Advanced MalignanciesPhase 1NCT00421044
A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
A Phase 1 study testing Patupilone/EPO906 in people with Advanced Malignancies and Tumors, run by Novartis Pharmaceuticals at 3 sites in United States.
Trial summary
Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignancies, Tumors
- What is being tested?
- Patupilone/EPO906
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2006to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completion of the core study is required for participation in the extension.
- 18 years of age or older
- World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work.
- Life expectancy of 3 months or more
- Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist
Who cannot join
- Severe and/or uncontrolled medical disease
- Known diagnosis of human immunodeficiency virus (HIV) infection
- Presence of any other active or suspected acute or chronic uncontrolled infection
- Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease
- History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California San Diego/Moores Cancer Center
La Jolla, California, 92093-0987
Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science Center
San Antonio, Texas, 78229
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
About this study
Official title: An Open-label, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.
- Conditions
- Advanced Malignancies, Tumors
- Being tested
- Patupilone/EPO906
- Keywords
- EPO, Patupilone, Solid Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patupilone/EPO906Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Normal liver function) | Experimental | Not described Receives: Drug: Patupilone/EPO906 |
| Arm B (Mild liver dysfunction) | Experimental | Not described Receives: Drug: Patupilone/EPO906 |
| Arm C (Moderate liver dysfunction) | Experimental | Not described Receives: Drug: Patupilone/EPO906 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values
Measured: at completion of the study
To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks
Measured: at completion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startMay 2006
- Primary completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421044
- Sponsor's protocol ID
- CEPO906A2121E1
- Status last verified
- Jan 2012
- First submitted
- 9 Jan 2007
- Last updated
- 11 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function
- ClinicalTrials.gov ID
- NCT00421044
- Acronym / sponsor ID
- CEPO906A2121E1
- Conditions
- Advanced Malignancies, Tumors
- Keywords
- EPO, Patupilone, Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Feb 2008 (actual)
- First posted
- 11 Jan 2007 (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.
Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (Normal liver function) | Experimental | Drug: Patupilone/EPO906 |
| Arm B (Mild liver dysfunction) | Experimental | Drug: Patupilone/EPO906 |
| Arm C (Moderate liver dysfunction) | Experimental | Drug: Patupilone/EPO906 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completion of the core study is required for participation in the extension.
- 18 years of age or older
- World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work.
- Life expectancy of 3 months or more
- Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist
Key exclusion criteria (6 listed)
- Severe and/or uncontrolled medical disease
- Known diagnosis of human immunodeficiency virus (HIV) infection
- Presence of any other active or suspected acute or chronic uncontrolled infection
- Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease
- History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ
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 |
|---|---|---|
| Patupilone/EPO906 | Drug | Arm A (Normal liver function), Arm B (Mild liver dysfunction), Arm C (Moderate liver dysfunction) |
Primary outcome
Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values
Time frame: at completion of the study
To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks
Time frame: at completion of the study
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 11 Jan 2012.
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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 Pharmeceuticals
3 sites 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/EPO906 in people with Advanced Malignancies and Tumors, run by Novartis Pharmaceuticals at 3 sites 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 6 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 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does the primary outcome measure?
Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values (time frame: at completion of the study). The study lists 2 primary outcomes in all. 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 11 Jan 2012.