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

NCT00570635 | Completed Phase 2 DMC

• 1 other identifier: XL820-201
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Gastrointestinal Stromal Tumors; Gastrointestinal Neoplasms

Keywords

GIST; Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Safety and tolerability of XL820

  Assessed at each visit

• Progression-free survival, duration of response, and overall survival

  Assessed until progression

• Further characterize the pharmacokinetic and pharmacodynamic parameters of XL820 in subjects with advanced GIST

  Assessed during periodic visits

Study Arms (2)

A

EXPERIMENTAL

Drug: XL820

B

EXPERIMENTAL

Drug: XL820

Interventions

XL820 DRUG

XL820 capsules administered orally as a single agent at a dose of 800 mg daily

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Exelixis: lead

Study Sites (3)

Unknown Facility

Los Angeles, California, 90095, United States

Location

Unknown Facility

Park Ridge, Illinois, 60068, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 11, 2007
• Study Start: December 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 7, 2013

Record last verified: 2013-05

Locations

US (3)