Solid CancerPhase 1NCT00925743
A Study to Evaluate the Effects of Combining Cabazitaxel With Cisplatin Given Every 3 Weeks in Patients With Advanced Solid Cancer
A Phase 1 study testing cabazitaxel (XRP6258) in people with Solid Cancer, run by Sanofi at 7 sites in United States.
Trial summary
This study is designed as a phase 1, multicenter, open-label, single arm, dose-escalation, study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics (PK), and efficacy in solid tumors (parts 1 and 2) and single sequence, two-treatment, crossover studies to determine the effect of strong… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancer
- 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
- 76 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2009to Mar 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
- confirmed metastatic or unremovable advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, but for which cisplatin based therapy is appropriate
- signed informed consent
Who cannot join
- limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale)
- inability to follow study requirements and schedule
- treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other cancer therapy
- serious medical illness at same time of study and/or significantly abnormal lab reports
- lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding.
- Women of childbearing potential not protected by highly effective contraceptive method of birth control OTHER than hormonal contraception (Part 4 only).
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- prior significant hearing or kidney problems
- continued toxic effects of prior chemotherapy
- cancers that cannot be physically measured (Part 2 only)
- 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 1 country.
7 sites in 1 country
United States7 sites
Investigational Site Number 840002
Baltimore, Maryland, 21201
Investigational Site Number 840007
Cincinnati, Ohio, 45267-0542
Investigational Site Number 840010
Decatur, Illinois, 62526
Investigational Site Number 840008
Los Angeles, California, 90048
Investigational Site Number 840005
San Antonio, Texas, 78229
Investigational Site Number 840003
San Diego, California, 92123
Investigational Site Number 840006
St Louis, Missouri, 63110
About this study
Official title: A Dose-Escalation Study Of The Safety, Tolerability, And Pharmacokinetics Of Cabazitaxel In Combination With Cisplatin Administered Every 3 Weeks In Subjects With Advanced Solid Malignancies
This study is designed as a phase 1, multicenter, open-label, single arm, dose-escalation, study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics (PK), and efficacy in solid tumors (parts 1 and 2) and single sequence, two-treatment, crossover studies to determine the effect of strong CYP3A4 inhibition and induction on the PK of Cabazitaxel in patients with solid tumors (part 3 and part 4, respectively).
There are 4 parts to the study:
Read more
Part 1: Determine the Dose Limiting Toxicities (DLT)'s and Maximum Tolerated Dose (MTD) based on safety.
Part 2: Determine the anti-tumor activity of the combination regimen at the Maximum Tolerated Dose (MTD) in an extended cohort of patients.
Part 3: Determine the effect of a strong CYP3A4 inhibitor (ketoconazole) on the pharmacokinetic (PK) of Cabazitaxel.
Part 4: Determine the effect of a strong CYP3A4 inducer (rifampin) on the pharmacokinetic (PK) of Cabazitaxel.
Read the detailed description
The total duration on the study per subject will be about 26 weeks broken down as follows:
- A maximum of 21-day screening phase,
- 21-days (+/- 2 weeks) study treatment cycles,
- 30-day follow-up visit after the last dose of study medication.
- Cut-off date for parts 1, 2, 3 and 4: when the last patient has completed 6 cycles (parts 1 and 2) or 2 cycles (parts 3 and 4) of treatment or discontinued study treatment (for disease progression, unacceptable toxicity, withdrawal of consent, or investigator's decision to withdraw), whichever comes first, in the corresponding part.
Patients still receiving treatment at the cut-off date may continue to receive treatment beyond the cut-off date at investigator's discretion if benefiting.
- Conditions
- Solid Cancer
- Being tested
- cabazitaxel (XRP6258)
- Keywords
- Phase 1, XRP6258, cisplatin, Antineoplastic Combined Chemotherapy Protocols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cabazitaxel (XRP6258)Drug
- administered by IV infusion
- in addition to cisplatin treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | * 5, 15, 20 or 25 mg/m2
* one injection of cabazitaxel on day 1 of each cycle (3 weeks) Receives: Drug: cabazitaxel (XRP6258) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1)
Measured: first cycle (i.e.3 weeks)
Objective response ratio (Complete response (CR) and partial response (PR)) (part 2)
Measured: up to 6 cycles, ie 18 weeks
Pharmacokinetics (PK) of cabazitaxel (part 3 and 4)
Measured: up to 6 cycles, ie 18 weeks
Secondary outcomes (3)
Time to progression (TTP) (part 1 and 2)
Measured: up to 6 cycles, ie 18 weeks
Duration of response (DR) (Part 1 and 2)
Measured: up to 6 cycles, ie 18 weeks
Cabazitaxel pharmacokinetic (part 1 and 2)
Measured: up to 6 cycles, ie 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid CancerStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 76 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
- NCT00925743
- Sponsor's protocol ID
- TCD10870
- Status last verified
- May 2013
- First submitted
- 19 Jun 2009
- Last updated
- 16 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lockhart AC, Sundaram S, Sarantopoulos J, Mita MM, Wang-Gillam A, Moseley JL, Barber SL, Lane AR, Wack C, Kassalow L, Dedieu JF, Mita AC. Phase I dose-escalation study of cabazitaxel administered in combination with cisplatin in patients with advanced solid tumors. Invest New Drugs. 2014 Dec;32(6):1236-45. doi: 10.1007/s10637-014-0145-y. Epub 2014 Aug 13.
PubMed 25117475
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation Study Of The Safety, Tolerability, And Pharmacokinetics Of Cabazitaxel In Combination With Cisplatin Administered Every 3 Weeks In Subjects With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT00925743
- Acronym / sponsor ID
- TCD10870
- Conditions
- Solid Cancer
- Keywords
- Phase 1, XRP6258, cisplatin, Antineoplastic Combined Chemotherapy Protocols
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Jun 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 designed as a phase 1, multicenter, open-label, single arm, dose-escalation, study of Cabazitaxel in combination with cisplatin, to determine safety, pharmacokinetics (PK), and efficacy in solid tumors (parts 1 and 2) and single sequence, two-treatment, crossover studies to determine the effect of strong CYP3A4 inhibition and induction on the PK of Cabazitaxel in patients with solid tumors (part 3 and part 4, respectively).
There are 4 parts to the study:
Part 1: Determine the Dose Limiting Toxicities (DLT)'s and Maximum Tolerated Dose (MTD) based on safety.
Part 2: Determine the anti-tumor activity of the combination regimen at the Maximum Tolerated Dose (MTD) in an extended cohort of patients.
Part 3: Determine the effect of a strong CYP3A4 inhibitor (ketoconazole) on the pharmacokinetic (PK) of Cabazitaxel.
Part 4: Determine the effect of a strong CYP3A4 inducer (rifampin) on the pharmacokinetic (PK) of Cabazitaxel.
Detailed description
The total duration on the study per subject will be about 26 weeks broken down as follows:
- A maximum of 21-day screening phase,
- 21-days (+/- 2 weeks) study treatment cycles,
- 30-day follow-up visit after the last dose of study medication.
- Cut-off date for parts 1, 2, 3 and 4: when the last patient has completed 6 cycles (parts 1 and 2) or 2 cycles (parts 3 and 4) of treatment or discontinued study treatment (for disease progression, unacceptable toxicity, withdrawal of consent, or investigator's decision to withdraw), whichever comes first, in the corresponding part.
Patients still receiving treatment at the cut-off date may continue to receive treatment beyond the cut-off date at investigator's discretion if benefiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: cabazitaxel (XRP6258)* 5, 15, 20 or 25 mg/m2 * one injection of cabazitaxel on day 1 of each cycle (3 weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- confirmed metastatic or unremovable advanced solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, but for which cisplatin based therapy is appropriate
- signed informed consent
Key exclusion criteria (10 listed)
- limited physical functioning (as evaluated by the Eastern Cooperative Oncology Group (ECOG) scale)
- inability to follow study requirements and schedule
- treatment of cancer within 3 weeks of study, concurrent treatment in another clinical trial or with any other cancer therapy
- serious medical illness at same time of study and/or significantly abnormal lab reports
- lack of pregnancy contraception (women of childbearing potential), pregnancy, or breast feeding.
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 (XRP6258)* administered by IV infusion * in addition to cisplatin treatment | Drug | 1 |
Primary outcome
Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1)
Time frame: first cycle (i.e.3 weeks)
Objective response ratio (Complete response (CR) and partial response (PR)) (part 2)
Time frame: up to 6 cycles, ie 18 weeks
Pharmacokinetics (PK) of cabazitaxel (part 3 and 4)
Time frame: up to 6 cycles, ie 18 weeks
3 secondary outcomes
Time to progression (TTP) (part 1 and 2)
Time frame: up to 6 cycles, ie 18 weeks
Duration of response (DR) (Part 1 and 2)
Time frame: up to 6 cycles, ie 18 weeks
Cabazitaxel pharmacokinetic (part 1 and 2)
Time frame: up to 6 cycles, ie 18 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 16 May 2013.
- Derived from this study: PubMed 25117475Lockhart AC, Sundaram S, Sarantopoulos J, Mita MM, Wang-Gillam A, Moseley JL, Barber SL, Lane AR, Wack C, Kassalow L, Dedieu JF, Mita AC. Phase I dose-escalation study of cabazitaxel administered in combination with cisplatin in patients with advanced solid tumors. Invest New Drugs. 2014 Dec;32(6):1236-45. doi: 10.1007/s10637-014-0145-y. Epub 2014 Aug 13.
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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 1 country: 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 Solid Cancer, run by Sanofi at 7 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 2 inclusion and 10 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 16 May 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 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?
Dose Limiting Toxicities (DLT)'s of the combination of cabazitaxel and cisplatin (part 1) (time frame: first cycle (i.e.3 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00925743, which also lists 1 linked publication.
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 16 May 2013.