Renal Cell CarcinomaPhase 2NCT00277316
Study of XL999 in Patients With Metastatic Renal Cell Carcinoma
A Phase 2 study testing XL999 in people with Renal Cell Carcinoma, run by Symphony Evolution, Inc. at 9 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- XL999
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- 9 sitesUnited States
- Study dates
- Dec 2005to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Adequate organ and marrow function
- No other malignancies within 5 years
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Chicago
Chicago, Illinois, 60637
The Cleveland Clinic Foundation Taussig Cancer Center
Cleveland, Ohio, 44195
Center for Oncology Research and Treatment, PA
Dallas, Texas, 75230
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Division of Hematology/Oncology, Indiana University Cancer Center
Indianapolis, Indiana, 46202
Integrated Community Oncology Network
Jacksonville, Florida, 32256
Joliet Oncology-Hematology Associates, Ltd
Joliet, Illinois, 60435
Department of Hematology/Oncology
Los Angeles, California, 90095
Stanford Cancer Center
Palo Alto, California, 94305
About this study
Official title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma
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
- Renal Cell Carcinoma
- Being tested
- XL999
- Keywords
- Kidney cancer, Metastatic
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XL999Drug
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 is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: Inclusion until disease progression
Safety and tolerability
Measured: Inclusion until 30 days post last treatment
Secondary outcomes (4)
Progression-free survival
Measured: Inclusion until disease progression
Duration of response
Measured: Inclusion until disease progression
Overall survival
Measured: Inclusion until 180-day Follow-up post last treatment or death
Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters
Measured: Blood samples for PK/PD analysis will be obtained at the end of infusion for the first 8 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionFeb 2007
- Study completionJun 2007
Why it stopped: Development of XL999 was stopped due to cardiac toxicities in the subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symphony Evolution, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lynne A. Bui, MD, Study director, Exelixis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277316
- Sponsor's protocol ID
- XL999-201
- Status last verified
- Feb 2010
- First submitted
- 12 Jan 2006
- Last updated
- 19 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00277316
- Acronym / sponsor ID
- XL999-201
- Conditions
- Renal Cell Carcinoma
- Keywords
- Kidney cancer, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development of XL999 was stopped due to cardiac toxicities in the subjects
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Symphony Evolution, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 16 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XL999Treatment was administered on an outpatient basis. XL999 was administered at a dose of 2.4 mg/kg given as a 4 hour IV infusion. | Drug | – |
Primary outcome
Response rate
Time frame: Inclusion until disease progression
Safety and tolerability
Time frame: Inclusion until 30 days post last treatment
4 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.
Results and safety
The study was stopped early (reason given: Development of XL999 was stopped due to cardiac toxicities in the subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2010.
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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynne A. Bui, MD study director
Exelixis
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XL999 in people with Renal Cell Carcinoma, run by Symphony Evolution, Inc. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Development of XL999 was stopped due to cardiac toxicities in the subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Inclusion until disease progression). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2010.