Advanced MalignanciesPhase 1NCT00420524
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 4 sites in United States.
Trial summary
This phase I study will determine the pharmacokinetic profile of patupilone in patients with mild or moderately impaired hepatic function within 2 cycles of treatment. The study population for this trial consists of patients with a documented advanced solid tumor. 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
- 36 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2006to Jul 2010
- 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
- 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
4 sites in 1 country.
United States4 sites
Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131-5636
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
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
This phase I study will determine the pharmacokinetic profile of patupilone in patients with mild or moderately impaired hepatic function within 2 cycles of treatment. The study population for this trial consists of patients with a documented advanced solid tumor. Patients will be stratified into 3 groups: those with normal liver function, and those with mild or moderate liver dysfunction.
- 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.
To assess the effect of hepatic impairment on the pharmacokinetics of patupilone and its metabolite
Measured: After completion of the study (approximately 6 weeks from treatment)
To determine the maximum tolerated dose of patupilone in patients with hepatic impairment
Measured: After completion of the study (approximately 6 weeks from treatment)
Secondary outcomes (3)
To correlate the level of hepatic dysfunction to observed toxicity and pharmacokinetics
Measured: After completion of the study (approximately 6 weeks from treatment)
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: After completion of the study (approximately 6 weeks from treatment)
To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks
Measured: After completion of the study (approximately 6 weeks from treatment)
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 startJan 2006
- Primary completionJul 2010
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
- 36 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
- NCT00420524
- Sponsor's protocol ID
- CEPO906A2121
- Status last verified
- Dec 2011
- First submitted
- 9 Jan 2007
- Last updated
- 9 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. 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
- NCT00420524
- Acronym / sponsor ID
- CEPO906A2121
- Conditions
- Advanced Malignancies, Tumors
- Keywords
- EPO, Patupilone, Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jul 2010 (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.
This phase I study will determine the pharmacokinetic profile of patupilone in patients with mild or moderately impaired hepatic function within 2 cycles of treatment. The study population for this trial consists of patients with a documented advanced solid tumor. Patients will be stratified into 3 groups: those with normal liver function, and those with mild or moderate liver dysfunction.
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 (4 listed)
- 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
To assess the effect of hepatic impairment on the pharmacokinetics of patupilone and its metabolite
Time frame: After completion of the study (approximately 6 weeks from treatment)
To determine the maximum tolerated dose of patupilone in patients with hepatic impairment
Time frame: After completion of the study (approximately 6 weeks from treatment)
3 secondary outcomes
To correlate the level of hepatic dysfunction to observed toxicity and pharmacokinetics
Time frame: After completion of the study (approximately 6 weeks from treatment)
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: After completion of the study (approximately 6 weeks from treatment)
To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks
Time frame: After completion of the study (approximately 6 weeks from treatment)
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 9 Dec 2020.
- Results can be found for CEPO906A2121 on the Novartis Clinical Trials 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
Novartis Pharmeceuticals
4 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 4 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 4 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 9 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 4 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?
To assess the effect of hepatic impairment on the pharmacokinetics of patupilone and its metabolite (time frame: After completion of the study (approximately 6 weeks from treatment)). 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 9 Dec 2020.