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NCT01724866 · ClinicalTrials.gov registry record · Phase 2

Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer

A Phase 2 study, sponsored by Spectrum Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
148
Enrollment target

NCT01724866: Completed Phase 2 study, sponsored by Spectrum Pharmaceuticals.

NCT01724866 is a Phase 2 study that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 148 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01724866, a Phase 2 study, has completed, sponsored by Spectrum Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
148 participants
Enrollment target

Study 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.

Primary Outcome

DSN was defined as the interval from the day of first observation of severe neutropenia (ANC \<0.5\*10\^9/L, Grade 4 neutropenia per NCI CTCAE) to the first ANC recovery to =\> 2.0\*10\^9/L in Cycle 1.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Docetaxel
  • DRUG Pegfilgrastim
  • DRUG SPI-2012

Trial Details

FieldValue
Enrollment Target 148 participants
Start Date 2013-03-25
Est. Completion 2014-08-12
Phase Phase 2
Spectrum Pharmaceuticals

52 total trials

What the finished NCT01724866 record still lists

NCT01724866 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).

The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT01724866 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01724866 about?

NCT01724866 is a clinical study titled "Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer". 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.

What is the current status of trial NCT01724866?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 148 participants. The study started on 2013-03-25. Estimated completion is 2014-08-12.

What interventions are being tested in trial NCT01724866?

The interventions under investigation include: Cyclophosphamide (DRUG), Docetaxel (DRUG), Pegfilgrastim (DRUG), SPI-2012 (DRUG).

Who is sponsoring clinical trial NCT01724866?

This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01724866's enrollment target sits among peer trials

148 491st of 2000 higher than 1,506 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01724866, the US trial registry maintained by the National Library of Medicine. NCT01724866 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.