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Leukemia, Myeloid, AcutePhase 2NCT00129948

Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

A Phase 2 study testing Troxatyl™ (troxacitabine) in people with Leukemia, Myeloid, Acute, run by SGX Pharmaceuticals, Inc. at 20 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

This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
Troxatyl™ (troxacitabine)
How many people
211 participants
Where
20 sitesUnited States
Study dates
Jul 2005to Oct 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

  • Confirmed diagnosis of acute myeloid leukemia (AML) in the second salvage setting: refractory to two prior courses of therapy or primary refractory without response to two previous courses of leukemia therapy.
  • Patients must have received at least two previous courses of induction chemotherapy to be considered in the second salvage setting.
  • Patients who are in second relapse, must have had a duration of their second CR or CRp of less than six months.
  • Subjects must have adequate organ and immune function as indicated by the following laboratory values:
  • Creatinine clearance ≥ 45 mL/min and ≤ 125 mL/min;
  • Total bilirubin ≤ 2.0 mg/dL (≤ 34.2 µmol/L);
  • AST (SGOT) and ALT (SGPT) ≤ 3 x upper limit of normal (ULN).
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of < 2, and an estimated life expectancy of at least eight weeks.

Who cannot join

  • Clinical evidence of active central nervous system (CNS) leukemic involvement
  • Active and uncontrolled infection
  • Uncontrolled medical problems unrelated to the malignancy that impair patient ability to give informed consent or unacceptably reduce the safety of the proposed treatment
  • Neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
  • Known or suspected intolerance or hypersensitivity to Troxatyl® or closely related compounds such as lamivudine or any of the stated ingredients
  • A recent history of alcohol or other substance abuse
Show all 9Show fewer
  • Subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrolment
  • Females with a positive pregnancy test at screening
  • Subjects who have previously been enrolled into this study and subsequently withdrew

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Winship Cancer Institute, Emory University Hosp.

    Atlanta, Georgia, 30322

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Univ. of South Carolina, Hematology/Oncology Division

    Charleston, South Carolina, 29425

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Harper Hospital - Karmanos Cancer Center

    Detroit, Michigan, 48201

  • Univ. of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

  • Univ. of Florida, Baptist Cancer Center

    Jacksonville, Florida, 32209

  • Scripps Clinic

    La Jolla, California, 92037

  • USC-Norris Neuro-Oncology Program

    Los Angeles, California, 90033

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Univ. of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

  • Morgantown Internal Medicine Group

    Morgantown, West Virginia, 26505

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Presbyterian Hospital-Cornell Campus

    New York, New York, 10021

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • UCSD Moores Cancer Center

    San Diego, California, 92093

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Wake Forest Univ. School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: An Open-Label, Single-Arm, Multi-Center, Phase II Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Patients With Acute Myeloid Leukemia (AML) in Second Salvage

This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML.

Read the detailed description

This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML. The study will primarily assess the complete response (CR) rate of a 5-day continuous infusion of troxacitabine at 12 mg/m2/day given as second salvage therapy in adult patients with AML, with secondary objectives to determine the overall, relapse-free and event-free survival and remission duration; to determine the duration of response; to determine the complete response with incomplete platelet recovery (CRp) rate; to evaluate the tolerability and safety of 5-day continuous intravenous (IV) infusion of troxacitabine; and to determine the relationship between troxacitabine plasma concentrations, anti-leukemic activity and adverse events. Additional cycles of treatment may be given at the investigator's discretion, provided that the subject does not have progressive disease or experience a dose limiting toxicity. Bone marrow transplantation in responding subjects will be allowed.

Being tested
Troxatyl™ (troxacitabine)
Keywords
Acute myeloid leukemia, AML, refractory, relapsed
Medical subject headings
Leukemia, Myeloid, Acute, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Troxatyl™ (troxacitabine)Drug

What is being measured

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

  1. To determine complete response (CR) rate

Secondary outcomes (2)

  1. To determine the complete response with incomplete platelet recovery (CRp) rate, and recurrent disease (RD) rates

  2. Efficacy and safety, preliminary evidence of the anti-tumor activity, determination of Troxatyl™ infusion pharmacokinetic parameters

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2005 (estimated)
  2. Study startJul 2005
  3. Study completionOct 2007

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
211 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00129948
Sponsor's protocol ID
SPD758-216
Status last verified
Nov 2006
First submitted
10 Aug 2005
Last updated
3 Nov 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Troxatyl™ (troxacitabine) in people with Leukemia, Myeloid, Acute, run by SGX Pharmaceuticals, Inc. at 20 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 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 3 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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. 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 determine complete response (CR) rate. 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 NCT00129948.

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 3 Nov 2006.

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