Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel

Chemotherapy-induced Neutropenia Clinical Trial

— NEUGR-003  

Official title:

A Randomized, Double-Blind, Active Comparator, Non-Inferiority Study of Subcutaneously Administered Neugranin (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) or Pegfilgrastim in Subjects With Breast Cancer Receiving Myelosuppressive Chemotherapy (Doxorubicin/Docetaxel), Followed by a Single-Arm, Open-Label Phase of Subcutaneously Administered Neugranin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126190
• Other study ID #: NEUGR-003
• Status: Completed
• Phase: Phase 3
• Start date: June 30, 2010
• Est. completion date: February 29, 2012

Study information

• Verified date: February 2023
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: February 29, 2012
• Est. primary completion date: February 29, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel)

Exclusion Criteria:

• Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months)

Related Conditions & MeSH terms

• Chemotherapy-induced Neutropenia
• Neutropenia

Intervention

Biological:
• Neugranin
Neugranin will be administered per dose and schedule specified in the arm description.
• Pegfilgrastim
Pegfilgrastim will be administered per dose and schedule specified in the arm description.

Drug:
• Chemotherapy
The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m^2 and docetaxel 75 mg/m^2 in combination

Locations

Country	Name	City	State
Bulgaria	Teva Investigational Site 3502	Gabrovo
Bulgaria	Teva Investigational Site 3511	Plovdiv
Bulgaria	Teva Investigational Site 3504	Ruse
Bulgaria	Teva Investigational Site 3501	Shumen
Bulgaria	Teva Investigational Site 3506	Sofia District
Bulgaria	Teva Investigational Site 3503	Stara Zagora
Bulgaria	Teva Investigational Site 3505	Varna
Bulgaria	Teva Investigational Site 3507	Veliko Tarnovo
Romania	Teva Investigational Site 4001	Baia Mare, Maramures County
Romania	Teva Investigational Site 4009	Brasov
Romania	Teva Investigational Site 4004	Bucharest
Romania	Teva Investigational Site 4002	Cluj Napoca
Romania	Teva Investigational Site 4011	Cluj-Napoca
Romania	Teva Investigational Site 4005	Craiova, Dolj County
Romania	Teva Investigational Site 4010	Lasi County
Romania	Teva Investigational Site 4007	Timisoara
Russian Federation	Teva Investigational Site 0714	Arkhangelsk
Russian Federation	Teva Investigational Site 0707	Chelyabinsk
Russian Federation	Teva Investigational Site 0702	Ekaterinburg
Russian Federation	Teva Investigational Site 0708	Ivanovo
Russian Federation	Teva Investigational Site 0721	Kazan
Russian Federation	Teva Investigational Site 0709	Krasnodar
Russian Federation	Teva Investigational Site 0711	Kursk
Russian Federation	Teva Investigational Site 0713	Leningrad Region
Russian Federation	Teva Investigational Site 0703	Moscow
Russian Federation	Teva Investigational Site 0710	Moscow
Russian Federation	Teva Investigational Site 0716	Nizhny Novgorod
Russian Federation	Teva Investigational Site 0720	Orel
Russian Federation	Teva Investigational Site 0724	Pyatigorsk
Russian Federation	Teva Investigational Site 0725	Rostov-on-Don
Russian Federation	Teva Investigational Site 0704	Saint Petersburg
Russian Federation	Teva Investigational Site 0706	Saint Petersburg
Russian Federation	Teva Investigational Site 0715	Saint Petersburg
Russian Federation	Teva Investigational Site 0722	Saint Petersburg
Russian Federation	Teva Investigational Site 0712	Samara
Russian Federation	Teva Investigational Site 0723	Sochi
Russian Federation	Teva Investigational Site 0717	Tambov
Russian Federation	Teva Investigational Site 0719	Ufa
Russian Federation	Teva Investigational Site 0705	Yaroslavl
Serbia	Teva Investigational Site 8102	Belgrade
Serbia	Teva Investigational Site 8103	Belgrade
Serbia	Teva Investigational Site 8104	Kragujevac
Serbia	Teva Investigational Site 8105	Nis
Ukraine	Teva Investigational Site 3807	Chernihiv
Ukraine	Teva Investigational Site 3805	Chernivtsi
Ukraine	Teva Investigational Site 3802	Dnipropetrovsk
Ukraine	Teva Investigational Site 3811	Donetsk
Ukraine	Teva Investigational Site 3806	Ivano-Frankivsk
Ukraine	Teva Investigational Site 3804	Kharkiv
Ukraine	Teva Investigational Site 3814	Kharkiv
Ukraine	Teva Investigational Site 3816	Kharkiv
Ukraine	Teva Investigational Site 3803	Khmelnytskyi
Ukraine	Teva Investigational Site 3808	Kyiv
Ukraine	Teva Investigational Site 3817	Kyiv
Ukraine	Teva Investigational Site 3812	Lviv
Ukraine	Teva Investigational Site 3809	Mariupol, Donetsk Region
Ukraine	Teva Investigational Site 3801	Odesa
Ukraine	Teva Investigational Site 3815	Sumy
Ukraine	Teva Investigational Site 3810	Uzhhorod

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

Bulgaria,  Romania,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Double-Blind Phase: Duration of Severe Neutropenia in Cycle 1	Severe neutropenia was defined as Grade 4 neutropenia (absolute neutrophil count [ANC] <0.5 x 10^9/liter [L]). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC =0.5 x 10^9/L within the cycle.	Cycle 1 (cycle length = 21 days)
Primary	Open-Label Phase: Duration of Severe Neutropenia in Cycle 1	Severe neutropenia was defined as Grade 4 neutropenia (ANC <0.5 x 10^9/L). The duration of severe neutropenia was calculated by cycle as the number of days from the first day in which the ANC fell below 0.5 x 10^9/L after beginning a chemotherapy cycle until the participant had an ANC =0.5 x 10^9/L within the cycle. There was no planned statistical analysis for the open-label phase arm.	Cycle 1 (cycle length = 21 days)
Secondary	Double-Blind Phase: Number of Participants With Febrile Neutropenia	Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and body temperature >38.5 degrees celsius (°C) occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.	Cycles 1-4 (each cycle = 21 days)
Secondary	Open-Label Phase: Number of Participants With Febrile Neutropenia	Febrile neutropenia was defined as an imputed or observed ANC <0.5 x 10^9/L and body temperature >38.5 °C occurring on the same day and for more than one hour (axillary measurement). Number of participants with febrile neutropenia over all cycles (Cycles 1 to 4) has been reported.	Cycles 1-4 (each cycle = 21 days)