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NCT03135951 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy
A Phase 1 study, sponsored by Spectrum Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03135951: Completed Phase 1 study, sponsored by Spectrum Pharmaceuticals.
NCT03135951 is a Phase 1 study that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03135951, a Phase 1 study, has completed, sponsored by Spectrum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days following drug administration.
Primary Outcome
PK samples will be collected at predetermined time intervals and Peak Concentration is measured at highest value among all concentrations.
Interventions
- DRUG SPI-2012
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-05-11 |
| Est. Completion | 2018-05-18 |
| Phase | Phase 1 |
What the finished NCT03135951 record still lists
NCT03135951 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which SPI-2012 is the first listed.
NCT03135951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03135951 about?
NCT03135951 is a clinical study titled "Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy". The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days following drug administrati...
What is the current status of trial NCT03135951?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2017-05-11. Estimated completion is 2018-05-18.
What interventions are being tested in trial NCT03135951?
The interventions under investigation include: SPI-2012 (DRUG).
Who is sponsoring clinical trial NCT03135951?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03135951's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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