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

This study is currently recruiting participants.
Verified July 2012 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01497964
First received: December 6, 2011
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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

Condition Intervention Phase
Gastric Cancer
 Drug: cabazitaxel XRP6258
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Cabazitaxel
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabazitaxel
Cabazitaxel, several dosages
 Drug: cabazitaxel XRP6258
Pharmaceutical form: solution for infusion Route of administration: intravenous

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497964

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi-aventis.com

Locations
Korea, Republic of
Investigational Site Number 410001 Recruiting
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01497964     History of Changes
Other Study ID Numbers: ARD12417, U1111-1121-6247
Study First Received: December 6, 2011
Last Updated: July 25, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on May 23, 2013