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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.
ClinicalTrials.gov 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
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: XL999 Phase 2

Symphony Evolution, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Recurrent Ovarian Cancer
Study Start Date : January 2006
Primary Completion Date : November 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources


Intervention Details:
    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


Primary Outcome Measures :
  1. Response rate [ Time Frame: Inclusion until disease progression ]
  2. Safety and tolerability [ Time Frame: Inclusion until 30 days post last treatment ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Inclusion until disease progression ]
  2. Duration of response [ Time Frame: Inclusion until disease progression ]
  3. Overall survival [ Time Frame: inclusion until 180-Day Follow-up after last treatment or death ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277290


Locations
United States, California
California Cancer Care, Inc.
Greenbrae, California, United States, 94904
United States, Florida
Hematology/Oncology Associates of the Treasure Coast
Port St. Lucie, Florida, United States, 34952
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Joliet Oncology-Hematology Associates, Ltd
Joliet, Illinois, United States, 60435
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Maryland
Harry and Jeanette Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Bradley Cohen
New City, New York, United States, 10956
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Symphony Evolution, Inc.
Investigators
Study Director: Lynne A. Bui, MD Exelixis

Responsible Party: Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
ClinicalTrials.gov Identifier: NCT00277290     History of Changes
Other Study ID Numbers: XL999-202
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: February 22, 2010
Last Verified: February 2010

Keywords provided by Symphony Evolution, Inc.:
Cancer
Recurrent
Platinum-resistant
Platinum-sensitive

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders