CompletedNCT01497964GASTANAUpdated Nov 10, 2014

Cabazitaxel in Asian Patients With Advanced Gastric Cancer Who Failed Prior Chemotherapy

A Phase 1/2 interventional study of cabazitaxel XRP6258 in Gastric Cancer, sponsored by Sanofi. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-10.

Sponsored by Sanofi · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 16
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Gastric Cancer

Browse trials for

Stomach Neoplasms 2,851

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 16 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

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
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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 16 participants (actual)

Study arms

Experimental
Cabazitaxel
Cabazitaxel, several dosages
Drug: cabazitaxel XRP6258

Interventions

Drugcabazitaxel XRP6258
Pharmaceutical form: solution for infusion Route of administration: intravenous

What researchers measure

Primary outcomes

Objective Response Rate
Time frame: Up to 2 years

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

Study locations

1 site

Investigational Site Number 410001
Seoul, 138-736, Korea, Republic of

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01497964
Lead sponsor: Sanofi
Responsible party: Sponsor
First posted: Dec 23, 2011
Start date: Dec 2011
Primary completion: May 2013
Completion: May 2013
Last update: Nov 10, 2014

Study contacts

Clinical Sciences & Operations

study director · Sanofi

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stomach Neoplasms→

Other studies from this sponsor

Sanofi

Start the discussion