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

NCT01497964 | Completed Phase 1

• 2 other identifiers: ARD12417U1111-1121-6247
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Up to 2 years

Secondary Outcomes (10)

• Overall survival (OS)

  Up to a maximum of 2 years

• Progression free survival (PFS)

  Up to a maximum of 2 years

• Number of patients with adverse events

  Up to a maximum of 2 years

• Pharmacokinetic parameter: Cmax

  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

  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 Arms (1)

Cabazitaxel

EXPERIMENTAL

Cabazitaxel, several dosages

Drug: cabazitaxel XRP6258

Interventions

cabazitaxel XRP6258 DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Cabazitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 410001

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 23, 2011
• Study Start: December 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 10, 2014

Record last verified: 2014-11

Locations

KR (1)