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Study of XL999 in Patients With Previously Treated Ovarian Cancer

This study has been terminated.
(Study was terminated due to cardiac toxicities in the subjects)
Sponsor:
Information provided by:
Symphony Evolution, Inc.
ClinicalTrials.gov Identifier:
NCT00277290
First received: January 12, 2006
Last updated: February 18, 2010
Last verified: February 2010

January 12, 2006
February 18, 2010
January 2006
November 2006   (final data collection date for primary outcome measure)
  • Response rate [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Inclusion until 30 days post last treatment ] [ Designated as safety issue: Yes ]
  • Response rate
  • Safety and tolerability
Complete list of historical versions of study NCT00277290 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Inclusion until disease progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: inclusion until 180-Day Follow-up after last treatment or death ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Progression-free survival
  • Duration of response
  • Overall survival
  • Pharmacokinetic (PK) and pharmacodynamics (PD) parameters
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00277290
XL999-202
Yes
Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
Symphony Evolution, Inc.
Not Provided
Study Director: Lynne A. Bui, MD Exelixis, Inc
Symphony Evolution, Inc.
February 2010

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