Study of XL999 in Adults With Solid Tumors

NCT00104117 | Completed Phase 1 DMC

• 1 other identifier: XL999-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the safety and tolerability of XL999 in adults with advanced solid tumors.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors

  Inclusion until 30 days post last treatment

Secondary Outcomes (2)

• To evaluate plasma pharmacokinetics (PK) and estimate renal elimination of XL999 administered as a single 4-hour IV infusion in subjects with solid tumors

  Various timepoints from pre-dosing until 48 hours post dose.

• To evaluate the PK of XL999 administered at a fixed weekly dose of 200 mg.

  At various timepoints from pre-dosing until 48 hours post dosing

Interventions

XL999 DRUG

XL999 was to be given biweekly to an initial cohort of subjects at 0.20 mg/kg and to successive cohorts at doses that escalated by cohort according to a design for safely determining an MTD. After determination of the MTD, one or more additional cohorts were to receive XL999 weekly at the MTD or a lower dose, as determined by the CRC on the basis of interim safety and PK data. By a protocol amendment after initiation of the study, subjects were to be enrolled in an additional cohort to receive a weekly XL999 dose of 200 mg.

Eligibility Criteria

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

You may qualify if:

• Advanced solid tumor
• Cancer that has progressed on currently available therapies
• 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

You may not qualify if:

• Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy)
• Radiotherapy within 4 weeks 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

Sponsors & Collaborators

• Symphony Evolution, Inc.: lead

Study Sites (2)

Case Western Reserve University, Univserzity Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cancer Therapy and Research Center, Institute for Drug Development

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Paul Woodard, MD

  Exelixis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 23, 2005
• First Posted: February 24, 2005
• Study Start: November 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: February 19, 2010

Record last verified: 2010-02

Locations

US (2)