Study of XL820 in Adults With Solid Tumors

A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of XL820 Administered Orally to Subjects With Solid Tumors

The purpose of this study is to assess the safety and tolerability of XL820 when given orally to adults with advanced solid tumors.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: XL820

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • The Cancer Institute of New Jersey
  • Texas
    • San Antonio, Texas, United States, 78229
      • Cancer Therapy and Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Advanced solid tumor
• Cancer for which standard therapies do not exist or are no longer effective
• Life expectancy of > 3 months
• Adequate bone marrow, liver, and kidney function
• Willing to use accepted method of contraception during the course of the study
• Negative pregnancy test (females)
• Written informed consent

Exclusion Criteria:

• Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy)
• Radiotherapy to more than 25% of bone marrow within 4 weeks of the start of treatment
• Investigational drug within 30 days of the start of treatment
• Subjects with known brain metastasis
• Uncontrolled medical disorder such as infection or cardiovascular disease
• Subjects known to be HIV positive
• Pregnant or breastfeeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Exelixis

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: August 10, 2005
• First Submitted That Met QC Criteria: August 10, 2005
• First Posted (Estimate): August 12, 2005

Study Record Updates

• Last Update Posted (Estimate): June 4, 2008
• Last Update Submitted That Met QC Criteria: June 2, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Other Study ID Numbers: XL820-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No