Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00372775
• Date of registration: 05/09/2006
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases
• Scientific title: A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastases
• Date of first enrolment: March 2007
• Target sample size: 66
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00372775
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

France, Italy, Spain, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-Small Cell Lung Cancer

Intervention(s)

Drug: Sunitinib

Primary Outcome(s)

Progression-Free Survival (PFS) [Time Frame: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)]

Secondary Outcome(s)

Percentage of Participants Surviving at 1 Year [Time Frame: Year 1]

Trough Plasma Concentrations (Ctrough) of Sunitinib [Time Frame: Day 1 of Week 5, 9, and 13]

Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score [Time Frame: Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)]

Overall Survival (OS) [Time Frame: Baseline until death (up to 1 year)]

Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms With Blood Counts [Time Frame: Day 1 prior to dosing]

Ctrough of Sunitinib Metabolite (SU012662) [Time Frame: Day 1 of Week 5, 9, and 13]

Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score [Time Frame: Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)]

Duration of Response (DR) [Time Frame: Day 7 of Week 4 and every 4 weeks up to 1 year]

Number of Participants With Objective Disease Response [Time Frame: Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49]

PFS in Subgroups Defined by RNA Expression Profiles of Tumors [Time Frame: Day 1 of Week 1 and every 4 weeks up to 1 year]

Number of Participants With Intracranial Objective Disease Response [Time Frame: Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49]

Time to Tumor Progression (TTP) [Time Frame: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression (up to 1 year)]

Number of Deaths Due to Intracranial Versus Systemic Progression [Time Frame: Baseline until death (up to 1 year)]

Time to Objective Intracranial Progression [Time Frame: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to intracranial tumor progression (up to 1 year)]

Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile [Time Frame: Day 1 of Week 1 and every 4 weeks up to 1 year]

Time to Neurological Progression (TNP) [Time Frame: Baseline, Day 28 to focal neurological deficit (up to 1 year)]

Secondary ID(s)

A6181092

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/02/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00372775