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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01497964
First received: December 6, 2011
Last updated: April 11, 2014
Last verified: April 2014

December 6, 2011
April 11, 2014
December 2011
May 2013   (final data collection date for primary outcome measure)
Objective Response Rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01497964 on ClinicalTrials.gov Archive Site
  • Overall survival (OS) [ Time Frame: Up to a maximum of 2 years ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) [ Time Frame: Up to a maximum of 2 years ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: Up to a maximum of 2 years ] [ Designated as safety issue: Yes ]
  • 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.. ] [ Designated as safety issue: No ]
  • 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.. ] [ Designated as safety issue: No ]
  • 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.. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cabazitaxel in Asian Patients With Advanced Gastric Cancer Who Failed Prior Chemotherapy
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

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.

Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
Drug: cabazitaxel XRP6258
Pharmaceutical form: solution for infusion Route of administration: intravenous
Experimental: Cabazitaxel
Cabazitaxel, several dosages
Intervention: Drug: cabazitaxel XRP6258
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
May 2013
May 2013   (final data collection date for primary outcome measure)

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:

  • 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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01497964
ARD12417, U1111-1121-6247
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP