Study of XL999 in Adults With Solid Tumors

This study has been completed.

Sponsor:

Information provided by:

Symphony Evolution, Inc.

ClinicalTrials.gov Identifier:

NCT00104117

First received: February 23, 2005

Last updated: February 18, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2005

Last Updated Date

February 18, 2010

Start Date ^ICMJE

November 2004

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00104117 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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: inclusion until 30 days post last treatment ] [ Designated as safety issue: Yes ]
To evaluate the PK of XL999 administered at a fixed weekly dose of 200 mg. [ Time Frame: Inclusion until 30 days post last treatment ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study of XL999 in Adults With Solid Tumors

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cancer

Intervention ^ICMJE

Drug: XL999

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.

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00104117

Other Study ID Numbers ^ICMJE

XL999-001

Has Data Monitoring Committee

Yes

Responsible Party

Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.

Study Sponsor ^ICMJE

Symphony Evolution, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Paul Woodard, MD

Exelixis, Inc.

Information Provided By

Symphony Evolution, Inc.

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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