Study of XL999 in Patients With Previously Treated Ovarian Cancer

Phase 2

Terminated

• Conditions: Ovarian Cancer

• Registration Number: NCT00277290
• Lead Sponsor: Symphony Evolution, Inc.

Brief Summary

This clinical trial is being conducted at multiple sites to evaluate the activity, safety, and tolerability of XL999 when given weekly to patients with ovarian cancer that has previously been treated with platinum-based chemotherapy. XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-16
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-18
• Last Update Posted: 2010-02-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Female patients with a histologically confirmed diagnosis of metastatic ovarian cancer
• Measurable disease according to Response Criteria for Solid Tumors (RECIST)
• Prior treatment with platinum-based therapy
• Platinum-sensitive or platinum-resistant disease
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of ≥3 months
• Adequate organ and marrow function
• Signed informed consent
• No other malignancies within 5 years

Exclusion Criteria

• Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
• Use of an investigational drug or cytotoxic chemotherapy within 30 days of XL999 treatment
• Prior anticancer therapy targeting VEGF (eg, bevacizumab, sorafenib, or sunitinib)
• More than two prior systemic non-platinum cytotoxic chemotherapy regimens
• Subject has not recovered to grade ≤1 or to within 10% of baseline from adverse events due to other medications administered >30 days prior to study enrollment
• History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis
• Uncontrolled and/or intercurrent illness
• Patients who are pregnant or breastfeeding
• Known human immunodeficiency virus (HIV)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate	Inclusion until disease progression
Safety and tolerability	Inclusion until 30 days post last treatment

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Inclusion until disease progression
Duration of response	Inclusion until disease progression
Overall survival	inclusion until 180-Day Follow-up after last treatment or death
Pharmacokinetic (PK) and pharmacodynamics (PD) parameters	Samples will be collected pre-dose and immediatelyat the end of infusion for the 8-week Study Treatment Period for subjects in the second stage of the study

Trial Locations

Locations (9)

Hematology/Oncology Associates of the Treasure Coast; 🇺🇸 Port St. Lucie, Florida, United States

Bradley Cohen; 🇺🇸 New City, New York, United States

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Harry and Jeanette Weinberg Cancer Institute at Franklin Square; 🇺🇸 Baltimore, Maryland, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

California Cancer Care, Inc.; 🇺🇸 Greenbrae, California, United States

Joliet Oncology-Hematology Associates, Ltd; 🇺🇸 Joliet, Illinois, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States