A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or Sunitinib

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

A Phase 2 Study of XL820 in Subjects With Advanced Gastrointestinal Stromal Tumors Resistant to or Intolerant of Imatinib and/or Sunitinib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570635
• Other study ID #: XL820-201
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2007
• Last updated: May 30, 2013
• Start date: December 2007
• Est. completion date: May 2009

Study information

• Verified date: May 2013
• Source: Exelixis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the clinical benefit of the KIT inhibitor XL820 in subjects with advanced gastrointestinal stromal tumors (GIST) who are resistant to or intolerant of Imatinib and/or Sunitinib.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with metastatic or locally advanced or unresectable GIST who have intolerance of or disease progression following prior treatment with imatinib and/or sunitinib

• ECOG (Eastern Cooperative Oncology Group) performance status =2

• Must have measurable disease per RECIST (Response Evaluation Criteria in Solid Tumors)

• Recovery from toxicity from prior therapy to Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade =1 or to subject's baseline status

• Adequate organ and marrow function

• Sexually active subjects (male and female) must agree to use accepted methods of contraception during the course of the study and for 3 months following discontinuation of study drugs.

• Female subjects of childbearing potential must have a negative pregnancy test at enrollment.

Exclusion Criteria:

• Therapy with imatinib or sunitinib within 14 days before the first dose of study drug

• Chemotherapy, immunotherapy, targeted therapy, chemoembolization, or any investigational drug for the treatment of GIST after the last dose of imatinib or sunitinib

• Anticoagulation with warfarin or coumarin-related compounds

• Radiation to =25% of bone marrow within 28 days of study entry

• Treatment with other investigational agents within 28 days of the first dose of XL820

• Known central nervous systems metastases

• Uncontrolled or intercurrent illness

• Pregnancy or breast-feeding

• Active bacterial or viral infection requiring systemic treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Gastrointestinal Stromal Tumors

Intervention

Drug:
• XL820
XL820 capsules administered orally as a single agent at a dose of 800 mg daily
• XL820
XL820 capsules administered orally as a single agent at a dose of 300 mg twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Exelixis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical benefit, defined as either confirmed complete response, confirmed partial response, or evidence of stable disease lasting =16 weeks, in subjects with advanced GIST resistant to/intolerant of imatinib and/or sunitinib		Assessed at baseline, Week 4 and 8, and every 8 weeks thereafter	No
Secondary	Safety and tolerability of XL820		Assessed at each visit	Yes
Secondary	Progression-free survival, duration of response, and overall survival		Assessed until progression	No
Secondary	Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST		Assessed during periodic visits	No