Neoplasm MalignantPhase 1NCT01527929
Pharmacokinetics and Safety Study of Cabazitaxel in Cancer Patients With Renal Impairment
A Phase 1 study testing Cabazitaxel XRP6258 in people with Neoplasm Malignant, run by Sanofi at 7 sites in 5 countries.
Trial summary
Primary Objective: To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel Secondary Objective: To assess the safety of cabazitaxel in patients with various degrees of renal impairment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Malignant
- What is being tested?
- Cabazitaxel XRP6258
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Apr 2012to Nov 2013
- 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
- Diagnosis of histologically or cytologically proven non-hematologic malignancy. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists. Cabazitaxel is an adequate treatment option, as judged by investigator.
- Eastern Cooperative Oncology Group performance status 0 - 2
- Stable renal function
- Patients must have adequate liver and marrow function as defined below:
- Absolute neutrophil count ≥ 1.5x10^9/L
- Platelets ≥ 100x10^9/L
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- Total bilirubin ≤ 1.0 x the institutions upper limit of normal
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x the institutions upper limit of normal
- Alkaline phosphatase ≤ 2.5 x the institutions upper limit of normal
- Patient may have a Grade 1 or less neurotoxicity at study entry.
- Life expectancy > 3 months
- Age ≥ 18 years old
- If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.
- Having given written informed consent prior to any procedure related to the study
Who cannot join
- Less than 4 weeks have elapsed from prior anticancer therapy (surgery, chemotherapy, radiation therapy, hormonal therapy and immunotherapy). Prior isotope therapy and radiotherapy to ≥ 30% of bone marrow are not allowed.
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, class III or IV congestive heart failure, stroke or transient ischemic attack.
- Any of the following within 3 months prior to study start: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
- Active hepatitis
- Acute renal failure (new or superimposed to pre-existing chronic renal impairment), nephrotic syndrome.
- Patients requiring dialysis during the study.
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- History of hypersensitivity to docetaxel or polysorbate 80.
- Known acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral treatment.
- Known brain metastases.
- If female, pregnancy or breast-feeding.
- Any treatment known to induce CYP isoenzymes (e.g., phenobarbital, phenytoin, carbamazepine, rifampicin, St John's Wort) or to strongly inhibit CYP3A4 activities (e.g., ketoconazole, itraconazole, macrolides, antiprotease agents, etc) is not allowed within 2 weeks before or during the test period of the pharmacokinetic sampling
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Belgium2 sites
Investigational Site Number 056002
Brussels, 1200
Investigational Site Number 056001
Ghent, 9000
Netherlands2 sites
Investigational Site Number 528001
Rotterdam, 3075 EA
Investigational Site Number 528002
Utrecht, 3584 CX
United Kingdom1 site
Investigational Site Number 826001
Cambridge, CB2 2QQ
About this study
Official title: An Open-label Pharmacokinetic and Safety Study of Cabazitaxel in Patients With Solid Tumors With Moderately and Severely Impaired and With Normal Renal Function
Primary Objective:
- To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel
Secondary Objective:
- To assess the safety of cabazitaxel in patients with various degrees of renal impairment
Read the detailed description
The study consists of a screening phase, registration, cabazitaxel administration will start within 5 business days of registration, with 21-day study treatment cycles. Cycle lengths may be extended up to a maximum of 14 additional days in case of unresolved toxicity. Patients continue to receive treatment until they experience, unacceptable toxicities/Adverse Events, disease progression, withdraw their consent, or the investigator decides to discontinue the patient, and the subsequent 30 days follow-up or study cut-off, whichever comes first.
Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.
- Conditions
- Neoplasm Malignant
- Being tested
- Cabazitaxel XRP6258
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabazitaxel XRP6258Drug
Pharmaceutical form: solution for infusion Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Normal renal function - Cabazitaxel administered once every 3 weeks Receives: Drug: Cabazitaxel XRP6258 |
| Cohort B | Experimental | Moderate renal dysfunction - Cabazitaxel administered once every 3 weeks Receives: Drug: Cabazitaxel XRP6258 |
| Cohort C | Experimental | Severe renal dysfunction - Cabazitaxel administered once every 3 weeks Receives: Drug: Cabazitaxel XRP6258 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile of cabazitaxel in study population
Measured: Up to day 10
Secondary outcomes (1)
Safety profile of cabazitaxel in study population, as measured by adverse events, clinical, laboratory and ECG parameters
Measured: up to 30 days after the last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527929
- Sponsor's protocol ID
- POP12251
- Other IDs
- 2011-001517-14, U1111-1121-4512
- Status last verified
- Dec 2013
- First submitted
- 2 Feb 2012
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pharmacokinetic and Safety Study of Cabazitaxel in Patients With Solid Tumors With Moderately and Severely Impaired and With Normal Renal Function
- ClinicalTrials.gov ID
- NCT01527929
- Acronym / sponsor ID
- POP12251
- Conditions
- Neoplasm Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 7 Feb 2012 (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.
Primary Objective:
- To assess potential impact of moderate and severe renal impairment on the pharmacokinetics of cabazitaxel
Secondary Objective:
- To assess the safety of cabazitaxel in patients with various degrees of renal impairment
Detailed description
The study consists of a screening phase, registration, cabazitaxel administration will start within 5 business days of registration, with 21-day study treatment cycles. Cycle lengths may be extended up to a maximum of 14 additional days in case of unresolved toxicity. Patients continue to receive treatment until they experience, unacceptable toxicities/Adverse Events, disease progression, withdraw their consent, or the investigator decides to discontinue the patient, and the subsequent 30 days follow-up or study cut-off, whichever comes first.
Patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawn criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Cabazitaxel XRP6258Normal renal function - Cabazitaxel administered once every 3 weeks |
| Cohort B | Experimental | Drug: Cabazitaxel XRP6258Moderate renal dysfunction - Cabazitaxel administered once every 3 weeks |
| Cohort C | Experimental | Drug: Cabazitaxel XRP6258Severe renal dysfunction - Cabazitaxel administered once every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosis of histologically or cytologically proven non-hematologic malignancy. The cancer must be one that is either refractory to standard therapy or for which no standard therapy exists. Cabazitaxel is an adequate treatment option, as judged by investigator.
- Eastern Cooperative Oncology Group performance status 0 - 2
- Stable renal function
- Patients must have adequate liver and marrow function as defined below:
- Patient may have a Grade 1 or less neurotoxicity at study entry.
Key exclusion criteria (12 listed)
- Less than 4 weeks have elapsed from prior anticancer therapy (surgery, chemotherapy, radiation therapy, hormonal therapy and immunotherapy). Prior isotope therapy and radiotherapy to ≥ 30% of bone marrow are not allowed.
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, class III or IV congestive heart failure, stroke or transient ischemic attack.
- Any of the following within 3 months prior to study start: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
- Active hepatitis
- Acute renal failure (new or superimposed to pre-existing chronic renal impairment), nephrotic syndrome.
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 |
|---|---|---|
| Cabazitaxel XRP6258Pharmaceutical form: solution for infusion Route of administration: intravenous | Drug | Cohort A, Cohort B, Cohort C |
Primary outcome
Pharmacokinetic profile of cabazitaxel in study population
Time frame: Up to day 10
1 secondary outcome
Safety profile of cabazitaxel in study population, as measured by adverse events, clinical, laboratory and ECG parameters
Time frame: up to 30 days after the last dosing
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 4 Dec 2013.
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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.
Clinical Sciences & Operations study director
Sanofi
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cabazitaxel XRP6258 in people with Neoplasm Malignant, run by Sanofi at 7 sites in 5 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 14 inclusion and 12 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 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, Netherlands, Italy, 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?
Pharmacokinetic profile of cabazitaxel in study population (time frame: Up to day 10). 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 4 Dec 2013.