A Phase 4 interventional study of LENOGRASTIM (GRANOGYTE 34) in Neoplasms (no Otherwise Specified), sponsored by Sanofi. Completed at 25 sites in South Africa. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-10-05.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
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.
396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.
This study's enrollment of 403 is above the median of 93 across 276 interventional studies indexed under Neutropenia.
Browse Neutropenia studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Taxotere (Docetaxel) is given as background treatment and should be administered by the treating physician in accordance with the prescribing information outlined in the package insert + Granocyte 34 (lenograstim)
Drug: LENOGRASTIM (GRANOGYTE 34)
Pharmaceutical form: solution Route of administration: intravenous Dose regimen:recommended dosing as per Granocyte 34 package insert
Incidence and severity of neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.
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
Incidence and severity of febrile neutropenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
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
Incidence and severity of anaemia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
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
Incidence and severity of asthenia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
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
Incidence and severity of anorexia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
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
Incidence and severity of myalgia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
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
Incidence and severity of nails changes, including nail disorders assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
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
Incidence and severity of oral mucositis assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4
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
Neutropenia/febrile neutropenia associated days in hospital
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
Neutropenia/febrile neutropenia associated use of anti-infectives
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
Incidence of chemotherapy dose reduction, withdrawals or treatment delays due to neutropenia or febrile neutropenia
Time frame: 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
Infection with (or without) neutropenia
Time frame: 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
Relationship between the incidence and severity of neutropenia and the different chemotherapy regimens
Time frame: 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
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi