CancerPhase 1NCT00526838
Study of XL228 Administered Intravenously to Subjects With Advanced Malignancies
A Phase 1 study testing XL228 in people with Cancer and Lymphoma, run by Exelixis at 4 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of the multi-targeted protein kinase inhibitor XL228 (active against IGF1R, Src, FGFR, and BCR-Abl) administered as a once- or twice-weekly 1-hour intravenous infusion in subjects with advanced malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- XL228
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2007to Dec 2010
- 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
- The subject has a histologically confirmed solid tumor that is metastatic or unresectable, lymphoma, or multiple myeloma, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival. Subjects treated at the MTD (once-weekly) must have a diagnosis of metastice colorectal carcinoma, relapsed or refractory multiple myeloma, non-small-cell lung cancer (NSCLC), or small cell lung cancer (SCLC). Certain other eligibility requirements must also be met.
- The subject has disease that is assessable by tumor marker, clinical laboratory, physical, or radiologic means.
- The subject is ≥18 years old.
- The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- The subject has adequate organ and marrow function.
- The subject is capable of understanding the informed consent document and has signed the informed consent document.
- Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening.
Who cannot join
- The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, investigational agent, or hormones) within 14 days before the first dose of study drug.
- The subject has received radiation to >25% of his or her bone marrow within 30 days of treatment with XL228.
- The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 from adverse events (AEs) due to investigational or other agents administered more than 14 days prior to study enrollment.
- The subject has a primary brain tumor. Subjects with brain metastases are considered eligible if the subject has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks.
- The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- The subject has a psychiatric illness or social situation that would limit compliance with study requirements.
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- The subject is pregnant or breastfeeding.
- The subject is known to be positive for the human immunodeficiency virus (HIV).
- The subject has a known allergy or hypersensitivity to components of the XL228 formulation.
- The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Duke University Medical Center
Durham, North Carolina, 27710
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL228 Administered Intravenously to Subjects With Advanced Malignancies
The purpose of this study is to assess the safety and tolerability of the multi-targeted protein kinase inhibitor XL228 (active against IGF1R, Src, FGFR, and BCR-Abl) administered as a once- or twice-weekly 1-hour intravenous infusion in subjects with advanced malignancies.
- Being tested
- XL228
- Keywords
- Solid Tumor, Multiple Myeloma
- Medical subject headings
- Neoplasms, Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XL228Drug
1-hour IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | once-weekly dosing Receives: Drug: XL228 |
| 2 | Experimental | twice-weekly dosing Receives: Drug: XL228 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of XL228 administered as a once-weekly or twice-weekly 1-hour intravenous (IV) infusion in subjects with advanced malignancies.
Measured: Assessed at periodic visits
To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of XL228 administered as a once- or twice-weekly 1-hour IV infusion in subjects with advanced malignancies.
Measured: Assessed at periodic visits
Secondary outcomes (2)
To evaluate plasma pharmacokinetics of XL228 administered as a once- or twice-weekly 1-hour IV infusion in subjects with advanced malignancies.
Measured: Assessed at periodic visits
To evaluate preliminary safety and efficacy of XL228 when administered at the once-weekly MTD
Measured: Assessed at periodic visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Sponsor decision
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.
- More trials run by ExelixisThe sponsor's other registered studies.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exelixis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526838
- Sponsor's protocol ID
- XL228-002
- Status last verified
- Aug 2015
- First submitted
- 6 Sep 2007
- Last updated
- 21 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. 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 XL228 Administered Intravenously to Subjects With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT00526838
- Acronym / sponsor ID
- XL228-002
- Keywords
- Solid Tumor, Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 84 participants (actual)
- Lead sponsor
- ExelixisIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Sep 2007 (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 the multi-targeted protein kinase inhibitor XL228 (active against IGF1R, Src, FGFR, and BCR-Abl) administered as a once- or twice-weekly 1-hour intravenous infusion in subjects with advanced malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: XL228once-weekly dosing |
| 2 | Experimental | Drug: XL228twice-weekly dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject has a histologically confirmed solid tumor that is metastatic or unresectable, lymphoma, or multiple myeloma, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival. Subjects treated at the MTD (once-weekly) must have a diagnosis of metastice colorectal carcinoma, relapsed or refractory multiple myeloma, non-small-cell lung cancer (NSCLC), or small cell lung cancer (SCLC). Certain other eligibility requirements must also be met.
- The subject has disease that is assessable by tumor marker, clinical laboratory, physical, or radiologic means.
- The subject is ≥18 years old.
- The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- The subject has adequate organ and marrow function.
Key exclusion criteria (10 listed)
- The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, cytokines, investigational agent, or hormones) within 14 days before the first dose of study drug.
- The subject has received radiation to >25% of his or her bone marrow within 30 days of treatment with XL228.
- The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 from adverse events (AEs) due to investigational or other agents administered more than 14 days prior to study enrollment.
- The subject has a primary brain tumor. Subjects with brain metastases are considered eligible if the subject has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks.
- The subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
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 |
|---|---|---|
| XL2281-hour IV infusion | Drug | 1, 2 |
Primary outcome
To assess the safety and tolerability of XL228 administered as a once-weekly or twice-weekly 1-hour intravenous (IV) infusion in subjects with advanced malignancies.
Time frame: Assessed at periodic visits
To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of XL228 administered as a once- or twice-weekly 1-hour IV infusion in subjects with advanced malignancies.
Time frame: Assessed at periodic visits
2 secondary outcomes
To evaluate plasma pharmacokinetics of XL228 administered as a once- or twice-weekly 1-hour IV infusion in subjects with advanced malignancies.
Time frame: Assessed at periodic visits
To evaluate preliminary safety and efficacy of XL228 when administered at the once-weekly MTD
Time frame: Assessed at periodic visits
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 XL228 in people with Cancer and Lymphoma, run by Exelixis at 4 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 10 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 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early (reason given: Sponsor decision). 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?
To assess the safety and tolerability of XL228 administered as a once-weekly or twice-weekly 1-hour intravenous (IV) infusion in subjects with advanced malignancies. (time frame: Assessed at periodic visits). 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 21 Aug 2015.