CancerPhase 1NCT00104117
Study of XL999 in Adults With Solid Tumors
A Phase 1 study testing XL999 in people with Cancer, run by Symphony Evolution, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of XL999 in adults with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- XL999
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2004to Oct 2008
- Phase
- Phase 1
- 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
- Advanced solid tumor
- Cancer that has progressed on currently available therapies
- Life expectancy of >3 months
- Adequate bone marrow, liver, and kidney function
- Willing to use accepted method of contraception during the course of the study
- Negative pregnancy test (females)
- Written informed consent
Who cannot join
- Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy)
- Radiotherapy within 4 weeks of the start of treatment
- Subjects with known brain metastasis
- Uncontrolled medical disorder such as infection or cardiovascular disease
- Subjects known to be HIV positive
- Pregnant or breastfeeding women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Case Western Reserve University, Univserzity Hospitals of Cleveland
Cleveland, Ohio, 44106
Cancer Therapy and Research Center, Institute for Drug Development
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors
The purpose of this study is to assess the safety and tolerability of XL999 in adults with advanced solid tumors.
- Conditions
- Cancer
- Being tested
- XL999
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XL999Drug
XL999 was to be given biweekly to an initial cohort of subjects at 0.20 mg/kg and to successive cohorts at doses that escalated by cohort according to a design for safely determining an MTD. After determination of the MTD, one or more additional cohorts were to receive XL999 weekly at the MTD or a lower dose, as determined by the CRC on the basis of interim safety and PK data. By a protocol amendment after initiation of the study, subjects were to be enrolled in an additional cohort to receive a weekly XL999 dose of 200 mg.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors
Measured: Inclusion until 30 days post last treatment
Secondary outcomes (2)
To evaluate plasma pharmacokinetics (PK) and estimate renal elimination of XL999 administered as a single 4-hour IV infusion in subjects with solid tumors
Measured: Various timepoints from pre-dosing until 48 hours post dose.
To evaluate the PK of XL999 administered at a fixed weekly dose of 200 mg.
Measured: At various timepoints from pre-dosing until 48 hours post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2005 (estimated)
- Study startNov 2004
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symphony Evolution, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul Woodard, MD, Study director, Exelixis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104117
- Sponsor's protocol ID
- XL999-001
- Status last verified
- Feb 2010
- First submitted
- 23 Feb 2005
- 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 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT00104117
- Acronym / sponsor ID
- XL999-001
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Symphony Evolution, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 24 Feb 2005 (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.
The purpose of this study is to assess the safety and tolerability of XL999 in adults with advanced solid tumors.
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 (7 listed)
- Advanced solid tumor
- Cancer that has progressed on currently available therapies
- Life expectancy of >3 months
- Adequate bone marrow, liver, and kidney function
- Willing to use accepted method of contraception during the course of the study
Key exclusion criteria (6 listed)
- Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy)
- Radiotherapy within 4 weeks of the start of treatment
- Subjects with known brain metastasis
- Uncontrolled medical disorder such as infection or cardiovascular disease
- Subjects known to be HIV positive
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 was to be given biweekly to an initial cohort of subjects at 0.20 mg/kg and to successive cohorts at doses that escalated by cohort according to a design for safely determining an MTD. After determination of the MTD, one or more additional cohorts were to receive XL999 weekly at the MTD or a lower dose, as determined by the CRC on the basis of interim safety and PK data. By a protocol amendment after initiation of the study, subjects were to be enrolled in an additional cohort to receive a weekly XL999 dose of 200 mg. | Drug | – |
Primary outcome
To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors
Time frame: Inclusion until 30 days post last treatment
2 secondary outcomes
To evaluate plasma pharmacokinetics (PK) and estimate renal elimination of XL999 administered as a single 4-hour IV infusion in subjects with solid tumors
Time frame: Various timepoints from pre-dosing until 48 hours post dose.
To evaluate the PK of XL999 administered at a fixed weekly dose of 200 mg.
Time frame: At various timepoints from pre-dosing until 48 hours post dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 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.
Paul Woodard, MD study director
Exelixis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XL999 in people with Cancer, run by Symphony Evolution, Inc. at 2 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 7 inclusion and 6 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: finished, 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 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors (time frame: Inclusion until 30 days post last treatment). 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.