Phase 2
N=6
A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor
Gastrointestinal Stromal Tumors
Bottom Line
View on ClinicalTrials.gov: NCT01396148 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Estimated Steady-State Maximum Plasma Concentration (Cmax,ss) of Sunitinib and Its Metabolite — 37.98; 14.55 nanograms per milliliter (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sunitinib malate dose escalation (Drug); sunitinib malate (Drug)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Steady-State Maximum Plasma Concentration (Cmax,ss) of Sunitinib and Its Metabolite |
37.98; 14.55 | — |
| PRIMARY Estimated Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose AUC(0-24) of Sunitinib and Its Metabolite |
812.59; 336.78 | — |
| PRIMARY Estimated Oral Clearance (CL/F) of Sunitinib and Its Metabolite |
26.37; 12.85 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Sunitinib and Its Metabolite |
17.58; 2.342 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) for Sunitinib and Its Metabolite |
8; 8 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours Post Dose AUC(0-8) for Sunitinib and Its Metabolite |
77.49; 10.11 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
6; 0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0 |
5 | — |
| SECONDARY Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
6; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities |
— | — |
| SECONDARY Number of Participants With Objective Response |
0; 0 | — |
| SECONDARY Duration of Response |
— | — |
| SECONDARY Progression-Free Survival |
5.8 | — |
| SECONDARY Overall Survival |
NA | — |
| SECONDARY Number of Participants With Adverse Events Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) for Pharmacokinetic (PK) Subgroups |
0; 2; 0; 1; 0; 2 | — |
| SECONDARY Pearson Correlation Coefficient Between Percent Change From Baseline in Laboratory Parameters With Total Drug (Sunitinib + SU012662) Concentration |
-0.1870; -0.5914; -0.5536; 0.0329; -0.6424; -0.6604 | — |
| SECONDARY Pearson Correlation Coefficient Between Percent Change From Baseline in Vital Sign Results With Total Drug (Sunitinib + SU012662) Concentration |
-0.3730; -0.8146; 0.2768; 0.6854; -0.3638; 0.2634 | — |
| SECONDARY Number of Participants With Stable Disease (SD), Partial Response (PR), Complete Response (CR) and Progressive Disease (PD) for PK Sub-groups |
1; 2; 0; 0; 0; 0 | — |
| SECONDARY Progression Free Survival for PK Subgroups |
2.6; 9.0 | — |
| SECONDARY Pearson Correlation Coefficient Between Progression Free Survival With Total Drug (Sunitinib + SU012662) Concentration |
0.5904 | — |
| SECONDARY Estimated Sunitinib Plasma Concentration at Which 50% of the Maximum Effect (EC50) for Each Selected Efficacy Parameter (e.g., Sum of Largest Diameters for Target Tumors) Was Observed |
— | — |
| SECONDARY Estimated Sunitinib Plasma Concentration at Which 50% of the Maximum Effect (EC50) for Each Selected Safety Endpoint (e.g., Absolute Neutrophil Count) Was Observed |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Histological diagnosis of GIST.
- Patients must have demonstrated either disease progression or intolerance to imatinib mesylate, have non-mutant Stem Cell Factor Receptor gene (KIT) GIST, or cannot obtain imatinib in their country
- Measurable by Response Evaluation Criterion in Solid Tumors (RECIST) or evaluable disease.
Exclusion Criteria
- Current treatment with another investigational agent.
- Prior sunitinib treatment.
- Prior therapy with known risk for cardiovascular complications.
Data sourced from ClinicalTrials.gov (NCT01396148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.