Advanced MalignanciesPhase 1NCT00955084
Maintenance Study on the Long Term Safety of XL999
A Phase 1 study testing XL999 in people with Advanced Malignancies, run by Symphony Evolution, Inc. at 2 sites in United States.
Trial summary
The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999. The secondary objectives of this study are as follows: To evaluate tumor response after long term repeat administration of XL999 in two subjects rolled over from other XL999… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- XL999
- Type of treatment
- Injection or infusion
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to May 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 is currently enrolled in Protocols XL999-001 or XL999-204
- The subject has received XL999 for at least one year prior to enrollment
- Per the respective parent XL999 protocol, the subject is eligible to continue to receive XL999 in the absence of progressive disease (PD) or unacceptable drug-related toxicity
Who cannot join
- Progressive disease
- Any development(s) that would meet the exclusion criteria from the subject's respective XL999 protocol (XL999-001 or XL999-204)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hematology Oncology Associates of Rockland Union State Bank Cancer Center
Nyack, New York, 10960
University of Texas Cancer Center
San Antonio, Texas, 78229
About this study
Official title: A Maintenance Study Evaluating the Long Term Safety of XL999 Administered Intravenously to Subjects With Advanced Malignancies Previously Enrolled in Other XL999 Studies
The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999.
The secondary objectives of this study are as follows:
- To evaluate tumor response after long term repeat administration of XL999 in two subjects rolled over from other XL999 studies.
- To characterize the long term safety and tolerability of XL999 after repeat administration in two subjects rolled over from other XL999 studies.
- To characterize the long term effects of XL999 on cardiac function after repeat administration in two subjects rolled over from other XL999 studies.
- Conditions
- Advanced Malignancies
- Being tested
- XL999
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XL999Drug
XL999 for injection will be supplied as a brown, sterile injectable solution at a concentration of 5 mg/mL
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999.
Measured: Progressive disease or end of study
Secondary outcomes (1)
Evaluate tumor response after long term repeat administration of XL999 Characterize long term safety and tolerability of XL999 after repeat administration Characterize long term effects of XL999 on cardiac function after repeat administration
Measured: Progressive disease or end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startAug 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symphony Evolution, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charles W. Finn, PhD, Study director, Symphony Evolution, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955084
- Sponsor's protocol ID
- XL999-900
- Status last verified
- Sep 2010
- First submitted
- 5 Aug 2009
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Maintenance Study Evaluating the Long Term Safety of XL999 Administered Intravenously to Subjects With Advanced Malignancies Previously Enrolled in Other XL999 Studies
- ClinicalTrials.gov ID
- NCT00955084
- Acronym / sponsor ID
- XL999-900
- Conditions
- Advanced Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Symphony Evolution, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Aug 2009 (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 primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999.
The secondary objectives of this study are as follows:
- To evaluate tumor response after long term repeat administration of XL999 in two subjects rolled over from other XL999 studies.
- To characterize the long term safety and tolerability of XL999 after repeat administration in two subjects rolled over from other XL999 studies.
- To characterize the long term effects of XL999 on cardiac function after repeat administration in two subjects rolled over from other XL999 studies.
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 (3 listed)
- The subject is currently enrolled in Protocols XL999-001 or XL999-204
- The subject has received XL999 for at least one year prior to enrollment
- Per the respective parent XL999 protocol, the subject is eligible to continue to receive XL999 in the absence of progressive disease (PD) or unacceptable drug-related toxicity
Key exclusion criteria (2 listed)
- Progressive disease
- Any development(s) that would meet the exclusion criteria from the subject's respective XL999 protocol (XL999-001 or XL999-204)
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 for injection will be supplied as a brown, sterile injectable solution at a concentration of 5 mg/mL | Drug | – |
Primary outcome
The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999.
Time frame: Progressive disease or end of study
1 secondary outcome
Evaluate tumor response after long term repeat administration of XL999 Characterize long term safety and tolerability of XL999 after repeat administration Characterize long term effects of XL999 on cardiac function after repeat administration
Time frame: Progressive disease or end of study
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 24 Sep 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.
Charles W. Finn, PhD study director
Symphony Evolution, Inc.
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 Advanced Malignancies, 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 3 inclusion and 2 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 24 Sep 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?
The primary objective of this study is to allow rollover of the two remaining subjects from the other XL999 studies to continue to receive XL999. (time frame: Progressive disease or end of study). 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 24 Sep 2010.