Search / Trial NCT00002137

A Phase I Trial of Tecogalan Sodium ( DS-4152 ) Administered as an Infusion Weekly x 4

Launched by DAIICHI PHARMACEUTICALS · Aug 30, 2001

Trial Information

Current as of December 06, 2024

Completed

Keywords

Neoplasms Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Antineoplastic Agents Tecogalan

ClinConnect Summary

Patients receive intravenous DS-4152 by infusion weekly for 4 weeks, followed by 2 weeks of rest; courses may repeat. Patients undergo weekly follow-up. A punch biopsy will be obtained from patients with Kaposi's sarcoma.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • Kaposi's sarcoma plus HIV infection OR metastatic solid tumor.
  • Life expectancy of at least 12 weeks.
  • NO symptomatic AIDS-defining opportunistic infection within the past 4 weeks.
  • Recovered from toxicity of any prior anticancer therapy.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Leukemia or lymphoma.
  • Current gastrointestinal bleeding by stool guaiac.
  • Extensive bone metastases or significant radiographic osteoporosis in patients with solid tumors.
  • Active heart disease such as uncontrolled angina, uncompensated congestive heart failure, or dysrhythmias requiring antiarrhythmics.
  • Acute intercurrent infection other than genital herpes.
  • Symptomatic or known central nervous system involvement (including brain metastases) unless stable and off therapy.
  • Concurrent Medication:
  • Excluded:
  • Other anticancer therapy.
  • Other investigational agents.
  • Patients with the following prior conditions are excluded:
  • History of acute or chronic gastrointestinal bleeding or inflammatory bowel disease.
  • History of myocardial infarction within past 6 months.
  • Prior Medication:
  • Excluded:
  • Anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C).
  • Investigational agents within the past 4 weeks.

About Daiichi Pharmaceuticals

Daiichi Pharmaceuticals is a global biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapies that address unmet medical needs. With a strong emphasis on advancing healthcare through cutting-edge science and technology, the company focuses on a diverse range of therapeutic areas, including oncology, cardiovascular, and metabolic diseases. Committed to improving patient outcomes, Daiichi Pharmaceuticals leverages its extensive expertise and collaborative partnerships to drive clinical trials that explore novel treatment options and enhance the quality of life for patients worldwide.

Locations

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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