TerminatedNCT00277316Updated Feb 19, 2010

Study of XL999 in Patients With Metastatic Renal Cell Carcinoma

A Phase 2 interventional study of XL999 in Renal Cell Carcinoma, sponsored by Symphony Evolution, Inc.. Terminated at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-02-19.

Sponsored by Symphony Evolution, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated

Development of XL999 was stopped due to cardiac toxicities in the subjects

Phase: Phase 2
Study type: Interventional
Enrollment: 11
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with metastatic clear cell renal cell carcinoma (RCC). 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.

Conditions studied

Renal Cell Carcinoma

Browse trials for

Keywords

Kidney cancer
Metastatic

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 11 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Symphony Evolution, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Males and females with histologically confirmed metastatic clear cell RCC
Measurable disease according to Response Criteria for Solid Tumors (RECIST)
No prior systemic cytotoxic chemotherapy
Subjects who have received either no prior therapy for RCC, systemic immunotherapy only (such as interleukin-2 or interferon), or one agent targeting VEGF or a VEGFR (eg, bevacizumab, sorafenib, or sunitinib malate) may be enrolled
ECOG performance status of 0 or 1
Life expectancy ≥3 months
Adequate organ and marrow function
No other malignancies within 5 years
Signed informed consent

Exclusion criteria

Exclusion Criteria:

Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
Subjects who have received systemic anticancer therapy within 30 days of XL999 treatment
Subjects who have not recovered to grade ≤1 or to within 10% of baseline from adverse events due to 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
Pregnant or breastfeeding females
Known HIV

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 11 participants (actual)

Interventions

DrugXL999
Treatment was administered on an outpatient basis. XL999 was administered at a dose of 2.4 mg/kg given as a 4 hour IV infusion.

What researchers measure

Primary outcomes

Response rate
Time frame: Inclusion until disease progression
Safety and tolerability
Time frame: Inclusion until 30 days post last treatment

Secondary outcomes

Progression-free survival
Time frame: Inclusion until disease progression
Duration of response
Time frame: Inclusion until disease progression
Overall survival
Time frame: Inclusion until 180-day Follow-up post last treatment or death
Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters
Time frame: Blood samples for PK/PD analysis will be obtained at the end of infusion for the first 8 weeks of treatment.

Study locations

9 sites

Department of Hematology/Oncology
Los Angeles, California 90095, United States
Stanford Cancer Center
Palo Alto, California 94305, United States
Integrated Community Oncology Network
Jacksonville, Florida 32256, United States
University of Chicago
Chicago, Illinois 60637, United States
Joliet Oncology-Hematology Associates, Ltd
Joliet, Illinois 60435, United States
Division of Hematology/Oncology, Indiana University Cancer Center
Indianapolis, Indiana 46202, United States
The Cleveland Clinic Foundation Taussig Cancer Center
Cleveland, Ohio 44195, United States
Center for Oncology Research and Treatment, PA
Dallas, Texas 75230, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas 76104, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00277316
Lead sponsor: Symphony Evolution, Inc.
First posted: Jan 16, 2006
Start date: Dec 2005
Primary completion: Feb 2007
Completion: Jun 2007
Last update: Feb 19, 2010

Study contacts

Lynne A. Bui, MD

study director · Exelixis

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma→

Other studies from this sponsor

Symphony Evolution, Inc.

Start the discussion