NCT01091207

Brief Summary

With discovery of KIT (CD117) mutations and the advent of KIT tyrosine kinase inhibitor imatinib, there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib showed activity as second-line therapy in GIST patients after failure with imatinib. However, virtually all patients will eventually progress or become intolerable after imatinib and sunitinib. In preclinical models, sorafenib inhibits KIT activity and cell growth of imatinib-resistant tumors. The objective of this multi-center, non-randomized phase II study is to evaluate the safety and activity of sorafenib given as third-line therapy for GIST.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2009

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, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 23, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

Enrollment Period

1.1 years

First QC Date

November 30, 2009

Last Update Submit

January 18, 2012

Conditions

Gastrointestinal Stromal Tumors

Keywords

SorafenibGISTRefractoryadvanced GIST failed after both imatinib and sunitinib

Outcome Measures

Primary Outcomes (1)

  • Disease-control rate

    Six months after registration

Secondary Outcomes (1)

  • Response rate

    Every 2 months

Study Arms (1)

Sorafenib

EXPERIMENTAL

The patients will receive daily oral administration of sorafenib 400 mg twice daily.

Drug: Sorafenib

Interventions

SorafenibDRUG

The patients will receive daily oral administration of sorafenib 400 mg twice daily.

Sorafenib

Eligibility Criteria

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

You may qualify if:

  • age over 18 years
  • advanced GIST
  • failed (progressed and/or intolerable) after prior treatments for GIST
  • ECOG performance status of 0\~2
  • resolution of all toxic effects of prior treatments
  • no prior radiotherapy within 1 month before registration
  • measurable lesion as defined by RECIST
  • adequate marrow, hepatic, renal and cardiac functions
  • provision of a signed written informed consent

You may not qualify if:

  • severe co-morbid illness and/or active infections
  • pregnant or lactating women
  • history of other malignancies
  • active CNS disease not controllable with radiotherapy or corticosteroids
  • active and uncontrollable bleeding from gastrointestinal tract
  • prior history of sorafenib use
  • gastrointestinal obstruction or malabsorption syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135710, South Korea

Location

Related Publications (1)

  • Park SH, Ryu MH, Ryoo BY, Im SA, Kwon HC, Lee SS, Park SR, Kang BY, Kang YK. Sorafenib in patients with metastatic gastrointestinal stromal tumors who failed two or more prior tyrosine kinase inhibitors: a phase II study of Korean gastrointestinal stromal tumors study group. Invest New Drugs. 2012 Dec;30(6):2377-83. doi: 10.1007/s10637-012-9795-9. Epub 2012 Jan 25.

    PMID: 22270258DERIVED

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Se Hoon Park, MD

    Samsung Medical Center, Seoul, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2009

First Posted

March 23, 2010

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

August 1, 2011

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations

KR(1)