Trials / Completed
CompletedNCT01396148
A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
A PHASE I/II STUDY OF SUNITINIB IN YOUNG PATIENTS WITH ADVANCED GASTROINTESTINAL STROMAL TUMOR
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 6 Years – 20 Years
- Healthy volunteers
- Not accepted
Summary
Children and young adults with gastrointestinal stromal tumors (GIST) will be treated with sunitinib. The safety (including pharmacokinetics) and tolerability of sunitinib will be studied in these patients. In addition, tumor responses and overall survival will be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | sunitinib malate dose escalation | sunitinib starting dose will be 15mg/m\^2 daily on a 4 weeks on/2 weeks off schedule (Schedule 4/2). |
| DRUG | sunitinib malate | sunitinib 50mg daily on Schedule 4/2 |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2017-08-01
- Completion
- 2017-08-01
- First posted
- 2011-07-18
- Last updated
- 2019-03-27
- Results posted
- 2018-03-12
Locations
9 sites across 3 countries: United States, Czechia, France
Source: ClinicalTrials.gov record NCT01396148. Inclusion in this directory is not an endorsement.