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Study was terminated due to cardiac toxicities in the subjects
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XL999 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Inclusion until disease progression | |
| Safety and tolerability | Inclusion until 30 days post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Inclusion until disease progression | |
| Duration of response | Inclusion until disease progression | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynne A. Bui, MD | Exelixis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Cancer Care, Inc. | Greenbrae | California | 94904 | United States | ||
| Hematology/Oncology Associates of the Treasure Coast |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| inclusion until 180-Day Follow-up after last treatment or death |
| 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 |
| Port Saint Lucie |
| Florida |
| 34952 |
| United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Joliet Oncology-Hematology Associates, Ltd | Joliet | Illinois | 60435 | United States |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Harry and Jeanette Weinberg Cancer Institute at Franklin Square | Baltimore | Maryland | 21237 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Bradley Cohen | New City | New York | 10956 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |