.

  • Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation [ Time Frame: MAX 2 Years ]
    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.).


Other Outcome Measures:
  • Number of Participants With Treatment-Related Serious Adverse Events [ Time Frame: MAX 2 Years ]
    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.).

  • Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [ Time Frame: MAX 2 Years ]
    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.).

  • Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE) [ Time Frame: MAX 2 Years ]
    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.


Enrollment: 472
Actual Study Start Date: April 2008
Study Completion Date: September 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SUNITINIB MALATE
Patients taking Sutent.
Drug: SUNITINIB MALATE

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."

Other Name: SUTENT

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients whom an investigator involving A6181175 prescribes the SUNITINIB MALATE(Sutent).
Criteria

Inclusion Criteria:

Patients need to be administered SUNITINIB MALATE(Sutent) in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not administered SUNITINIB MALATE(Sutent).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716820


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00716820     History of Changes
Other Study ID Numbers: A6181175
First Submitted: July 15, 2008
First Posted: July 16, 2008
Results First Submitted: August 29, 2016
Results First Posted: October 21, 2016
Last Update Posted: November 9, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors