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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective Response Rate

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Korea: Food and Drug Administration

Study ID:

ARD12417

NCT ID:

NCT01497964

Start Date:

January 2012

Completion Date:

June 2013

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

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