Acute Myeloid LeukemiaPhase 2NCT00322673
Study of XL999 in Patients With Acute Myeloid Leukemia (AML)
A Phase 2 study testing XL999 in people with Acute Myeloid Leukemia and AML, run by Symphony Evolution, Inc. at 7 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 relapsed or newly-diagnosed AML. XL999 is a small molecule inhibitor against Flk1/kinase insert domain receptor (KDR), PDGFR, c-Kit, FLT3 and SRC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, AML
- What is being tested?
- XL999
- Type of treatment
- Injection or infusion
- How many people
- 14 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2006to May 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
- Diagnosis of acute myeloid leukemia (except AML FAB-M3 or acute promyelocytic leukemia [APL]) based on the World Health Organization (WHO) classification of ≥ 20% blasts in the bone marrow or peripheral blood at initial diagnosis (prior to start of standard chemotherapy)
- ECOG performance status of 0 or 1
- Subjects with newly-diagnosed AML or subjects with relapsed AML after at least 2 chemotherapy regimens.
- Adequate liver and renal function
- Signed informed consent
Who cannot join
- Anticancer therapy including chemotherapeutic, biologic, or investigative agents within 30 days of XL999 treatment
- Hematopoietic stem cell transplantation within the previous 6 weeks
- Immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus) for graft-versus-host disease (GvHD) within 30 days prior to the start of XL999
- The subject has not recovered to grade ≤ 1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs or stem cell transplantation which were administered > 4 weeks prior to study enrollment
- Uncontrolled and/or concomitant illness
- Pregnant or breastfeeding females
- Known HIV
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Eddie Hu
Alhambra, California, 91801
Northwestern University Feinberg School of Medicine, Division of Hematology/Oncology
Chicago, Illinois, 60611
American Health Network of Indiana
Indianapolis, Indiana, 46202
Section of Hematology/Oncology Indiana Cancer Pavilion
Indianapolis, Indiana, 46202
Ronald Paquette
Los Angeles, California, 90095
The Thomas and Dorothy Leavey Cancer Center
Northridge, California, 91328
David Chan
Redondo Beach, California, 90277
About this study
Official title: A Phase 2 Study of XL999 Administered Intravenously to Subjects With Acute Myeloid Leukemia
This clinical study is being conducted at multiple sites to determine the activity, safety and tolerability of XL999 when given weekly to patients with relapsed or newly-diagnosed AML. XL999 is a small molecule inhibitor against Flk1/kinase insert domain receptor (KDR), PDGFR, c-Kit, FLT3 and SRC. c-Kit and FLT3 are receptors commonly expressed on AML blasts.
- Conditions
- Acute Myeloid Leukemia, AML
- Being tested
- XL999
- Keywords
- acute myeloid leukemia, AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XL999Drug
XL999 was administered at a dose of 2.4 mg/kg given as a 4-hour IV infusion weekly for 4 weeks. In the absence of progressive disease and unacceptable toxicity, subjects were to receive XL999 treatment weekly for up to 1 year on this study
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic and cytogenetic response rate
Measured: Inclusion until disease progression
Safety and tolerability
Measured: Inclusion until 30 dyas post last treatment
Secondary outcomes (3)
Duration of hematologic response and transfusion independence
Measured: Inclusion until disease progression
Progression-free survival
Measured: Inclusion until disease progression
Overall survival
Measured: Inclusion until 180-day Follow-up post last treatment or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2006 (estimated)
- Study startMay 2006
- Primary completionNov 2006
- Study completionMay 2007
Why it stopped: Study was terminated due to cardiac toxicities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- 14 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
- NCT00322673
- Sponsor's protocol ID
- XL999-207
- Status last verified
- Feb 2010
- First submitted
- 4 May 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 Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00322673
- Acronym / sponsor ID
- XL999-207
- Conditions
- Acute Myeloid Leukemia, AML
- Keywords
- acute myeloid leukemia, AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to cardiac toxicities
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Symphony Evolution, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 8 May 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 relapsed or newly-diagnosed AML. XL999 is a small molecule inhibitor against Flk1/kinase insert domain receptor (KDR), PDGFR, c-Kit, FLT3 and SRC. c-Kit and FLT3 are receptors commonly expressed on AML blasts.
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 (5 listed)
- Diagnosis of acute myeloid leukemia (except AML FAB-M3 or acute promyelocytic leukemia [APL]) based on the World Health Organization (WHO) classification of ≥ 20% blasts in the bone marrow or peripheral blood at initial diagnosis (prior to start of standard chemotherapy)
- ECOG performance status of 0 or 1
- Subjects with newly-diagnosed AML or subjects with relapsed AML after at least 2 chemotherapy regimens.
- Adequate liver and renal function
- Signed informed consent
Key exclusion criteria (7 listed)
- Anticancer therapy including chemotherapeutic, biologic, or investigative agents within 30 days of XL999 treatment
- Hematopoietic stem cell transplantation within the previous 6 weeks
- Immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus) for graft-versus-host disease (GvHD) within 30 days prior to the start of XL999
- The subject has not recovered to grade ≤ 1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs or stem cell transplantation which were administered > 4 weeks prior to study enrollment
- Uncontrolled and/or concomitant 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 was administered at a dose of 2.4 mg/kg given as a 4-hour IV infusion weekly for 4 weeks. In the absence of progressive disease and unacceptable toxicity, subjects were to receive XL999 treatment weekly for up to 1 year on this study | Drug | – |
Primary outcome
Hematologic and cytogenetic response rate
Time frame: Inclusion until disease progression
Safety and tolerability
Time frame: Inclusion until 30 dyas post last treatment
3 secondary outcomes
Duration of hematologic response and transfusion independence
Time frame: Inclusion until disease progression
Progression-free survival
Time frame: Inclusion until disease progression
Overall survival
Time frame: Inclusion until 180-day Follow-up post last treatment or death
Results and safety
The study was stopped early (reason given: Study was terminated due to cardiac toxicities). 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
7 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 Acute Myeloid Leukemia and AML, run by Symphony Evolution, Inc. at 7 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 5 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 7 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). 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?
Hematologic and cytogenetic 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.