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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
  Purpose

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 Intervention 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
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Recurrent Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Symphony Evolution, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: January 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Inc
  More Information

No publications provided

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
Study First Received: January 12, 2006
Last Updated: February 18, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014