Maintenance Study on the Long Term Safety of XL999

NCT ID: NCT00955084

Last Updated: 2010-09-24

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

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-05-31

Brief Summary

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The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999.

The secondary objectives of this study are as follows:

* To evaluate tumor response after long term repeat administration of XL999 in two subjects rolled over from other XL999 studies.
* To characterize the long term safety and tolerability of XL999 after repeat administration in two subjects rolled over from other XL999 studies.
* To characterize the long term effects of XL999 on cardiac function after repeat administration in two subjects rolled over from other XL999 studies.

Detailed Description

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Conditions

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Advanced Malignancies

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 for injection will be supplied as a brown, sterile injectable solution at a concentration of 5 mg/mL

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The subject is currently enrolled in Protocols XL999-001 or XL999-204
* The subject has received XL999 for at least one year prior to enrollment
* Per the respective parent XL999 protocol, the subject is eligible to continue to receive XL999 in the absence of progressive disease (PD) or unacceptable drug-related toxicity

Exclusion Criteria

* Progressive disease
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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Charles W. Finn, PhD

Role: STUDY_DIRECTOR

Symphony Evolution, Inc.

Locations

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Hematology Oncology Associates of Rockland Union State Bank Cancer Center

Nyack, New York, United States

Site Status

University of Texas Cancer Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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XL999-900

Identifier Type: -

Identifier Source: org_study_id