Study of XL999 in Patients With Previously Treated Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00277290
Recruitment Status : Terminated (Study was terminated due to cardiac toxicities in the subjects)
First Posted : January 16, 2006
Last Update Posted : February 22, 2010
Information provided by:
Symphony Evolution, Inc.

January 12, 2006
January 16, 2006
February 22, 2010
January 2006
November 2006   (Final data collection date for primary outcome measure)
  • Response rate [ Time Frame: Inclusion until disease progression ]
  • Safety and tolerability [ Time Frame: Inclusion until 30 days post last treatment ]
  • Response rate
  • Safety and tolerability
Complete list of historical versions of study NCT00277290 on Archive Site
  • Progression-free survival [ Time Frame: Inclusion until disease progression ]
  • Duration of response [ Time Frame: Inclusion until disease progression ]
  • Overall survival [ Time Frame: inclusion until 180-Day Follow-up after last treatment or death ]
  • Pharmacokinetic (PK) and pharmacodynamics (PD) parameters [ Time Frame: 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 ]
  • Progression-free survival
  • Duration of response
  • Overall survival
  • Pharmacokinetic (PK) and pharmacodynamics (PD) parameters
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Study of XL999 in Patients With Previously Treated Ovarian Cancer
A Phase 2 Study of XL999 Administered Intravenously to Subjects With Recurrent Ovarian Cancer
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.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ovarian Cancer
Drug: XL999
Treatment was administered on an outpatient basis. XL999 was administered at 2.4 mg/kg as a 4 hour intravenous (IV) infusion. Subjects received a XL999 infusion once a week for 8 weeks of treatment unless drug-related toxicity required a dosing delay
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2006
November 2006   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
Symphony Evolution, Inc.
Not Provided
Study Director: Lynne A. Bui, MD Exelixis
Symphony Evolution, Inc.
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP