Trial · NCT01724866
Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
NCT01724866, Phase 2, Completed, Spectrum Pharmaceuticals, Inc; results first posted 2022-04-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer. Trials, record NCT01724866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01724866
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer
- NCT number
- NCT01724866
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 148 participants, actual
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Conditions
- Neutropenia
- Interventions
- SPI-2012, Pegfilgrastim, Docetaxel, Cyclophosphamide
- First posted
- 2012-11-12
- Last updated
- 2022-04-15
- Other registries' IDs
- eudract:2013-003094-10
- Results first posted
- 2022-04-15
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Duration of Severe Neutropenia (DSN) in Cycle 1 | Cycle 1 (each cycle was 21 days) | 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. |
| Secondary | Duration of DSN in Cycle 2 | Cycle 2 (each cycle was 21 days) | 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 2. |
| Secondary | Duration of DSN in Cycle 3 | Cycle 3 (each cycle was 21 days) | 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 3. |
| Secondary | Duration of DSN in Cycle 4 | Cycle 4 (each cycle was 21 days) | 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 4. |
| Secondary | Time to ANC Recovery in Cycle 1 | Cycle 1 (each cycle was 21 days) | Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥ 2×10\^9/L after the expected nadir within Cycle 1. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\^9/L within Cycle 1. |
| Secondary | Time to ANC Recovery in Cycle 2 | Cycle 2 (each cycle was 21 days) | Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\^9/L after the expected nadir within Cycle 2. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\^9/L within Cycle 2. |
| Secondary | Time to ANC Recovery in Cycle 3 | Cycle 3 (each cycle was 21 days) | Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\^9/L after the expected nadir within Cycle 3. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\^9/L within Cycle 3. |
| Secondary | Time to ANC Recovery in Cycle 4 | Cycle 4 (each cycle was 21 days) | Time to ANC recovery was defined as the time from chemotherapy administration until ANC increased to ≥2×10\^9/L after the expected nadir within Cycle 4. Time to ANC recovery was not calculated for participants whose ANC value didn't drop below 2 x10\^9/L within Cycle 4. |
| Secondary | Absolute Neutrophil Count (ANC) Nadir Overtime in Cycle 1 | Cycle 1 (each cycle was 21 days) | Mean ANC nadir was defined as the mean of the lowest ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 1. |
| Secondary | Absolute ANC Nadir Overtime in Cycle 2 | Cycle 2 (each cycle was 21 days) | Mean ANC nadir was defined as the mean of the lowest ANC value (\*10\^9/L) after administration of the study drug (SPI-2012 or pegfilgrastim) on any day in Days 1-3 of Cycle 2. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Duration of Severe Neutropenia (DSN) in Cycle 1 | Cycle 1 (each cycle was 21 days) | The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. | days | MEAN |
| SECONDARY | Duration of DSN in Cycle 2 | Cycle 2 (each cycle was 21 days) | The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure. | days | MEAN |
| SECONDARY | Duration of DSN in Cycle 3 | Cycle 3 (each cycle was 21 days) | The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure. | days | MEAN |
| SECONDARY | Duration of DSN in Cycle 4 | Cycle 4 (each cycle was 21 days) | The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure. | days | MEAN |
| SECONDARY | Time to ANC Recovery in Cycle 1 | Cycle 1 (each cycle was 21 days) | The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants with recovery in Cycle 1. | days | MEDIAN |
| SECONDARY | Time to ANC Recovery in Cycle 2 | Cycle 2 (each cycle was 21 days) | The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants with recovery in Cycle 2. | days | MEDIAN |
| SECONDARY | Time to ANC Recovery in Cycle 3 | Cycle 3 (each cycle was 21 days) | The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants with recovery in Cycle 3. | days | MEDIAN |
| SECONDARY | Time to ANC Recovery in Cycle 4 | Cycle 4 (each cycle was 21 days) | The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants with recovery in Cycle 4. | days | MEDIAN |
| SECONDARY | Absolute Neutrophil Count (ANC) Nadir Overtime in Cycle 1 | Cycle 1 (each cycle was 21 days) | The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. | 10^9 ANC per liter | MEAN |
| SECONDARY | Absolute ANC Nadir Overtime in Cycle 2 | Cycle 2 (each cycle was 21 days) | The Evaluable Population included all randomized participants who had received either SPI-2012 or pegfilgrastim and had completed Cycle 1. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure. | 10^9 ANC/L | MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group125
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Duration of Severe Neutropenia (DSN) in Cycle 1 | Arm 1: SPI-2012 45 µg/kg and TC | 1.03 | Standard Deviation 1.547 | days | |
| Duration of Severe Neutropenia (DSN) in Cycle 1 | Arm 2: SPI-2012 135 µg/kg and TC | 0.44 | Standard Deviation 1.275 | days | |
| Duration of Severe Neutropenia (DSN) in Cycle 1 | Arm 3: SPI-2012 270 µg/kg and TC | 0.03 | Standard Deviation 0.167 | days | |
| Duration of Severe Neutropenia (DSN) in Cycle 1 | Arm 4: Pegfilgrastim and TC | 0.31 | Standard Deviation 0.822 | days | |
| Duration of DSN in Cycle 2 | Arm 1: SPI-2012 45 µg/kg and TC | 0.46 | Standard Deviation 1.022 | days | |
| Duration of DSN in Cycle 2 | Arm 2: SPI-2012 135 µg/kg and TC | 0.12 | Standard Deviation 0.478 | days | |
| Duration of DSN in Cycle 2 | Arm 3: SPI-2012 270 µg/kg and TC | 0.03 | Standard Deviation 0.171 | days | |
| Duration of DSN in Cycle 2 | Arm 4: Pegfilgrastim and TC | 0.08 | Standard Deviation 0.368 | days | |
| Duration of DSN in Cycle 3 | Arm 1: SPI-2012 45 µg/kg and TC | 0.45 | Standard Deviation 1.132 | days | |
| Duration of DSN in Cycle 3 | Arm 2: SPI-2012 135 µg/kg and TC | 0.16 | Standard Deviation 0.628 | days |
1 to 10 of 125Source ClinicalTrials.gov
See all 125 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC) | 39 | |
| Overall Study | STARTED | Arm 2: SPI-2012 135 µg/kg and TC | 37 | |
| Overall Study | STARTED | Arm 3: SPI-2012 270 µg/kg and TC | 36 | |
| Overall Study | STARTED | Arm 4: Pegfilgrastim and TC | 36 | |
| Overall Study | Evaluable Population | Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC) | 39 | |
| Overall Study | Evaluable Population | Arm 2: SPI-2012 135 µg/kg and TC | 36 | |
| Overall Study | Evaluable Population | Arm 3: SPI-2012 270 µg/kg and TC | 36 | |
| Overall Study | Evaluable Population | Arm 4: Pegfilgrastim and TC | 36 | |
| Overall Study | COMPLETED | Arm 1: SPI-2012 45 µg/kg and Docetaxel + Cyclophosphamide (TC) | 38 | |
| Overall Study | COMPLETED | Arm 2: SPI-2012 135 µg/kg and TC | 32 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events108
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Arm 1: SPI-2012 45 µg/kg and TC | 17 | 39 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm 2: SPI-2012 135 µg/kg and TC | 7 | 37 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm 3: SPI-2012 270 µg/kg and TC | 14 | 36 | |
| other | Diarrhoea | Gastrointestinal disorders | Arm 4: Pegfilgrastim and TC | 15 | 36 | |
| other | Nausea | Gastrointestinal disorders | Arm 1: SPI-2012 45 µg/kg and TC | 19 | 39 | |
| other | Nausea | Gastrointestinal disorders | Arm 2: SPI-2012 135 µg/kg and TC | 12 | 37 | |
| other | Nausea | Gastrointestinal disorders | Arm 3: SPI-2012 270 µg/kg and TC | 15 | 36 | |
| other | Nausea | Gastrointestinal disorders | Arm 4: Pegfilgrastim and TC | 16 | 36 | |
| other | Asthenia | General disorders | Arm 1: SPI-2012 45 µg/kg and TC | 5 | 39 | |
| other | Asthenia | General disorders | Arm 2: SPI-2012 135 µg/kg and TC | 2 | 37 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: SPI-2012 45 µg/kg and TC | 0 | 39 |
| Total, all-cause mortality | Arm 2: SPI-2012 135 µg/kg and TC | 0 | 37 |
| Total, all-cause mortality | Arm 3: SPI-2012 270 µg/kg and TC | 0 | 36 |
| Total, all-cause mortality | Arm 4: Pegfilgrastim and TC | 0 | 36 |
| Total, other adverse events | Arm 1: SPI-2012 45 µg/kg and TC | 36 | 39 |
| Total, other adverse events | Arm 2: SPI-2012 135 µg/kg and TC | 33 | 37 |
| Total, other adverse events | Arm 3: SPI-2012 270 µg/kg and TC | 33 | 36 |
| Total, other adverse events | Arm 4: Pegfilgrastim and TC | 35 | 36 |
| Total, serious adverse events | Arm 1: SPI-2012 45 µg/kg and TC | 5 | 39 |
| Total, serious adverse events | Arm 2: SPI-2012 135 µg/kg and TC | 4 | 37 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29573207 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01724866
GET https://conductscience.org/api/trials/v1/NCT01724866/registered?page=2