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Maintenance Study on the Long Term Safety of XL999

Sponsor
Symphony Evolution, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00955084
Collaborator
(none)
2
Enrollment
2
Locations
21
Duration (Months)
1
Patient Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
May 1, 2010

Outcome Measures

Primary Outcome Measures

  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. [Progressive disease or end of study]

Secondary Outcome Measures

  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 [Progressive disease or end of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hematology Oncology Associates of Rockland Union State Bank Cancer Center Nyack New York United States 10960
2 University of Texas Cancer Center San Antonio Texas United States 78229

Sponsors and Collaborators

  • Symphony Evolution, Inc.

Investigators

  • Study Director: Charles W. Finn, PhD, Symphony Evolution, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00955084
Other Study ID Numbers:
  • XL999-900
First Posted:
Aug 7, 2009
Last Update Posted:
Sep 24, 2010
Last Verified:
Sep 1, 2010
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Sep 24, 2010