NCT00400569

Brief Summary

This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity. All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma, liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

November 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
9 months until next milestone

Results Posted

Study results publicly available

August 28, 2012

Completed
Last Updated

August 28, 2012

Status Verified

July 1, 2012

Enrollment Period

5.1 years

First QC Date

November 15, 2006

Results QC Date

July 25, 2012

Last Update Submit

July 25, 2012

Conditions

LiposarcomaLeiomyosarcomaFibrosarcomaMalignant Fibrous Histiocytoma

Keywords

Sunitinib malateSUTENTSU011248Soft tissue sarcomaGastrointestinal stromal tumors (GIST)MFHTyrosine kinase inhibitorImatinib mesylatePhase II

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Overall Response (OR)

    Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).

    From On Treatment to Off Study - average of 6 months

Secondary Outcomes (3)

  • Participants' Progression Free Survival (PFS)

    From On Treatment to Off Study - average of 6 months

  • Participants' Overall Survival (OS)

    From On Treatment to Off Study - average of 6 months

  • Number of Participants With Serious Adverse Events (SAEs)

    4 years, 7 months

Study Arms (1)

Sunitinib Malate (SU011248) Treatment

EXPERIMENTAL

Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks

Drug: Sunitinib Malate (SU011248)

Interventions

Sunitinib Malate (SU011248)DRUG

For each 6 week cycle, patients will take SU011248 every day in the morning for 4 weeks followed by a 2 week rest period.

Also known as: Sutent, SU011248
Sunitinib Malate (SU011248) Treatment

Eligibility Criteria

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

You may qualify if:

  • Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade less than or equal to 1.
  • Adequate organ function as defined by the following criteria:
  • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
  • Total serum bilirubin less than or equal to 1.5 x ULN
  • Absolute neutrophil count (ANC) greater than or equal to1500/microL
  • Platelets greater than or equal to 100,000/microL
  • Hemoglobin greater than or equal to 9.0 g/dL
  • Serum calcium less than or equal to 12.0 mg/dL
  • Serum creatinine less than or equal to 1.5 x ULN
  • Histologically-proven liposarcoma, leiomyosarcoma, fibrosarcoma, or MFH
  • Measurable disease radiographically
  • Disease that is deemed surgically unresectable and/or metastatic
  • Age greater than or equal to 18 years
  • Life expectancy greater than 16 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  • +1 more criteria

You may not qualify if:

  • Major surgery or radiation therapy or chemotherapy within 4 weeks of starting the study treatment.
  • NCI CTCAE version 3 grade 3 hemorrhage within 4 weeks of starting the study treatment.
  • History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease.
  • Any of the following within the 6 months prior to study drug administration:
  • myocardial infarction,
  • severe/unstable angina,
  • coronary/peripheral artery bypass graft,
  • symptomatic congestive heart failure,
  • cerebrovascular accident or transient ischemic attack, or pulmonary embolism
  • Ongoing cardiac dysrhythmias of NCI CTCAE greater than or equal to grade 2
  • Prolonged QTc interval on baseline electrocardiogram (ECG) \> 500 msec.
  • Hypertension that cannot be controlled by medications (\>150/100 mm Hg despite optimal medical therapy)
  • Prior tyrosine kinase inhibitor therapy
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

LiposarcomaLeiomyosarcomaFibrosarcomaHistiocytoma, Malignant FibrousSarcomaGastrointestinal Stromal Tumors

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms, Adipose TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Muscle TissueNeoplasms, Fibrous TissueNeoplasms, Connective TissueHistiocytomaGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

The trial was amended to exclude fibrosarcoma after only one patient was accrued while the other cohorts had completed 75% or more of their planned accrual. Only patients with liposarcoma, leiomyosarcoma, or MFH were enrolled after this amendment.

Results Point of Contact

Title
Alberto Chiappori, M.D.
Organization
H. Lee Moffitt Cancer Center and Research Institute
alberto.chiappori@moffitt.org
813-745-2158

Study Officials

  • Alberto Chiappori, M.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 17, 2006

Study Start

November 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 28, 2012

Results First Posted

August 28, 2012

Record last verified: 2012-07

Locations

US(1)