Colorectal CancerPhase 2NCT00277303
Study of XL999 in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing XL999 in people with Colorectal Cancer, run by Symphony Evolution, Inc. at 8 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 colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- XL999
- Type of treatment
- Injection or infusion
- How many people
- 17 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2005to Feb 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 colorectal cancer
- Measurable disease according to Response Criteria for Solid Tumors (RECIST)
- At least 1 prior therapeutic regimen (chemotherapy or biologic)
- 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
Who cannot join
- Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
- Treatment with systemic anticancer therapy within 30 days of XL999 treatment
- 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
- Pregnant or breastfeeding females
- Known HIV
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Chicago
Chicago, Illinois, 60637
Center for Oncology Research and Treatment, PA
Dallas, Texas, 75230
California Cancer Care, Inc.
Greenbrae, California, 94904
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Integrated Community Oncology Network; Division of Clinical Research
Jacksonville, Florida, 32256
Joliet Oncology-Hematology Associated, Ltd.
Joliet, Illinois, 60435
Hematology Oncology Associates of Rockland, PC
New City, New York, 10956
Hematology Oncology Associated of the Treasure Coast
Port Saint Lucie, Florida, 34952
About this study
Official title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Colorectal Cancer
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 colorectal cancer (CRC). 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
- Colorectal Cancer
- Being tested
- XL999
- Keywords
- Colon Cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XL999Drug
XL999 will be administered at 2.4 mg/kg as a 4-hour intravenous (IV) infusion. Subjects will receive XL999 infusions weekly for 8 weeks of treatment unless drug-related toxicity requires dosing delay. In the absence of progressive disease and unacceptable toxicity, subjects may receive XL999 treatment weekly for up to a year on this study. After 8 weeks, at the discretion of the investigator, one dose of four may be omitted for a subject's convenience.
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 last Follow-up post last treatment or death
Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters
Measured: Samples will be collected pre-dose and immediately at the end for subjects in the second stage of the study
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 completionAug 2006
- Study completionFeb 2007
Why it stopped: Study was terminated 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 Colorectal CancerStudies 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symphony Evolution, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lynne Bui, MD, Study director, Exelixis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277303
- Sponsor's protocol ID
- XL999-206
- Status last verified
- Feb 2010
- First submitted
- 12 Jan 2006
- Last updated
- 22 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 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 Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00277303
- Acronym / sponsor ID
- XL999-206
- Conditions
- Colorectal Cancer
- Keywords
- Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to cardiac toxicities in the subjects
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Symphony Evolution, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Feb 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 colorectal cancer (CRC). 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 (8 listed)
- Males and females with histologically confirmed metastatic colorectal cancer
- Measurable disease according to Response Criteria for Solid Tumors (RECIST)
- At least 1 prior therapeutic regimen (chemotherapy or biologic)
- ECOG performance status of 0 or 1
- Life expectancy ≥3 months
Key exclusion criteria (7 listed)
- Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
- Treatment with systemic anticancer therapy within 30 days of XL999 treatment
- 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
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 |
|---|---|---|
| XL999XL999 will be administered at 2.4 mg/kg as a 4-hour intravenous (IV) infusion. Subjects will receive XL999 infusions weekly for 8 weeks of treatment unless drug-related toxicity requires dosing delay. In the absence of progressive disease and unacceptable toxicity, subjects may receive XL999 treatment weekly for up to a year on this study. After 8 weeks, at the discretion of the investigator, one dose of four may be omitted for a subject's convenience. | 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 last Follow-up post last treatment or death
Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters
Time frame: Samples will be collected pre-dose and immediately at the end for subjects in the second stage of the study
Results and safety
The study was stopped early (reason given: Study was terminated 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 22 Feb 2010.
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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 Bui, MD study director
Exelixis
8 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 Colorectal Cancer, run by Symphony Evolution, Inc. at 8 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 8 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 22 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 8 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: Study was terminated 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 22 Feb 2010.