Study of XL999 in Patients With Previously Treated Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00277290
• Other study ID #: XL999-202
• Status: Terminated
• Phase: Phase 2
• First received: January 12, 2006
• Last updated: February 18, 2010
• Start date: January 2006
• Est. completion date: November 2006

Study information

• Verified date: February 2010
• Source: Symphony Evolution, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Harry and Jeanette Weinberg Cancer Institute at Franklin Square	Baltimore	Maryland
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	California Cancer Care, Inc.	Greenbrae	California
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Joliet Oncology-Hematology Associates, Ltd	Joliet	Illinois
United States	Bradley Cohen	New City	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Hematology/Oncology Associates of the Treasure Coast	Port St. Lucie	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Symphony Evolution, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Inclusion until disease progression	No
Primary	Safety and tolerability		Inclusion until 30 days post last treatment	Yes
Secondary	Progression-free survival		Inclusion until disease progression	No
Secondary	Duration of response		Inclusion until disease progression	No
Secondary	Overall survival		inclusion until 180-Day Follow-up after last treatment or death	No
Secondary	Pharmacokinetic (PK) and pharmacodynamics (PD) parameters		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	Yes