Trials / Completed
CompletedNCT00716820
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.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 472 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
All the patients whom an investigator prescribes the first SUNITINIB MALATE(Sutent) should be registered.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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." |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2015-10-01
- Completion
- 2016-09-01
- First posted
- 2008-07-16
- Last updated
- 2023-04-06
- Results posted
- 2016-10-21
Source: ClinicalTrials.gov record NCT00716820. Inclusion in this directory is not an endorsement.