- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00104286
Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Solid Tumors
November 1, 2006 updated by: SGX Pharmaceuticals, Inc.
An Open-Label, Single-Arm, Phase I Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Subjects With an Advanced Solid Malignancy
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
50
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21231
- The Sydney Kimmel Comprehensive Cancer Center at John Hopkins
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
|
Secondary Outcome Measures
Outcome Measure |
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Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2003
Study Completion
November 1, 2005
Study Registration Dates
First Submitted
February 24, 2005
First Submitted That Met QC Criteria
February 24, 2005
First Posted (ESTIMATE)
February 25, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
November 3, 2006
Last Update Submitted That Met QC Criteria
November 1, 2006
Last Verified
November 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPD758-109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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