NCT00712504

Brief Summary

This study is determining the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel (Taxotere). Several dosing regimens will be tested in patients with advanced solid tumors, including non small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2004

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2008

Completed
Last Updated

November 11, 2008

Status Verified

November 1, 2008

Enrollment Period

3.3 years

First QC Date

July 7, 2008

Last Update Submit

November 7, 2008

Conditions

Advanced Solid TumorsNon Small Cell Lung Cancer

Keywords

advanced solid tumors, non small cell lung cancer, pulmonary neoplasms, sunitinib (SUTENT), docetaxel (Taxotere), Angiogenesis Inhibitors

Outcome Measures

Primary Outcomes (1)

  • Type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities

    November 2007

Secondary Outcomes (2)

  • Pharmacokinetic parameters of SU011248 (and its active metabolite, SU012662), and docetaxel.

    November 2007

  • Objective disease response

    November 2007

Study Arms (1)

1

EXPERIMENTAL

SU011248 in combination with docetaxel

Drug: sunitinibDrug: docetaxel

Interventions

sunitinibDRUG

25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in two different dosing regimens: schedule 2/1 (2 weeks on, 1 week off) and schedule 4/2 (4 weeks on, 2 weeks off)

1
docetaxelDRUG

60, 75, and 100 mg/m2 docetaxel administered every 21 days as a 1-hr IV infusion

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced solid tumor malignancy ECOG 0 or 1

You may not qualify if:

  • Prior treatment with with high-dose chemotherapy requiring stem cell rescue Prior irradiation to ≥25% of the bone marrow (e.g. whole pelvis=25%) Patients with centrally located lung lesions unless recently treated with radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Birmingham, Alabama, 35233-2115, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35294, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Interventions

SunitinibDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 10, 2008

Study Start

July 1, 2004

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

November 11, 2008

Record last verified: 2008-11

Locations

US(5)