NCT00277290

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 ovarian-cancer

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2 ovarian-cancer

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

February 22, 2010

Status Verified

February 1, 2010

Enrollment Period

10 months

First QC Date

January 12, 2006

Last Update Submit

February 18, 2010

Conditions

Ovarian Cancer

Keywords

CancerRecurrentPlatinum-resistantPlatinum-sensitive

Outcome Measures

Primary Outcomes (2)

  • Response rate

    Inclusion until disease progression

  • Safety and tolerability

    Inclusion until 30 days post last treatment

Secondary Outcomes (4)

  • Progression-free survival

    Inclusion until disease progression

  • Duration of response

    Inclusion until disease progression

  • Overall survival

    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

Interventions

XL999DRUG

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

California Cancer Care, Inc.

Greenbrae, California, 94904, United States

Location

Hematology/Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Joliet Oncology-Hematology Associates, Ltd

Joliet, Illinois, 60435, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Harry and Jeanette Weinberg Cancer Institute at Franklin Square

Baltimore, Maryland, 21237, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Bradley Cohen

New City, New York, 10956, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsNeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lynne A. Bui, MD

    Exelixis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Expanded Access
Yes

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 16, 2006

Study Start

January 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

February 22, 2010

Record last verified: 2010-02

Locations

US(9)