Maintenance Study on the Long Term Safety of XL999

Advanced Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955084
• Other study ID #: XL999-900
• Status: Completed
• Phase: Phase 1
• First received: August 5, 2009
• Last updated: September 23, 2010
• Start date: August 2008
• Est. completion date: May 2010

Study information

• Verified date: September 2010
• Source: Symphony Evolution, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Hematology Oncology Associates of Rockland Union State Bank Cancer Center	Nyack	New York
United States	University of Texas Cancer Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Symphony Evolution, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes