XL999 Administered Intravenously to a Subject With Advanced Malignancies

Advanced Malignancy Clinical Trial

Official title:

Single Patient Treatment Study for the Use of XL999 Administered Intravenously to a Subject With Advanced Malignancies Previously Enrolled in Study XL999-900

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT01945164
• Other study ID #: CTRC 10-08
• Secondary ID: HSC20100312H
• Status: No longer available
• Phase: N/A
• First received: December 7, 2012
• Last updated: October 17, 2014
• Start date: April 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2014
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Expanded Access

Clinical Trial Summary

Cancer is a worldwide clinical and economic problem. Conventional approaches to treating cancer include surgery, radiotherapy, and cytotoxic chemotherapy as single modalities or as combined therapies. Recently, targeted therapies including antibodies and small molecule inhibitors have also demonstrated clinical benefit. It is now possible to study different genetic lesions involved in cancer types due to advances in genomic methodologies. The investigational drug in this study, XL999 inhibits multiple receptor tyrosine kinases, including VEGF receptor (VEGFR2/KDR), platelet derived growth factor receptors (PDGFRβ), fms-like tyrosine kinase receptor 3 (FLT3), fibroblast growth factor receptors (FGFR1, FGFR3), RET, and KIT, and thus, interferes with multiple cellular processes simultaneously and will likely have effects on the integrity of tumor neovasculature and angiogenesis. Together with the ability to induce a novel cell cycle arrest, the spectrum of activities that XL999 exhibits may reduce both tumor cell proliferation and angiogenesis in the clinic.

The rationale and purpose of this maintenance study is to allow a subject receiving clinical benefit from XL999 to continue treatment.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject is eligible to continue to receive XL999 in the absence of progressive disease and unacceptable XL999-related toxicity.

Exclusion Criteria:

• Progressive disease.

Study Design

N/A

Related Conditions & MeSH terms

• Advanced Malignancy
• Neoplasms

Intervention

Drug:
• XL999
The treatment will consist of 4-week cycles in which the subject will receive XL999 administered as a 4-hour IV infusion every other week. The subject will continue to receive 4-week cycles of XL999 in the absence of progressive disease, unacceptable drug-related toxicity, and as long as the drug is available.

Locations

Country	Name	City	State
United States	Cancer Therapy and Research Center at UTHSCSA	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
John Sarantopoulos

Country where clinical trial is conducted

United States,