NeoplasmsPhase 1NCT00432302
Investigation of Mass Balance of the Test Drug and Major Metabolites
A Phase 1 study testing Sagopilone (BAY 86-5302, ZK 219477) in people with Neoplasms, run by Bayer at 1 site in Belgium.
Trial summary
The purpose of this study is to: a) Determine how the body takes up the test drug and distributes it into various body organs and tissues, how it processes the drug and how it ultimately removes it; and b) Examine how well the test drug works against cancer, and whether it is safe and tolerable to take Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Sagopilone (BAY 86-5302, ZK 219477)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2007to Nov 2007
- 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
- Male ≥ 18 years; female ≥ 50 years without childbearing potential (confirmed by either: age ≥ 60; or history of hysterectomy; or hormone analysis in serum: Estradiol ≤ 20 pg/mL and follicle stimulating hormone ≥ 40 IU/L)
- Solid tumor
- Adequate function of major organs
- Failed previous cancer treatment
- Peripheral venous access
Who cannot join
- Concurrent severe and/or uncontrolled disease
- Brain tumors
- Marked constipation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Mass Balance and Major Metabolites After Administration of 28 mg Radiolabeled ZK 219477 in Patients With Solid Tumor in an Open-label, Non Randomized Design
The purpose of this study is to: a) Determine how the body takes up the test drug and distributes it into various body organs and tissues, how it processes the drug and how it ultimately removes it; and b) Examine how well the test drug works against cancer, and whether it is safe and tolerable to take
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
- Conditions
- Neoplasms
- Being tested
- Sagopilone (BAY 86-5302, ZK 219477)
- Keywords
- Cancer, Tumor, Malignancy, Mass Balance, Chemotherapy, Drug, Cancer Treatment, Intravenous Infusion, Epothilone, Solid Tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sagopilone (BAY 86-5302, ZK 219477)Drug
First infusion only: 28 mg, containing 14 kBq/7.8 mcg [14C]-ZK 219477. Subsequent infusions: 16 mg/m2 ZK 219477 without radioactive label. IV infusion was given over a period of 30 min.
| Study group | Role | What they receive |
|---|---|---|
| Sagopilone | Experimental | Subjects received 28 mg ZK 219477, containing 14 kBq/7.8 µg [14C]-ZK 219477 in the first infusion (Treatment course 1) followed by subsequent infusions (Treatment courses 2 to n [till disease progression]) of 16 mg/m2 ZK 219477 without radioactive label. Interval between the treatments was at least 21 days. Receives: Drug: Sagopilone (BAY 86-5302, ZK 219477) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood, urine and fecal samples will be collected over a period of 336 hours (14 days) to measure 14C, ZK 219477 and its major metabolites following the intravenous administration of 14C-ZK 219477.
Measured: 14 days
Cmax
Maximum plasma concentration for [14C]-ZK 219477, ZK 219477
Measured: 14 days
tmax
Time to Cmax for [14C]-ZK 219477, ZK 219477
Measured: 14 days
AUC
Area under the concentration time curve for [14C]-ZK 219477, ZK 219477
Measured: 14 days
AUC(0-tlast)
AUC from administration until the last time point with measurable concentration for [14C]-ZK 219477, ZK 219477
Measured: 14 days
AUC(0-24)
AUC from time zero to 24 hours for [14C]-ZK 219477, ZK 219477
Measured: 14 days
MRT
Mean residence time for [14C]-ZK 219477, ZK 219477
Measured: 14 days
t1/2
Terminal half-life for [14C]-ZK 219477, ZK 219477
Measured: 14 days
λz
Apparent terminal rate constant for [14C]-ZK 219477, ZK 219477
Measured: 14 days
CL
Total clearance for ZK 219477
Measured: 14 days
Vss
Apparent volume of distribution at steady state for ZK 219477
Measured: 14 days
Vz
Apparent volume of distribution during terminal phase for ZK 219477
Measured: 14 days
Secondary outcomes (4)
Number of participants with adverse events
Measured: Approximately 12 weeks to 30 weeks
Overall response
Determination of complete response (CR), partial response (PR), unknown, stable disease, progressive disease (PD) by the modified Response Evaluation Criteria in Solid Tumors
Measured: Approximately 10 to 32 weeks
Best overall response
Overall response as obtained at all time points available for an individual subject combined to the 'best overall response'
Measured: Approximately 10 to 32 weeks
Responders
'Response' was considered to be established if 'Best overall response' of PR or CR was confirmed at any time after the start of study treatment. If response was established, a subject was referred to as a 'responder'
Measured: Approximately 10 to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionNov 2007
- Study completionNov 2007
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 BayerThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432302
- Sponsor's protocol ID
- 91490
- Other IDs
- 2006-000188-26, 310301
- Status last verified
- Dec 2015
- First submitted
- 6 Feb 2007
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Mass Balance and Major Metabolites After Administration of 28 mg Radiolabeled ZK 219477 in Patients With Solid Tumor in an Open-label, Non Randomized Design
- ClinicalTrials.gov ID
- NCT00432302
- Acronym / sponsor ID
- 91490
- Conditions
- Neoplasms
- Keywords
- Cancer, Tumor, Malignancy, Mass Balance, Chemotherapy, Drug, Cancer Treatment, Intravenous Infusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 7 Feb 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.
The purpose of this study is to: a) Determine how the body takes up the test drug and distributes it into various body organs and tissues, how it processes the drug and how it ultimately removes it; and b) Examine how well the test drug works against cancer, and whether it is safe and tolerable to take
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sagopilone | Experimental | Drug: Sagopilone (BAY 86-5302, ZK 219477)Subjects received 28 mg ZK 219477, containing 14 kBq/7.8 µg [14C]-ZK 219477 in the first infusion (Treatment course 1) followed by subsequent infusions (Treatment courses 2 to n [till disease progression]) of 16 mg/m2 ZK 219477 without radioactive label. Interval between the treatments was at least 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male ≥ 18 years; female ≥ 50 years without childbearing potential (confirmed by either: age ≥ 60; or history of hysterectomy; or hormone analysis in serum: Estradiol ≤ 20 pg/mL and follicle stimulating hormone ≥ 40 IU/L)
- Solid tumor
- Adequate function of major organs
- Failed previous cancer treatment
- Peripheral venous access
Key exclusion criteria (3 listed)
- Concurrent severe and/or uncontrolled disease
- Brain tumors
- Marked constipation
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 |
|---|---|---|
| Sagopilone (BAY 86-5302, ZK 219477)First infusion only: 28 mg, containing 14 kBq/7.8 mcg [14C]-ZK 219477. Subsequent infusions: 16 mg/m2 ZK 219477 without radioactive label. IV infusion was given over a period of 30 min. | Drug | Sagopilone |
Primary outcome
Blood, urine and fecal samples will be collected over a period of 336 hours (14 days) to measure 14C, ZK 219477 and its major metabolites following the intravenous administration of 14C-ZK 219477.
Time frame: 14 days
Cmax
Time frame: 14 days
Maximum plasma concentration for [14C]-ZK 219477, ZK 219477
tmax
Time frame: 14 days
Time to Cmax for [14C]-ZK 219477, ZK 219477
AUC
Time frame: 14 days
Area under the concentration time curve for [14C]-ZK 219477, ZK 219477
AUC(0-tlast)
Time frame: 14 days
AUC from administration until the last time point with measurable concentration for [14C]-ZK 219477, ZK 219477
AUC(0-24)
Time frame: 14 days
AUC from time zero to 24 hours for [14C]-ZK 219477, ZK 219477
MRT
Time frame: 14 days
Mean residence time for [14C]-ZK 219477, ZK 219477
t1/2
Time frame: 14 days
Terminal half-life for [14C]-ZK 219477, ZK 219477
λz
Time frame: 14 days
Apparent terminal rate constant for [14C]-ZK 219477, ZK 219477
CL
Time frame: 14 days
Total clearance for ZK 219477
Vss
Time frame: 14 days
Apparent volume of distribution at steady state for ZK 219477
Vz
Time frame: 14 days
Apparent volume of distribution during terminal phase for ZK 219477
4 secondary outcomes
Number of participants with adverse events
Time frame: Approximately 12 weeks to 30 weeks
Overall response
Time frame: Approximately 10 to 32 weeks
Best overall response
Time frame: Approximately 10 to 32 weeks
Responders
Time frame: Approximately 10 to 32 weeks
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 14 Dec 2015.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Bayer Study Director study director
Bayer
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 Sagopilone (BAY 86-5302, ZK 219477) in people with Neoplasms, run by Bayer at 1 site in Belgium.
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 3 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 14 Dec 2015. 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 Belgium. 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?
Blood, urine and fecal samples will be collected over a period of 336 hours (14 days) to measure 14C, ZK 219477 and its major metabolites following the intravenous administration of 14C-ZK 219477. (time frame: 14 days). The study lists 12 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 14 Dec 2015.