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

Sanofi

Status and phase

Completed

Phase 2

Phase 1

Conditions

Gastric Cancer

Treatments

Drug: cabazitaxel XRP6258

Study type

Interventional

Funder types

Industry

Identifiers

NCT01497964

ARD12417

U1111-1121-6247 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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