Phase 2
N=36
A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)
Gastrointestinal Stromal Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00457743 ↗Enrolled (actual)
36
Serious AEs
41.7%
Results posted
Nov 2009
Primary outcome: Primary: Number of Subjects With Dose Limiting Toxicities (DLT) — 0; 0; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sunitinib malate (SU011248) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Dose Limiting Toxicities (DLT) |
0; 0; 2 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1 |
12.1; 22.8; 32.3; 1.96; 4.13; 4.81 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28 |
39.5; 69.3; 15.2; 38.8; 54.0; 105 | — |
| PRIMARY Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1 |
199; 374; 508; 30.9; 70.0; 91.1 | — |
| PRIMARY Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28 |
858; 1406; 324; 772; 1182; 2178 | — |
| PRIMARY Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1 |
6; 7; 8; 6; 9; 10 | — |
| PRIMARY Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28 |
10; 6; 4; 2.5; 6; 6 | — |
| PRIMARY SU-011248 Clearance on Cycle 1 Day 28 |
43.1; 38.1 | — |
| PRIMARY Accumulation Ratio (Rac) on Cycle 1 Day 28 |
3.32; 3.10; 4.31; 3.76; 7.98; 9.00 | — |
| PRIMARY Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group |
12; 0; 4; 8 | — |
| SECONDARY Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) |
55.30; 179.94; 192.42; 62.05; 173.12; 207.79 | — |
| SECONDARY Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2) |
8740.20; 5721.98; 5082.92; 7579.98; 5808.08; 4770.15 | — |
| SECONDARY Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT) |
48237.33; 53087.75; 35538.95; 39011.35; 40432.29; 30715.75 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) of SU-011248 |
58.93; 44.52; 1.17; 51.23; 48.09; 1.62 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) of SU-012262 |
26.41; 24.52; 2.01; 24.06; 24.47; 2.26 | — |
| SECONDARY Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 |
85.33; 69.05; 3.18; 75.29; 72.56; 3.88 | — |
| SECONDARY Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires |
1.0; -2.3; -6.3; -4.6; -0.4; 1.5 | — |
| SECONDARY Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires |
-0.148; -0.038; -0.121; -0.010; -0.091; -0.006 | — |
| SECONDARY Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group |
17; 0; 4; 13 | — |
| SECONDARY Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group |
4; 0; 4 | — |
| SECONDARY Time To Tumor Progression (TTP) |
30.3 | — |
| SECONDARY Progression-Free Survival (PFS) |
30.3 | — |
| SECONDARY Time To Failure (TTF) |
28.4 | — |
| SECONDARY Overall Survival Time |
62.0 | — |
Summary
Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability.
Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at the clinically recommended dose.
Eligibility Criteria
Inclusion Criteria
- Patients with histologically-confirmed metastatic or unresectable gastrointestinal stromal tumor (GIST).
- Patients previously treated with imatinib mesylate.
Exclusion Criteria
- Patients who have not recovered from the acute toxic effects of previous antineoplastic therapy or treatment with imatinib mesylate.
- Any tumor therapy for gastrointestinal stromal tumor (GIST) discontinued less than 4 weeks prior to starting study treatment. Imatinib mesylate discontinued less than 2 weeks prior to starting therapy.
Data sourced from ClinicalTrials.gov (NCT00457743). 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.