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Chronic Myeloid LeukemiaPhase 1NCT00464113

Study of XL228 in Subjects With Chronic Myeloid Leukemia or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia

A Phase 1 study testing XL228 in people with Chronic Myeloid Leukemia and Leukemia, Lymphoblastic, Acute, Philadelphia-Positive, run by Exelixis at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the safest dose of the BCR-ABL inhibitor XL228, how often it should be taken, and how well people with leukemia tolerate XL228. 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
49 participants
Where
6 sitesUnited States
Study dates
May 2007to Apr 2011
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 confirmed pathologic diagnosis as evidenced by the presence of the BCR-Abl translocation [t(9;22)] by fluorescence in situ hybridization (FISH), cytogenetics, or quantitative polymerase chain reaction (QPCR) of one of the following:
  • CML
  • Chronic phase (CP)
  • Accelerated phase (AP)
  • Blast phase (BP) OR
  • Ph+ ALL
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  • The subject has one of the following:
  • Known T315I Abl mutation
  • Known resistance to or intolerance of imatinib and dasatinib
  • At least one prior anti-leukemia therapy, including, but not limited to, interferon, imatinib, or dasatinib
  • The subject is at least 18 years old.
  • The subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • The subject has adequate organ function.
  • The subject is capable of understanding and complying with the protocol and has signed the informed consent document.
  • Sexually active subjects must use an accepted method of contraception during the course of the study.
  • Female subjects of childbearing potential must have a negative pregnancy test at enrollment.

Who cannot join

  • The subject has received interferon, imatinib, or dasatinib within 7 days of the first dose of XL228.
  • The subject has received an investigational agent or radiotherapy within 28 days of the first dose of XL228.
  • The subject has received immunosuppressive therapy (eg, cyclosporine, steroids, tacrolimus for graft-versus-host disease [GVHD]) within 28 days prior to the first dose of XL228.
  • The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Grade ≤1 from toxicities related to peripheral stem cell or bone marrow transplant.
  • The subject has not recovered to CTCAE v3.0 Grade ≤1 from adverse events (AEs) due to investigational drugs or other medications.
  • The subject has known allergy or hypersensitivity to any component of the investigational drug product.
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  • The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • The subject is pregnant or breastfeeding.
  • The subject is known to be positive for the human immunodeficiency virus (HIV).
  • The subject has an inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • UCLA School of Medicine

    Los Angeles, California, 90095-1678

  • University of California San Francisco

    San Francisco, California, 94143-1270

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

  • Georgetown University Medical Center, Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL228 Administered Intravenously to Subjects With Chronic Myeloid Leukemia (CML) or Philadelphia-Chromosome-Positive Acute Lymphocytic Leukemia (Ph+ ALL)

The purpose of this study is to determine the safest dose of the BCR-ABL inhibitor XL228, how often it should be taken, and how well people with leukemia tolerate XL228.

Being tested
XL228
Keywords
Myeloid Leukemia, Lymphocytic Leukemia, Ph+ ALL
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Leukemia, Lymphoid

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 groups in NCT00464113
Study groupRoleWhat they receive
1Experimentalonce-weekly dosing
Receives: Drug: XL228
2Experimentaltwice-weekly dosing
Receives: Drug: XL228

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety, tolerability, and maximum tolerated dose of once-weekly and/or twice-weekly 1-hour intravenous (IV) infusion of XL228

    Measured: Assessed at periodic visits

Secondary outcomes (2)

  1. Evaluate plasma pharmacokinetics and estimate renal elimination of once-weekly and twice-weekly 1-hour IV infusion of XL228

    Measured: Assessed at periodic visits

  2. Exploratory Outcomes: Evaluate hematologic and cytogenetic response and pharmacodynamic correlates of XL228 activity

    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.

  1. First posted20 Apr 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionDec 2010
  4. Study completionApr 2011

Why it stopped: Sponsor decision

Resources

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
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00464113
Sponsor's protocol ID
XL228-001
Status last verified
Aug 2015
First submitted
18 Apr 2007
Last updated
21 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XL228 in people with Chronic Myeloid Leukemia and Leukemia, Lymphoblastic, Acute, Philadelphia-Positive, run by Exelixis at 6 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 16 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 6 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?

Safety, tolerability, and maximum tolerated dose of once-weekly and/or twice-weekly 1-hour intravenous (IV) infusion of XL228 (time frame: Assessed at periodic visits). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00464113.

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.

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