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 (Grano-Tax)

NCT01107756 Phase 4 COMPLETED

Primary Objective: To evaluate the incidence and severity of neutropenia in patients being treated for solid tumours with a Taxotere® based regimen when Granocyte® 34 is being used as a primary prophylaxis for chemotherapy-induced neutropenia. Secondary Objectives: Haematological : To evaluate the incidence and severity of febrile neutropenia (with or without antibiotics) and anaemia in patients being treated for solid tumors treated with a Taxotere based regimen when Granocyte is being used as a primary prophylaxis. Non-Haematological : To evaluate the incidence and severity of the following adverse events: asthenia, anorexia, myalgia, nail changes and oral mucositis in patients with solid tumours treated with a Taxotere based regimen; when Granocyte is being used as a primary prophylaxis.

Details

Lead sponsor	Sanofi
Phase	Phase 4
Status	COMPLETED
Enrolment	403
Start date	2010-03
Completion	2012-07

Conditions

• Neoplasms (no Otherwise Specified)

Interventions

• LENOGRASTIM (GRANOGYTE 34)

Primary outcomes

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

Countries

South Africa