TumorsPhase 1NCT00412789
Efficacy and Safety of Patupilone in Patients With Advanced Solid Tumors in Japan
A Phase 1 study testing Patupilone in people with Tumors, run by Novartis Pharmaceuticals at 1 site in Japan.
Trial summary
The study will evaluate the safety and efficacy of Patupilone in adult patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- Patupilone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2006to Jan 2008
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to or unsuitable for standard therapy, or for whom no standard therapy exists
- Patients with WHO Performance Status of 0-1 ( Karnofsky Performance Status of 80-100)
- At least one measurable lesion
Who cannot join
- Patients with any peripheral neuropathy
- Patients with unresolved diarrhea
- Patients with severe and/or uncontrolled medical conditions or infections that require systemic therapy
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IA, Open-label, Dose Escalation Study of Patupilone Administered Intravenously Every 3 Weeks in Adult Patients With Advanced Solid Tumors
The study will evaluate the safety and efficacy of Patupilone in adult patients with advanced solid tumors.
- Conditions
- Tumors
- Being tested
- Patupilone
- Keywords
- Advanced solid tumor, Patupilone
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatupiloneDrug
Also called EPO906
| Study group | Role | What they receive |
|---|---|---|
| EPO906 | Experimental | Not described Receives: Drug: Patupilone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity
Measured: 18 months
Secondary outcomes (3)
Safety and tolerability of patupilone assessed by CTCAE
Measured: 18 months
Pharmacokinetic profile of patupilone
Measured: 18 months
Anti-tumor activity of patupilone according to the RECIST guidelines
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412789
- Sponsor's protocol ID
- CEPO906A1103
- Status last verified
- May 2010
- First submitted
- 15 Dec 2006
- Last updated
- 31 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IA, Open-label, Dose Escalation Study of Patupilone Administered Intravenously Every 3 Weeks in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00412789
- Acronym / sponsor ID
- CEPO906A1103
- Conditions
- Tumors
- Keywords
- Advanced solid tumor, Patupilone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jan 2008 (actual)
- First posted
- 18 Dec 2006 (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.
The study will evaluate the safety and efficacy of Patupilone in adult patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPO906 | Experimental | Drug: Patupilone |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to or unsuitable for standard therapy, or for whom no standard therapy exists
- Patients with WHO Performance Status of 0-1 ( Karnofsky Performance Status of 80-100)
- At least one measurable lesion
Key exclusion criteria (4 listed)
- Patients with any peripheral neuropathy
- Patients with unresolved diarrhea
- Patients with severe and/or uncontrolled medical conditions or infections that require systemic therapy
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| PatupiloneAlso: EPO906 | Drug | EPO906 |
Primary outcome
Dose-limiting Toxicity
Time frame: 18 months
3 secondary outcomes
Safety and tolerability of patupilone assessed by CTCAE
Time frame: 18 months
Pharmacokinetic profile of patupilone
Time frame: 18 months
Anti-tumor activity of patupilone according to the RECIST guidelines
Time frame: 18 months
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 31 May 2010.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Patupilone in people with Tumors, run by Novartis Pharmaceuticals at 1 site in Japan.
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 3 inclusion and 4 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 31 May 2010. 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 Japan. 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.
What does the primary outcome measure?
Dose-limiting Toxicity (time frame: 18 months). It is what the study was designed to measure, not a finding.
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 31 May 2010.