Phase 2
Completed N=35
Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma
Carcinoma, Renal Cell
Source: ClinicalTrials.gov NCT00113529 ↗
Enrolled (actual)
35
Serious AEs
31.4%
Results posted
Mar 2010
Primary outcomePrimary: Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST) — 13 participants
Summary
To assess the maximum tolerated dose and overall safety and tolerability of sunitinib [SU011248] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST) |
13 | — |
| SECONDARY Time to Tumor Response (TTR) |
16.0 | — |
| SECONDARY Duration of Response (DR) |
52.2 | — |
| SECONDARY Time to Tumor Progression (TTP) |
48.4 | — |
| SECONDARY Overall Survival (OS) |
49.5 | — |
| SECONDARY Progression-Free Survival (PFS) |
48.4 | — |
| SECONDARY Probability of Survival at One Year |
82.4 | — |
| SECONDARY VEGF (Vascular Endothelial Growth Factor) Concentration at Baseline |
63.79 | — |
| SECONDARY VEGF Ratio to Baseline at Each Time Point |
2.29; 1.65; 2.65; 1.93; 2.26 | — |
| SECONDARY VEGF-C Concentration at Baseline |
725.82 | — |
| SECONDARY VEGF-C Ratio to Baseline at Each Time Point |
0.93; 0.86; 1.01; 1.09; 0.93 | — |
| SECONDARY Soluble VEGF Receptor 2 (sVEGFR2) Concentration at Baseline |
10525.0 | — |
| SECONDARY sVEGFR2 Ratio to Baseline at Each Time Point |
0.64; 0.82; 0.63; 0.75; 0.64 | — |
| SECONDARY Soluble VEGF Receptor 3 (sVEGFR3) Concentration at Baseline |
48355.48 | — |
| SECONDARY sVEGFR3 Ratio to Baseline at Each Time Point |
0.41; 0.96; 0.52; 0.89; 0.38 | — |
| SECONDARY Change From Baseline in VEGF by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) |
40.70; 94.50; 2.31; 1.94; 1.05; 1.01 | 0.075 |
| SECONDARY Change From Baseline in VEGFC by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) |
561.20; 751.30; 0.95; 0.71; 0.90; 0.80 | 0.473 |
| SECONDARY Change From Baseline in VEGFR2 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) |
10041.50; 9760.00; 0.59; 0.68; 0.79; 0.69 | 0.275 |
| SECONDARY Change From Baseline in VEGFR3 by Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] Versus PD) |
43325.00; 57300.00; 0.41; 0.34; 0.87; 0.71 | 0.435 |
| SECONDARY Change From Baseline in VEGF by Time Point Stratified by PFS >= Median and PFS < Median |
59.30; 44.70; 2.32; 2.28; 0.75; 1.06 | 0.734 |
| SECONDARY Change From Baseline in VEGFC by Time Point Stratified by PFS >= Median and PFS < Median |
650.80; 532.70; 0.76; 0.99; 0.80; 1.00 | 0.734 |
| SECONDARY Change From Baseline in VEGFR2 by Time Point Stratified by PFS >= Median and PFS < Median |
9100.00; 10145.00; 0.56; 0.69; 0.79; 0.78 | 0.910 |
| SECONDARY Change From Baseline in VEGFR3 by Time Point Stratified by PFS >= Median and PFS < Median |
55100.00; 47500.00; 0.29; 0.44; 0.86; 0.73 | 0.428 |
| SECONDARY Change From Baseline in VEGF by Time Point Stratified by TTP >= Median and TTP < Median |
59.30; 44.70; 2.32; 2.28; 0.75; 1.06 | 0.734 |
| SECONDARY Change From Baseline in VEGFC by Time Point Stratified by TTP >= Median and TTP < Median |
650.80; 532.70; 0.76; 0.99; 0.80; 1.00 | 0.734 |
| SECONDARY Change From Baseline in VEGFR2 by Time Point Stratified by TTP >= Median and TTP < Median |
9100.00; 10145.00; 0.56; 0.69; 0.79; 0.78 | 0.910 |
| SECONDARY Change From Baseline in VEGFR3 by Time Point Stratified by TTP >= Median and TTP < Median |
55100.00; 47500.00; 0.29; 0.44; 0.86; 0.73 | 0.428 |
| SECONDARY Trough Plasma Concentrations (Ctrough) of Sunitinib |
1.57; 33.16; 3.25; 35.50; 3.71; 35.97 | — |
| SECONDARY Ctrough of SU-012662 (Sunitinib's Metabolite) |
1.16; 16.21; 3.03; 15.25; 3.18; 14.56 | — |
| SECONDARY Ctrough of Gefitinib |
0.00; 254.74; 328.91; 263.23; 293.14; 211.43 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed renal cell carcinoma with metastases
- Evidence of unidimensionally measurable disease
- Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC
Exclusion Criteria
- RCC without any clear (conventional) cell component
- History of or known brain metastases
- Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry
Data sourced from ClinicalTrials.gov (NCT00113529). 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. Informational only — not medical advice.