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Sutent

Phase 2

Non Small Cell Lung Cancer | Small molecule | Oncology |McKesson Corporation|Last Updated: Oct 16, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment63

FDA Designations

No designations recorded

Clinical trial landscape

Sutent · 1 trial · 1 indication

Phase 2 1
NCT00864721Sunitinib Non Small Cell Lung Cancer Patients Over 70Non Small Cell Lung Cancer
COMPLETED63 Analytics
PHASE2COMPLETED
Sunitinib Non Small Cell Lung Cancer Patients Over 70
Non Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Disease Control Rate (DCR)
Every 6 weeks until progressive disease or death due to any cause, up to 36 month.

Disease control rate = CR + PR + SD\>=6-weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Stable Disease (SD) is defined as persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.

Secondary Endpoints

Overall Response Rates (OR)
Every 6 weeks until progressive disease or death due to any causes, up to 36 months.
Progression-free Survival (PFS)
All patients were followed until progressive disease or death, up to 36 months.
1-year Overall Survival (OS) Rate.
All patients were followed until death or up to 36 months.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sunitinib MalateEXPERIMENTALSunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.

Interventions

NameTypeDescription
SutentDRUGSunitinib malate (Sutent) will be taken on an outpatient basis. Sunitinib malate (Sutent) should be taken at the dose of 37.5 mg/day by mouth; drug will only be taken Days 1-42 of each 42-day cycle.
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Eligibility Criteria

Age Range70 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Has measurable, metastatic NSCLC, other elderly NSCLC patients over 70 years of age who are not felt to be candidates for standard chemotherapy at the discretion of the treating physician may also be enrolled as long as they meet the criteria; these "special consideration" pat...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Non Small Cell Lung Cancer")

Frequently asked questions about Sutent

What is Sutent used for in Non Small Cell Lung Cancer?

Sutent is being studied for use in Non Small Cell Lung Cancer, specifically in patients over 70 years old. It is an investigational small molecule oncology drug currently in Phase 2 clinical development. The completed clinical trial enrolled 63 participants in the United States.

Who makes Sutent?

Sutent is developed by McKesson Corporation, which trades under the ticker symbol MCK. The company is conducting clinical research on this small molecule for the treatment of Non Small Cell Lung Cancer.

What phase is Sutent in?

Sutent is in Phase 2 clinical development for Non Small Cell Lung Cancer. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, with no active trials currently ongoing.

What clinical trials is Sutent in?

Sutent has one completed clinical trial registered as NCT00864721, titled 'Sunitinib Non Small Cell Lung Cancer Patients Over 70'. This Phase 2 study enrolled 63 patients with Non Small Cell Lung Cancer in the United States, with a minimum age of 70 years.

Is Sutent FDA approved?

Sutent is not FDA approved for Non Small Cell Lung Cancer. It is an investigational drug currently in Phase 2 clinical development. The completed trial NCT00864721 was uncontrolled and not randomized or double-blinded, indicating early-stage research.

How does Sutent work?

Sutent is a small molecule drug being studied for Non Small Cell Lung Cancer. The specific molecular target has not been disclosed in the available clinical trial information. It is being evaluated in a biomarker-selected patient population.