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

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Daiichi Sankyo

Status and phase

Completed
Phase 1

Conditions

Sarcoma, Kaposi
HIV Infections

Treatments

Drug: Tecogalan sodium

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002137
4152A-PRT002
088B

Details and patient eligibility

About

To evaluate the safety of different doses and dosing regimens of tecogalan sodium (DS-4152) and to establish the MTD at each of the different dosing schedules.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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