Know Cancer

or
forgot password

A Phase IV Clinical Trial of Patients With Solid Tumours Receiving Granocyte 34 (Granulocyte Colony Stimulating Factor (G-CSF)) as Primary Prophylaxis for Chemotherapy-induced Neutropenia, in a Taxotere (Docetaxel) Based Regimen


Phase 4
21 Years
75 Years
Not Enrolling
Both
Neoplasms (no Otherwise Specified)

Thank you

Trial Information

A Phase IV Clinical Trial of Patients With Solid Tumours Receiving Granocyte 34 (Granulocyte Colony Stimulating Factor (G-CSF)) as Primary Prophylaxis for Chemotherapy-induced Neutropenia, in a Taxotere (Docetaxel) Based Regimen

Inclusion Criteria


Inclusion criteria:

- Patients willing to sign informed consent prior to entry into the study,

- Patients who have been prescribed a Taxotere based regimen,

- Patients who have not yet started with the first Taxotere treatment,

- Patients with a histological diagnosis of one of the following solid tumours: breast
cancer, non-small cell lung cancer (NSCLC), ovarian cancer, prostate cancer, gastric
cancer or head and neck cancer.

Exclusion criteria:

- Patients who are enrolled in another clinical study,

- Pregnant and/or breastfeeding patients, including women of childbearing potential not
willing to use medically acceptable methods of contraception,

- Patients with severe liver impairment,

- Patients with severe renal function impairment,

- Patients with a known hypersensitivity to Granocyte 34 or its constituents,

- Patients with a history of severe hypersensitivity reactions to Taxotere or
Polysorbate 80,

- Patients with a baseline neutrophil count of < 1500cells/mm3,

- Patients on other drugs that are contra-indications for the use with Taxotere,

- Patients on con-current radiotherapy.

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:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and severity of neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Outcome Time Frame:

For each granocyte 34 treatment, from the the study start (visit 1) to the study end (Follow-up visit at 30 (┬▒9) days post Taxotere treatment or with premature withdrawal

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

South Africa: National Health Research Ethics Council

Study ID:

DOCET_L_04775

NCT ID:

NCT01107756

Start Date:

March 2010

Completion Date:

July 2012

Related Keywords:

  • Neoplasms (no Otherwise Specified)
  • Neoplasms
  • Neutropenia

Name

Location