Phase 2
Completed N=66
Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases
Source: ClinicalTrials.gov NCT00372775 ↗Enrolled (actual)
66
Serious AEs
53.1%
Results posted
Feb 2011
Primary outcomePrimary: Progression-Free Survival (PFS) — 9.4 Weeks
Summary
This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
9.4 | — |
| SECONDARY Time to Tumor Progression (TTP) |
15.1 | — |
| SECONDARY Time to Neurological Progression (TNP) |
8.1 | — |
| SECONDARY Number of Participants With Objective Disease Response |
1 | — |
| SECONDARY Time to Objective Intracranial Progression |
15.4 | — |
| SECONDARY Number of Participants With Intracranial Objective Disease Response |
1 | — |
| SECONDARY Duration of Response (DR) |
32.1; 8.26 | — |
| SECONDARY Overall Survival (OS) |
5.8 | — |
| SECONDARY Percentage of Participants Surviving at 1 Year |
23.4 | — |
| SECONDARY Number of Deaths Due to Intracranial Versus Systemic Progression |
48; 0 | — |
| SECONDARY Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score |
17.62; 0.52; 1.11; -0.48; 0.64; -0.63 | — |
| SECONDARY Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score |
45.72; -1.25; -0.58; 0.66; -1.87; -1.92 | — |
| SECONDARY Trough Plasma Concentrations (Ctrough) of Sunitinib |
50.89; 46.27; 51.10 | — |
| SECONDARY Ctrough of Sunitinib Metabolite (SU012662) |
33.85; 28.45; 28.91 | — |
| SECONDARY Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms With Blood Counts |
— | — |
| SECONDARY Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile |
— | — |
| SECONDARY PFS in Subgroups Defined by RNA Expression Profiles of Tumors |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients with radiologically proven brain metastases secondary to non-small cell lung cancer
- Received previous whole brain radiation therapy and none, 1 or 2 prior systemic therapy for the treatment of advanced/metastatic non-small cell lung cancer
Exclusion Criteria
- Patients with brainstem lesions, spinal cord compression. carcinomatous meningitis, or leptomeningeal disease.
- Brain metastases >4 cm in any linear direction
- Intracranial or intratumoral hemorrhage
Data sourced from ClinicalTrials.gov (NCT00372775). 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.