Sarcoma, KaposiPhase 1NCT00002342
A Study of Tecogalan Sodium
A Phase 1 study testing Tecogalan sodium in people with Sarcoma, Kaposi and HIV Infections, run by Daiichi Pharmaceuticals at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Kaposi, HIV Infections
- What is being tested?
- Tecogalan sodium
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021
About this study
Official title: A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Twice Weekly for 21 Days
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.
Read the detailed description
Patients receive intravenous DS-4152 by infusion twice weekly for 21 days, 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.
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Being tested
- Tecogalan sodium
- Keywords
- Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, tecogalan
- Medical subject headings
- Sarcoma, Kaposi, HIV Infections, Neoplasms, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecogalan sodiumDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoma, KaposiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Daiichi Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002342
- Sponsor's protocol ID
- 088C
- Other IDs
- 4152A-PRT004
- Status last verified
- Apr 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Tecogalan Sodium (DS-4152) Administered as an Infusion Twice Weekly for 21 Days
- ClinicalTrials.gov ID
- NCT00002342
- Acronym / sponsor ID
- 088C
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Keywords
- Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Antineoplastic Agents, tecogalan
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Daiichi PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients receive intravenous DS-4152 by infusion twice weekly for 21 days, 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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tecogalan sodium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tecogalan sodium in people with Sarcoma, Kaposi and HIV Infections, run by Daiichi Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.