Non-small Cell Lung CancerPhase 2NCT00277329
Study of XL999 in Patients With Non-small Cell Lung Cancer
A Phase 2 study testing XL999 in people with Non-small Cell Lung Cancer, run by Symphony Evolution, Inc. at 4 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 non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- XL999
- Type of treatment
- Injection or infusion
- How many people
- 9 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2005to Jul 2008
- 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 NSCLC
- Prior treatment with a platinum- or taxane containing regimen
- Stage IIIB with malignant effusion, stage IV or recurrent NSCLC that is not amenable to curative therapy (either surgery or radiation therapy)
- Measurable disease according to Response Criteria for Solid Tumors (RECIST)
- ECOG performance status of 0 or 1
- Life expectancy ≥3 months
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- 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
- Use of any systemic anticancer therapy within 30 days of XL999 treatment
- More than 2 prior systemic cytotoxic chemotherapy regimens
- More than 1 prior agent targeted against VEGF or EGFR (eg, bevacizumab, erlotinib, or gefitinib)
- Subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered >30 days before study enrollment
- Uncontrolled and/or intercurrent illness
Show all 9Show fewer
- History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis
- Pregnant or breastfeeding females
- Known HIV
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Center for Oncology Research and Treatment, PA
Dallas, Texas, 75230
Joliet Oncology-Hematology Associates, Ltd.
Joliet, Illinois, 60435
Hematology-Oncology Associates of Rockland
Nyack, New York, 10960
Hematology/Oncology Associates 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 Non-Small-Cell Lung 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 non-small cell lung cancer (NSCLC). 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
- Non-small Cell Lung Cancer
- Being tested
- XL999
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XL999Drug
- The Study Treatment Period, in which subjects received a once-weekly, 4-hour intravenous (IV) infusion of XL999 at 2.4 mg/kg as outpatients for 8 weeks. Treatment was to be stopped at the occurrence of disease progression or unacceptable toxicity.
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 dyas 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: Various time points during the 8-week Study Treatment Period 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 2007
- Study completionJul 2008
Why it stopped: Study was terminated due to cardiac toxicities in the subejcts
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung 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
- 9 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
- NCT00277329
- Sponsor's protocol ID
- XL999-204
- 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 Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00277329
- Acronym / sponsor ID
- XL999-204
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to cardiac toxicities in the subejcts
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Symphony Evolution, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Jul 2008 (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 non-small cell lung cancer (NSCLC). 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 NSCLC
- Prior treatment with a platinum- or taxane containing regimen
- Stage IIIB with malignant effusion, stage IV or recurrent NSCLC that is not amenable to curative therapy (either surgery or radiation therapy)
- Measurable disease according to Response Criteria for Solid Tumors (RECIST)
- ECOG performance status of 0 or 1
Key exclusion criteria (9 listed)
- Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
- Use of any systemic anticancer therapy within 30 days of XL999 treatment
- More than 2 prior systemic cytotoxic chemotherapy regimens
- More than 1 prior agent targeted against VEGF or EGFR (eg, bevacizumab, erlotinib, or gefitinib)
- Subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered >30 days before study enrollment
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 |
|---|---|---|
| XL999• The Study Treatment Period, in which subjects received a once-weekly, 4-hour intravenous (IV) infusion of XL999 at 2.4 mg/kg as outpatients for 8 weeks. Treatment was to be stopped at the occurrence of disease progression or unacceptable toxicity. | Drug | – |
Primary outcome
Response rate
Time frame: Inclusion until disease progression
Safety and tolerability
Time frame: Inclusion until 30 dyas 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: Various time points during the 8-week Study Treatment Period 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 subejcts). 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.
Paul Woodard, MD study director
Exelixis
4 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 Non-small Cell Lung Cancer, run by Symphony Evolution, Inc. 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 9 inclusion and 9 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 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 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 subejcts). 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.