Clinical trial NCT00277290: Study of XL999 in Patients With Previously Treated Ovarian Cancer
Official title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Recurrent Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Cancer
Recurrent
Platinum-resistant
Platinum-sensitive
Lead sponsor: Symphony Evolution, Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-16
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Response rate
timeFrame: Inclusion until disease progression
measure: Safety and tolerability
timeFrame: Inclusion until 30 days post last treatment
Secondary outcomes:
measure: Progression-free survival
timeFrame: Inclusion until disease progression
measure: Duration of response
timeFrame: Inclusion until disease progression
measure: Overall survival
timeFrame: inclusion until 180-Day Follow-up after last treatment or death
measure: Pharmacokinetic (PK) and pharmacodynamics (PD) parameters
timeFrame: 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
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: California Cancer Care, Inc.
state: California
city: Port St. Lucie
country: United States
facility: Hematology/Oncology Associates of the Treasure Coast
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates, Ltd
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Cancer Center
state: Indiana
city: Baltimore
country: United States
facility: Harry and Jeanette Weinberg Cancer Institute at Franklin Square
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New City
country: United States
facility: Bradley Cohen
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Exelixis
name: Lynne A. Bui, MD
role: STUDY_DIRECTOR
References: