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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-9574 | Other Identifier | UTN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAXOTERE (Docetaxel) + GRANOGYTE 34 (Lenograstim) | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LENOGRASTIM (GRANOGYTE 34) | Drug | Pharmaceutical form: solution Route of administration: intravenous Dose regimen:recommended dosing as per Granocyte 34 package insert |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of febrile 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 | |
| Incidence and severity of anaemia assessed by using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 53 | Alberton | South Africa | ||||
| Investigational Site Number 55 |
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| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Benoni |
| South Africa |
| Investigational Site Number 11 | Bloemfontein | 9301 | South Africa |
| Investigational Site Number 21 | Cape Town | 7460 | South Africa |
| Investigational Site Number 27 | Cape Town | 7500 | South Africa |
| Investigational Site Number 26 | Cape Town | 7800 | South Africa |
| Investigational Site Number 22 | Cape Town | 7925 | South Africa |
| Investigational Site Number 13 | Durban | 4001 | South Africa |
| Investigational Site Number 14 | Durban | 4091 | South Africa |
| Investigational Site Number 32 | East London | South Africa |
| Investigational Site Number 012 | eManzimtoti | 4126 | South Africa |
| Investigational Site Number 24 | George | 6530 | South Africa |
| Investigational Site Number 51 | Johannesburg | 1709 | South Africa |
| Investigational Site Number 12387 | Johannesburg | 2000 | South Africa |
| Investigational Site Number 47 | Klerksdorp | 2572 | South Africa |
| Investigational Site Number 43 | Mbombela | 1200 | South Africa |
| Investigational Site Number 44 | Polokwane | 0699 | South Africa |
| Investigational Site Number 31 | Port Elizabeth | 6045 | South Africa |
| Investigational Site Number 42 | Pretoria | 0084 | South Africa |
| Investigational Site Number 41 | Pretoria | 0102 | South Africa |
| Investigational Site Number 451 | Pretoria | South Africa |
| Investigational Site Number 48 | Rustenburg | South Africa |
| Investigational Site Number 54 | Sandton | 2193 | South Africa |
| Investigational Site Number 25 | Somerset West | South Africa |
| Investigational Site Number 56 | Vereeniging | South Africa |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000078224 | Lenograstim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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