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Completed

NCT Number: NCT00955084

Maintenance Study on the Long Term Safety of XL999

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.

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Key information

Conditions

Advanced Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hematology Oncology Associates of Rockland Union State Bank Cancer Center, Nyack, New York, 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

  • 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 exclusion criteria from the subject's respective XL999 protocol (XL999-001 or XL999-204)

Treatment and study plan

XL999

Drug

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

Primary outcomes

  1. 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.

    Time frame: Progressive disease or end of study

Secondary outcomes

  1. 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

    Time frame: Progressive disease or end of study

Sponsors and collaborators

Lead sponsor

Symphony Evolution, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 7, 2009
Registry last updated
Sep 24, 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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