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Completed

NCT Number: NCT00104117

Study of XL999 in Adults With Solid Tumors

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

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Case Western Reserve University, Univserzity Hospitals of Cleveland, Cleveland, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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

    Time frame: Inclusion until 30 days post last treatment

Secondary outcomes

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

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

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

    Time frame: At various timepoints from pre-dosing until 48 hours post dosing

Sponsors and collaborators

Lead sponsor

Symphony Evolution, Inc.

Industry

Registry information

Official study title

A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Feb 24, 2005
Registry last updated
Feb 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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