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
  Purpose

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.


Condition Intervention Phase
Neoplasms
Drug: Troxatyl™ (Cytotoxic Chemotherapeutic)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm, Phase I Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Subjects With an Advanced Solid Malignancy

Resource links provided by NLM:


Further study details as provided by SGX Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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:
  • Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity.

Estimated Enrollment: 50
Study Start Date: January 2003
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104286

Locations
United States, Maryland
The Sydney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
SGX Pharmaceuticals, Inc.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00104286     History of Changes
Other Study ID Numbers: SPD758-109
Study First Received: February 24, 2005
Last Updated: November 1, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Troxacitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 26, 2014