At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 148 enrolled
Drug / intervention
SPI-2012 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2, Open-Label, Dose-Ranging Study of SPI-2012 (HM10460A) or Pegfilgrastim Use for the Management of Neutropenia in Patients With Breast Cancer Who Are Candidates for Adjuvant and Neoadjuvant Chemotherapy With the Docetaxel + Cyclophosphamide (TC) Regimen
In Brief
A Phase 2 clinical trial evaluating SPI-2012, Pegfilgrastim, and 2 other interventions for Neutropenia. Completed, enrolled 148 participants across 27 sites in 6 countries.
Detailed Summary
The purpose of this study is to assess the effect of test doses of SPI-2012 on the duration of severe neutropenia (DSN) during Cycle 1 in participants with breast cancer who are candidates for adjuvant or neoadjuvant chemotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeutropenia
CountriesAustralia, Georgia, Hungary, Israel, Poland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartMar 2013
Primary CompletionAug 2014
TodayJul 2026
First PostedNov 12, 2012
Enrollment StartMar 25, 2013
Primary CompletionAug 12, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.6 years ago
Interventions
SPI-2012drug
SPI-2012 SC injection.
Pegfilgrastimdrug
Pegfilgrastim SC injection, per manufacturer's Prescribing Information.
Docetaxeldrug
Docetaxel given based on standard dose for chemotherapy.
Cyclophosphamidedrug
Cyclophosphamide given based on standard dose for chemotherapy.