Maintenance Study on the Long Term Safety of XL999

A Maintenance Study Evaluating the Long Term Safety of XL999 Administered Intravenously to Subjects With Advanced Malignancies Previously Enrolled in Other XL999 Studies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00955084

Enrollment

Registered

2009-08-07

Start date

2008-08-31

Completion date

2010-05-31

Last updated

2010-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Malignancies

Brief summary

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.

Interventions

DRUGXL999

XL999 for injection will be supplied as a brown, sterile injectable solution at a concentration of 5 mg/mL

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 * Any development(s) that would meet the

Design outcomes

Primary

Measure	Time frame
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.	Progressive disease or end of study

Secondary

Measure	Time frame
Evaluate tumor response after long term repeat administration of XL999 Characterize long term safety and tolerability of XL999 after repeat administration Characterize long term effects of XL999 on cardiac function after repeat administration	Progressive disease or end of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026