Maintenance Study on the Long Term Safety of XL999

This study has been completed.
Sponsor:
Information provided by:
Symphony Evolution, Inc.
ClinicalTrials.gov Identifier:
NCT00955084
First received: August 5, 2009
Last updated: September 23, 2010
Last verified: September 2010
  Purpose

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 Intervention Phase
Advanced Malignancies
Drug: XL999
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Symphony Evolution, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: August 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: XL999
    XL999 for injection will be supplied as a brown, sterile injectable solution at a concentration of 5 mg/mL
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955084

Locations
United States, New York
Hematology Oncology Associates of Rockland Union State Bank Cancer Center
Nyack, New York, United States, 10960
United States, Texas
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.
  More Information

No publications provided

Responsible Party: Charles W Finn, Symphony Evolution, Inc.
ClinicalTrials.gov Identifier: NCT00955084     History of Changes
Other Study ID Numbers: XL999-900
Study First Received: August 5, 2009
Last Updated: September 23, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014