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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00716820
First received: July 15, 2008
Last updated: August 29, 2016
Last verified: August 2016
  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: Special Investigation For Gist Of Sutent (Regulatory Post Marketing Commitment Plan).

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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: 480
Study Start Date: May 2008
Study Completion Date: October 2015
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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: July 15, 2008
Results First Received: August 29, 2016
Last Updated: August 29, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 09, 2016