Colon CancerPhase 1NCT00969046
Dose-Escalation Study in Advanced Colon Cancer Patients
A Phase 1 study testing EPO906 (patupilone) in people with Colon Cancer, run by Novartis Pharmaceuticals at 6 sites in 4 countries.
Trial summary
This study is exploring different administration schedules (short versus prolonged infusion) to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with pretreated advanced colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- EPO906 (patupilone)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Nov 2003to Nov 2006
- 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
- Histologically confirmed, locally advanced, progressive or metastatic colon cancer, up to 4 prior lines of prior chemotherapy, at least one measurable lesion according to RECIST
- Age ≥ 18 years
- Life expectancy ≥ 12 weeks
- WHO performance status of 0-1
- Negative serum pregnancy test
- Adequate hepatic or renal function and hematological parameters
Who cannot join
- Brain metastases
- Ileostomy or colonostomy
- History of pelvic radiotherapy
- Grade > 1 diarrhea at baseline
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Czechia2 sites
Novartis Investigative Site
Hradec Králové
Novartis Investigative Site
Prague
France2 sites
Novartis Investigative Site
Saint-Herblain
Novartis Investigative Site
Toulouse
About this study
Official title: EPO906 Phase I 6-arm Trial to Optimize Administration Exploring Single Dose Bolus and Continuous Infusion Over 1 or 5 Days Every 3 or 4 Weeks in Patients With Pretreated Advanced Colon Cancer With Nutritional Support Treatment and Intensive Management of Diarrhea
This study is exploring different administration schedules (short versus prolonged infusion) to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with pretreated advanced colon cancer.
- Conditions
- Colon Cancer
- Being tested
- EPO906 (patupilone)
- Keywords
- Colon cancer, MTD, DLT, EPO906, patupilone
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPO906 (patupilone)Drug
| Study group | Role | What they receive |
|---|---|---|
| Bolus | Experimental | 20 min bolus infusion Receives: Drug: EPO906 (patupilone) |
| CIV-1d | Experimental | 1 day continuous infusion Receives: Drug: EPO906 (patupilone) |
| CIV-5d | Experimental | 5 day continuous infusion Receives: Drug: EPO906 (patupilone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identifymaximum tolerated dose (MTD)
Measured: During cycle 1 and 2 (approx 6 to 8 wks)
Secondary outcomes (3)
To characterize the safety and tolerability of patupilone by assessing adverse events (AEs) and serious adverse events (SAEs), hematology and biochemistry labs, vital signs, performance status, and by physical/neurological exams
Measured: at base line, every 3 weeks prior to start of the next dose, at end of treatment
To evaluate preliminary anti-tumor activity of patupilone using standard imaging technologies (e.g. best overall response rate and time to progression according to Response Evaluation Criteria in Solid Tumors [RECIST])
Measured: at baseline and every 8 wks
To evaluate the blood concentrations profile (pharmacokinetics [PK]) of patupilone by multiple blood sampling before, during and after drug administration
Measured: Cycle 1 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startNov 2003
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Royal London Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969046
- Sponsor's protocol ID
- CEPO906A2117
- Status last verified
- Apr 2016
- First submitted
- 10 Aug 2009
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPO906 Phase I 6-arm Trial to Optimize Administration Exploring Single Dose Bolus and Continuous Infusion Over 1 or 5 Days Every 3 or 4 Weeks in Patients With Pretreated Advanced Colon Cancer With Nutritional Support Treatment and Intensive Management of Diarrhea
- ClinicalTrials.gov ID
- NCT00969046
- Acronym / sponsor ID
- CEPO906A2117
- Conditions
- Colon Cancer
- Keywords
- Colon cancer, MTD, DLT, EPO906, patupilone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 31 Aug 2009 (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.
This study is exploring different administration schedules (short versus prolonged infusion) to optimize the safety and efficacy profile of EPO906A (patupilone) in patients with pretreated advanced colon cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bolus | Experimental | Drug: EPO906 (patupilone)20 min bolus infusion |
| CIV-1d | Experimental | Drug: EPO906 (patupilone)1 day continuous infusion |
| CIV-5d | Experimental | Drug: EPO906 (patupilone)5 day continuous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed, locally advanced, progressive or metastatic colon cancer, up to 4 prior lines of prior chemotherapy, at least one measurable lesion according to RECIST
- Age ≥ 18 years
- Life expectancy ≥ 12 weeks
- WHO performance status of 0-1
- Negative serum pregnancy test
Key exclusion criteria (5 listed)
- Brain metastases
- Ileostomy or colonostomy
- History of pelvic radiotherapy
- Grade > 1 diarrhea at baseline
- 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 |
|---|---|---|
| EPO906 (patupilone) | Drug | Bolus, CIV-1d, CIV-5d |
Primary outcome
To identifymaximum tolerated dose (MTD)
Time frame: During cycle 1 and 2 (approx 6 to 8 wks)
3 secondary outcomes
To characterize the safety and tolerability of patupilone by assessing adverse events (AEs) and serious adverse events (SAEs), hematology and biochemistry labs, vital signs, performance status, and by physical/neurological exams
Time frame: at base line, every 3 weeks prior to start of the next dose, at end of treatment
To evaluate preliminary anti-tumor activity of patupilone using standard imaging technologies (e.g. best overall response rate and time to progression according to Response Evaluation Criteria in Solid Tumors [RECIST])
Time frame: at baseline and every 8 wks
To evaluate the blood concentrations profile (pharmacokinetics [PK]) of patupilone by multiple blood sampling before, during and after drug administration
Time frame: Cycle 1 and 4
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 Dec 2020.
- Results for CEPO906A2117 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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
Royal London Hospital
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EPO906 (patupilone) in people with Colon Cancer, run by Novartis Pharmaceuticals at 6 sites in 4 countries.
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 6 inclusion and 5 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 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Czechia, France, Spain, United Kingdom. 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?
To identifymaximum tolerated dose (MTD) (time frame: During cycle 1 and 2 (approx 6 to 8 wks)). 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 8 Dec 2020.