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Sorafenib for Imatinib/Sunitinib-failed GIST

This study has been completed.
Sponsor:
Collaborator:
Korean GIST Study Group
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01091207
First received: November 30, 2009
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Stromal Tumors
 Drug: Sorafenib
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Sorafenib in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors Who Failed to Imatinib and Sunitinib

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Disease-control rate [ Time Frame: Six months after registration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib
The patients will receive daily oral administration of sorafenib 400 mg twice daily.
 Drug: Sorafenib
The patients will receive daily oral administration of sorafenib 400 mg twice daily.

Detailed Description:

This is a non-randomized, open-label, multi-center, phase II study recruiting patients with advanced GIST who are pretreated with both imatinib and sunitinib. The current study will provide an estimate of the activity and safety of sorafenib in GIST. The primary study endpoint is the disease control rate (DCR), defined as complete or partial response or stable disease of at least 24 weeks of sorafenib therapy. Secondary endpoints include PFS, OS and safety.

Patients with advanced (unresectable and/or metastatic) GIST who failed after previous therapy involving both imatinib and sunitinib will be eligible. Failure to imatinib and sunitinib is defined as disease progression regardless of intervening response during therapy, or intolerance. There is no limit to the number of prior therapies a patient may have received (e.g., patients may have received therapy with nilotinib, other TKIs, or chemotherapy in addition to imatinib or sunitinib).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091207

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135710
Sponsors and Collaborators
Samsung Medical Center
Korean GIST Study Group
Investigators
Principal Investigator: Se Hoon Park, MD Samsung Medical Center, Seoul, Korea
  More Information

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Se Hoon Park, Samsung Medical Center, Seoul, Korea
ClinicalTrials.gov Identifier: NCT01091207     History of Changes
Other Study ID Numbers: 2009-08-102
Study First Received: November 30, 2009
Last Updated: January 18, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:
Sorafenib
GIST
Refractory
advanced GIST failed after both imatinib and sunitinib

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Sorafenib
Sunitinib
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013