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A Phase 2 Study of XL999 Administered Intravenously to Subjects With Recurrent Ovarian Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

A Phase 2 Study of XL999 Administered Intravenously to Subjects With Recurrent Ovarian Cancer


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

Inclusion until disease progression

Safety Issue:

No

Principal Investigator

Lynne A. Bui, MD

Investigator Role:

Study Director

Investigator Affiliation:

Exelixis, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

XL999-202

NCT ID:

NCT00277290

Start Date:

January 2006

Completion Date:

November 2006

Related Keywords:

  • Ovarian Cancer
  • Cancer
  • Recurrent
  • Platinum-resistant
  • Platinum-sensitive
  • Ovarian Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
California Cancer Care, Inc.Greenbrae, California  94904-2007
University of ChicagoChicago, Illinois  60637
Hematology/Oncology Associates of the Treasure CoastPort St. Lucie, Florida  34952
Joliet Oncology-Hematology Associates, LtdJoliet, Illinois  60435
Harry and Jeanette Weinberg Cancer Institute at Franklin SquareBaltimore, Maryland  21237
Bradley CohenNew City, New York  10956