Study of XL999 in Adults With Solid Tumors

NCT ID: NCT00104117

Last Updated: 2010-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2008-10-31

Brief Summary

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

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Symphony Evolution, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Symphony Evolution, Inc.

Principal Investigators

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Paul Woodard, MD

Role: STUDY_DIRECTOR

Exelixis

Locations

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Case Western Reserve University, Univserzity Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Cancer Therapy and Research Center, Institute for Drug Development

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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XL999-001

Identifier Type: -

Identifier Source: org_study_id

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