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Study of XL999 in Patients With Previously Treated Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
XL999
Sponsored by
Symphony Evolution, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Cancer, Recurrent, Platinum-resistant, Platinum-sensitive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • California Cancer Care, Inc.
  • Hematology/Oncology Associates of the Treasure Coast
  • University of Chicago
  • Joliet Oncology-Hematology Associates, Ltd
  • Indiana University Cancer Center
  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square
  • Dana-Farber Cancer Institute
  • Bradley Cohen
  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Response rate
Safety and tolerability

Secondary Outcome Measures

Progression-free survival
Duration of response
Overall survival
Pharmacokinetic (PK) and pharmacodynamics (PD) parameters

Full Information

First Posted
January 12, 2006
Last Updated
February 18, 2010
Sponsor
Symphony Evolution, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00277290
Brief Title
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

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to cardiac toxicities in the subjects
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Symphony Evolution, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Cancer, Recurrent, Platinum-resistant, Platinum-sensitive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
XL999
Intervention Description
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
Primary Outcome Measure Information:
Title
Response rate
Time Frame
Inclusion until disease progression
Title
Safety and tolerability
Time Frame
Inclusion until 30 days post last treatment
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Inclusion until disease progression
Title
Duration of response
Time Frame
Inclusion until disease progression
Title
Overall survival
Time Frame
inclusion until 180-Day Follow-up after last treatment or death
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne A. Bui, MD
Organizational Affiliation
Exelixis
Official's Role
Study Director
Facility Information:
Facility Name
California Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Hematology/Oncology Associates of the Treasure Coast
City
Port St. Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Joliet Oncology-Hematology Associates, Ltd
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Harry and Jeanette Weinberg Cancer Institute at Franklin Square
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Bradley Cohen
City
New City
State/Province
New York
ZIP/Postal Code
10956
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of XL999 in Patients With Previously Treated Ovarian Cancer

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