Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Solid Tumors

This study has been terminated.

Sponsor:

Information provided by:

SGX Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00104286

First received: February 24, 2005

Last updated: November 1, 2006

Last verified: November 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	February 24, 2005
Last Updated Date	November 1, 2006
Start Date ^ICMJE	January 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	To determine the recommended infusion schedule for the investigational new drug administered as a continuous infusion, and to define the safety tolerance and dose limiting toxicities.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00104286 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Solid Tumors
Official Title ^ICMJE	An Open-Label, Single-Arm, Phase I Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Subjects With an Advanced Solid Malignancy
Brief Summary	This is a phase I, single-arm, open-label, single-center study to establish the recommended infusion schedule for Troxatyl™ administered as a continuous infusion for 2-5 days to subjects with solid tumors.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Neoplasms
Intervention ^ICMJE	Drug: Troxatyl™ (Cytotoxic Chemotherapeutic)
Study Arm (s)
Publications *	Giles FJ. Troxacitabine-based therapy of refractory leukemia. Expert Rev Anticancer Ther. 2002 Jun;2(3):261-6. Review.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	50
Completion Date	November 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnosis of advanced solid malignancy refractory to prior therapy and unlikely to benefit from known therapies (e.g., chemotherapy, radiation therapy, and surgery). Diagnosis confirmed histologically or cytologically. Subjects may have received prior cancer therapy (including surgery, radiotherapy, chemotherapy, and hormonal therapy), but must have completed all therapies at least 30 days prior to study drug administration (42 days for nitrosourea or mitomycin). Subjects must have recovered from the toxic effects associated with prior treatment. Subjects must have an Eastern Cooperative Oncology Group performance status of ≤ 2 and an estimated life expectancy of at least 12 weeks. Subjects must have adequate organ and immune function as indicated by standard laboratory tests. The subject must understand, be able, willing, and likely to fully comply with study procedures, including scheduled follow-up, and restrictions. The subject must give written, personally signed and dated, informed consent to participate in the study before implementing any study related procedures. Exclusion Criteria: Previously documented brain metastases. Active and uncontrolled infection. Subjects with uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment. Neurological or psychiatric disorders that would interfere with consent or study follow-up. Prior treatment with more than 6 courses of alkylating agent-containing chemotherapy (except low-dose cisplatin) or more than 4 courses of carboplatin, radiation therapy to > 25% of hematopoietic reserves or two or more courses of mitomycin C or nitrosourea. Known or suspected intolerance or hypersensitivity to the study materials [or closely related compounds] or any of their stated ingredients. History of alcohol or other substance abuse within the last year. Use of another investigational agent or participation in a clinical trial within 30 days prior to enrollment. Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening must be excluded. Subjects that have previously been enrolled into this study and subsequently withdrawn must also be excluded.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00104286
Other Study ID Numbers ^ICMJE	SPD758-109
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	SGX Pharmaceuticals, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	SGX Pharmaceuticals, Inc.
Verification Date	November 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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