XL999 Administered Intravenously to a Subject With Advanced Malignancies

NCT ID: NCT01945164

Last Updated: 2014-10-21

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-06-30

Brief 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.

Conditions

Advanced Malignancy

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

John Sarantopoulos

OTHER

Sponsor Role: lead

Responsible Party

John Sarantopoulos

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Sarantopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

Cancer Therapy and Research Center at UTHSCSA

San Antonio, Texas, United States

Countries

United States

Other Identifiers

HSC20100312H

Identifier Type: OTHER

Identifier Source: secondary_id

CTRC 10-08

Identifier Type: -

Identifier Source: org_study_id