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An Open-Label, Single-Arm, Phase I Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Subjects With an Advanced Solid Malignancy

Phase 1/Phase 2
18 Years
Not Enrolling

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Trial Information

An Open-Label, Single-Arm, Phase I Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Subjects With an Advanced Solid Malignancy

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.


United States: Food and Drug Administration

Study ID:




Start Date:

January 2003

Completion Date:

November 2005

Related Keywords:

  • Neoplasms
  • Neoplasms



The Sydney Kimmel Comprehensive Cancer Center at John Hopkins Baltimore, Maryland  21231