Chemotherapy-induced Neutropenia Clinical Trial
— NEUGR-003Official 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
Verified date | February 2023 |
Source | Teva Branded Pharmaceutical Products R&D, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.
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) |
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 |
Lead Sponsor | Collaborator |
---|---|
Teva Branded Pharmaceutical Products R&D, Inc. |
Bulgaria, Romania, Russian Federation, Serbia, Ukraine,
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) |
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