NeoplasmsPhase 1NCT00030173
A Trial to Evaluate Epothilone D in Patients With Advanced Solid Tumors
A Phase 1 study testing Epothilone D (KOS-862) in people with Neoplasms, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic arrest by stabilizing tubulin polymerization. Since microtubules are essential for mitosis, motility, secretion and proliferation, the observed antitumor effects of epothilones have been attributed to their ability to initiate… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- Epothilone D (KOS-862)
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Jun 2003
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of histologically documented, advanced stage, primary or metastatic adult solid tumors that are refractory to standard therapy or for which no curative standard therapy exists. This includes but is not limited to cancers of the breast, ovary, head and neck, esophagus, lung, gastrointestinal tract, and sarcomas.
- Evidence of radiographically measurable or evaluable disease.
Who cannot join
- Pre-existing peripheral neuropathy of CTC Grade > 2 due to any cause.
- Documented hypersensitivity reaction (CTC Grade > 2) to prior paclitaxel or other therapy containing Cremophor.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Medical Center
Los Angeles, California, 90095-7059
About this study
Official title: A Phase 1, Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Epothilone D in Patients With Advanced Solid Tumors
Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic arrest by stabilizing tubulin polymerization. Since microtubules are essential for mitosis, motility, secretion and proliferation, the observed antitumor effects of epothilones have been attributed to their ability to initiate cell death by inhibiting such processes. Epothilone D has demonstrated in vitro cytotoxic activity in a panel of human cell lines, equipotent to that of paclitaxel. In vivo, Epothilone D has also shown significant antitumor activity in a range of xenograft models, including paclitaxel-resistant xenografts. Epothilone D is more potent than paclitaxel in cell lines that demonstrate multiple drug resistant activity overexpressing p-glycoprotein.
- Conditions
- Neoplasms
- Being tested
- Epothilone D (KOS-862)
- Keywords
- Epothilone D, tubulin polymerization
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epothilone D (KOS-862)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2002 (estimated)
- Study startOct 2001
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030173
- Sponsor's protocol ID
- KOS-101
- Status last verified
- Jan 2009
- First submitted
- 7 Feb 2002
- Last updated
- 8 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Epothilone D in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00030173
- Acronym / sponsor ID
- KOS-101
- Conditions
- Neoplasms
- Keywords
- Epothilone D, tubulin polymerization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Study completion
- Jun 2003 (actual)
- First posted
- 8 Feb 2002 (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.
Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic arrest by stabilizing tubulin polymerization. Since microtubules are essential for mitosis, motility, secretion and proliferation, the observed antitumor effects of epothilones have been attributed to their ability to initiate cell death by inhibiting such processes. Epothilone D has demonstrated in vitro cytotoxic activity in a panel of human cell lines, equipotent to that of paclitaxel. In vivo, Epothilone D has also shown significant antitumor activity in a range of xenograft models, including paclitaxel-resistant xenografts. Epothilone D is more potent than paclitaxel in cell lines that demonstrate multiple drug resistant activity overexpressing p-glycoprotein.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of histologically documented, advanced stage, primary or metastatic adult solid tumors that are refractory to standard therapy or for which no curative standard therapy exists. This includes but is not limited to cancers of the breast, ovary, head and neck, esophagus, lung, gastrointestinal tract, and sarcomas.
- Evidence of radiographically measurable or evaluable disease.
Key exclusion criteria (2 listed)
- Pre-existing peripheral neuropathy of CTC Grade > 2 due to any cause.
- Documented hypersensitivity reaction (CTC Grade > 2) to prior paclitaxel or other therapy containing Cremophor.
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 |
|---|---|---|
| Epothilone D (KOS-862) | 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 8 Jan 2009.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 Epothilone D (KOS-862) in people with Neoplasms, run by Bristol-Myers Squibb 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 2 inclusion and 2 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 8 Jan 2009. 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 8 Jan 2009.