Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Sunitinib

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Non-small cell lung cancer, carcinoma, sunitinib, Phase 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed advanced or metastatic Non-Small Cell Lung Cancer that cannot be cured with surgery, radiation, or combination thereof No more than 2 prior chemotherapy treatments including treatment with a platinum containing therapy Evidence of measurable disease by radiographic technique Male or Female, 18 years or older ECOG performance status of 0 or 1 Resolution of all acute toxicities of prior therapies Adequate organ function Exclusion Criteria: Major surgery or radiation therapy within 4 weeks Severe hemorrhage within 4 weeks Previous treatment with anti-angiogenesis agents Diagnosis of second malignancy within last five 5 years History of or known brain metastases, spinal cord compression, or carcinomatous meningitis Known HIV Serious acute or chronic illness Current treatment on another clinical trial Pregnant or breastfeeding

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Overall confirmed objective response rate (ORR)

Secondary Outcome Measures

Progression-free survival (PFS)

Time to progression (TTP)

Duration of response (DR)

Overall survival (OS)

Probability of survival at 1 year

Full Information

NCT ID

NCT00092001

First Posted

September 21, 2004

Last Updated

October 15, 2008

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00092001

Brief Title

Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

Official Title

A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study is to test whether SU011248 has activity and is safe in patients with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing regimen and docetaxel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

Keywords

Non-small cell lung cancer, carcinoma, sunitinib, Phase 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

111 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Sunitinib

Other Intervention Name(s)

Sutent, SU011248

Intervention Description

Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.

Primary Outcome Measure Information:

Title

Overall confirmed objective response rate (ORR)

Time Frame

From screening until at least 28 days beyond discontinuation of study treatment.

Secondary Outcome Measure Information:

Title

Progression-free survival (PFS)

Time Frame