Study of Troxatyl™ Administered by Continuous Infusion to... | NCT00104468

Studies
Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)

NCT00104468

Sponsor

SGX Pharmaceuticals, Inc.

Status

Terminated

Last Update Posted

Jan 17, 2008Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Acute Myelogenous Leukemia

Interventions

Troxatyl™ (Cytotoxic Chemotherapeutic)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Trial stopped June 2007

Expanded Access Info

Not provided

Start Date

Apr 2003

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Feb 28, 2005

First Submission Date that Met QC Criteria

Feb 28, 2005

First Posted Date

Mar 1, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2008

Last Update Posted Date

Jan 17, 2008Estimated

Description Module

Brief Summary

This is a phase I, single-arm, open-label, multi-center study of rising doses of Troxatyl™ whose purpose is to determine the safety, tolerance, and pharmacokinetics, and to establish the recommended infusion schedule of Troxatyl™.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Troxatyl™ (Cytotoxic Chemotherapeutic)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the recommended infusion schedule for the investigational new drug administered as a continuous infusion with regards to dose limiting toxicities.

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed diagnosis of acute myelogenous leukemia (AML) refractory to prior therapy and/or unlikely to benefit from known therapies.
Subjects must have adequate organ and immune function as indicated by the following laboratory values: *Creatinine clearance ≥5 L/hr (83mL/min), *Total Bilirubin ≤2.0 mg/dL (≤34.2 µmol/L), *AST(SGOT) and ALT(SGPT) ≤3 x ULN

Exclusion Criteria:

Clinical evidence of active central nervous system (CNS) leukemic involvement
Active and uncontrolled infection
Uncontrolled medical problems unrelated to the malignancy that impair their 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 the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse.
Also not eligible are subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrollment.
Females with a positive pregnancy test at screening or subjects that have previously been enrolled into this study and subsequently withdrew.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Cornell Medical College, New York Presbyterian		New York	New York	10021	United States
MD Anderson

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12113049	Background	Giles FJ. Troxacitabine-based therapy of refractory leukemia. Expert Rev Anticancer Ther. 2002 Jun;2(3):261-6. doi: 10.1586/14737140.2.3.261.

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms