Gastric CancerPhase 1/2GASTANANCT01497964
Cabazitaxel in Asian Patients With Advanced Gastric Cancer Who Failed Prior Chemotherapy
A Phase 1/2 study testing cabazitaxel XRP6258 in people with Gastric Cancer, run by Sanofi at 1 site in South Korea.
Trial summary
Primary Objective: To evaluate the anti-tumor activity of cabazitaxel by assessing objective tumor response rate (ORR) at the recommended dose (RD) when administered as a single agent every 3 weeks in patients with advanced gastric adenocarcinoma who have failed prior chemotherapy regimens Secondary Objectives: To… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric 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
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to May 2013
- Phase
- Phase 1/2
- 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
- Histologically or cytologically confirmed unresectable or metastatic gastric adenocarcinoma including adenocarcinoma of gastroesophageal junction, which have failed 2 prior chemotherapy regimens. (For countries where a standard of care has not been established for the 2nd line treatment for advanced gastric cancer, those who failed 1 or 2 prior chemotherapy regimens can be included)
- Signed informed consent
Who cannot join
- Patients who have received >2 prior systemic chemotherapy regimens for advanced gastric cancer.
- For patients entering part 2, those without at least one measurable lesion at baseline according to Response Evaluation Criteria in Solid Tumors 1.1 criteria
- Eastern Cooperative Oncology Group performance status >1
- Age <18 years
- Inadequate organ and bone marrow function
- Prior surgery, chemotherapy, targeted agents, investigational agents, or other anti-cancer therapy within 4 weeks prior to enrollment in the study
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- Prior radiation therapy within 6 weeks prior to enrollment (except palliative radiation for a local pain control)
- Previous treatment with cabazitaxel
- Known brain or leptomeningeal involvement of cancer
- Patients with known acquired immunodeficiency syndrome (AIDS) related illness or known HIV infection requiring antiretroviral treatment.
- Patients with active varicella zoster infection, or known hepatitis B or C infection.
- History of severe hypersensitivity reaction ≥ grade 3 to drugs formulated with polysorbate 80 such as docetaxel
- 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
1 site in 1 country.
About this study
Official title: A Phase 2, Multicenter Study of Cabazitaxel Single Agent Administered as a 1-Hour Intravenous Infusion Every 3 Weeks to Evaluate the Safety, Tolerability and Anti-tumor Activity of Cabazitaxel in Patients With Advanced Gastric Adenocarcinoma Who Have Failed Prior Chemotherapy Regimens
Primary Objective:
- To evaluate the anti-tumor activity of cabazitaxel by assessing objective tumor response rate (ORR) at the recommended dose (RD) when administered as a single agent every 3 weeks in patients with advanced gastric adenocarcinoma who have failed prior chemotherapy regimens
Secondary Objectives:
- To determine the RD of cabazitaxel when administered as a single agent every 3 weeks
- To evaluate safety of cabazitaxel when administered as a single agent every 3 weeks
- To estimate the overall survival (OS) and progression free survival (PFS)
- To assess the pharmacokinetics (PK) profile of cabazitaxel in part 1
Read the detailed description
Patients will be treated until disease progression, unacceptable toxicity, or patient's refusal of further study treatment. All patients will be followed during and after the study treatment until death or the end of study, whichever comes first.
- Conditions
- Gastric Cancer
- Being tested
- cabazitaxel XRP6258
- Medical subject headings
- Stomach 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 |
|---|---|---|
| Cabazitaxel | Experimental | Cabazitaxel, several dosages Receives: Drug: cabazitaxel XRP6258 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: Up to 2 years
Secondary outcomes (10)
Overall survival (OS)
Measured: Up to a maximum of 2 years
Progression free survival (PFS)
Measured: Up to a maximum of 2 years
Number of patients with adverse events
Measured: Up to a maximum of 2 years
Pharmacokinetic parameter: Cmax
Measured: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
Pharmacokinetic parameter tmax
Measured: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
Pharmacokinetic parameter t1/2z
Measured: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
Pharmacokinetic parameter AUC
Measured: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Pharmacokinetic parameter AUClast
Measured: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Pharmacokinetic parameter CL
Measured: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Pharmacokinetic parameter Vss
Measured: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT01497964
- Sponsor's protocol ID
- ARD12417
- Other IDs
- U1111-1121-6247
- Acronym
- GASTANA
- Status last verified
- Nov 2014
- First submitted
- 6 Dec 2011
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter Study of Cabazitaxel Single Agent Administered as a 1-Hour Intravenous Infusion Every 3 Weeks to Evaluate the Safety, Tolerability and Anti-tumor Activity of Cabazitaxel in Patients With Advanced Gastric Adenocarcinoma Who Have Failed Prior Chemotherapy Regimens
- ClinicalTrials.gov ID
- NCT01497964
- Acronym / sponsor ID
- GASTANA / ARD12417
- Conditions
- Gastric Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Dec 2011 (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 evaluate the anti-tumor activity of cabazitaxel by assessing objective tumor response rate (ORR) at the recommended dose (RD) when administered as a single agent every 3 weeks in patients with advanced gastric adenocarcinoma who have failed prior chemotherapy regimens
Secondary Objectives:
- To determine the RD of cabazitaxel when administered as a single agent every 3 weeks
- To evaluate safety of cabazitaxel when administered as a single agent every 3 weeks
- To estimate the overall survival (OS) and progression free survival (PFS)
- To assess the pharmacokinetics (PK) profile of cabazitaxel in part 1
Detailed description
Patients will be treated until disease progression, unacceptable toxicity, or patient's refusal of further study treatment. All patients will be followed during and after the study treatment until death or the end of study, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel | Experimental | Drug: cabazitaxel XRP6258Cabazitaxel, several dosages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically or cytologically confirmed unresectable or metastatic gastric adenocarcinoma including adenocarcinoma of gastroesophageal junction, which have failed 2 prior chemotherapy regimens. (For countries where a standard of care has not been established for the 2nd line treatment for advanced gastric cancer, those who failed 1 or 2 prior chemotherapy regimens can be included)
- Signed informed consent
Key exclusion criteria (13 listed)
- Patients who have received >2 prior systemic chemotherapy regimens for advanced gastric cancer.
- For patients entering part 2, those without at least one measurable lesion at baseline according to Response Evaluation Criteria in Solid Tumors 1.1 criteria
- Eastern Cooperative Oncology Group performance status >1
- Age <18 years
- Inadequate organ and bone marrow function
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 | Cabazitaxel |
Primary outcome
Objective Response Rate
Time frame: Up to 2 years
10 secondary outcomes
Overall survival (OS)
Time frame: Up to a maximum of 2 years
Progression free survival (PFS)
Time frame: Up to a maximum of 2 years
Number of patients with adverse events
Time frame: Up to a maximum of 2 years
Pharmacokinetic parameter: Cmax
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
Pharmacokinetic parameter tmax
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
Pharmacokinetic parameter t1/2z
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion..
Pharmacokinetic parameter AUC
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Pharmacokinetic parameter AUClast
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Pharmacokinetic parameter CL
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
Pharmacokinetic parameter Vss
Time frame: pre-infusion, end of infusion, 5, 15, 30 min, 1, 3, 5, 8 hours after end of infusion, 24, 48, 72, 120, 168, 216 hours after start of infusion
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 10 Nov 2014.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing cabazitaxel XRP6258 in people with Gastric Cancer, run by Sanofi at 1 site in South Korea.
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 13 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 10 Nov 2014. 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 South Korea. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Objective Response Rate (time frame: Up to 2 years). 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 10 Nov 2014.