Trial · NCT00343460
APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
NCT00343460, Phase 3, Completed, Heron Therapeutics; results first posted 2016-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer. Trials, record NCT00343460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00343460
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
- NCT number
- NCT00343460
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,428 participants, actual
- Lead sponsor
- Heron Therapeutics
- Conditions
- Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- APF530, dexamethasone, Palonosetron Hydrochloride, placebo
- First posted
- 2006-06-23
- Last updated
- 2026-03-02
- Results first posted
- 2016-12-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1 | 0-24 Hours | Complete Response is defined as no emetic episodes and no use of rescue medications |
| Primary | Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 | 24-120 Hours | Complete Response is defined as no emetic episodes and no use of rescue medications |
| Secondary | Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1 | 0-120 Hours | Complete control is defined as complete response with no more than mild nausea. |
| Secondary | Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1 | 0-120 Hours | TR during acute phase is defined as Complete Response with no nausea during 0 to 24 hours following the administration of chemotherapy in Cycle 1. TR during delayed-onset phase is defined as Complete Response with no nausea during \>24 to 120 hours following the administration of chemotherapy in Cycle 1. TR during overall risk period is defined as Complete Response with no nausea during 0 to 120 hours following the administration of chemotherapy in Cycle 1. |
| Secondary | Number of Emetic Episodes | Days 1-5 | Number of Emetic Episodes - days 1-5 |
| Secondary | Time to First Treatment Failure | 0-120 Hours | Proportions of subjects event free at 24, 48, 72, 96, and 120 hours after chemotherapy administration |
| Secondary | First and Overall Use of Rescue Medication | 0-120 Hours | |
| Secondary | Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours) | 0-120 Hours | Maximum severity of nausea, days 1-5 |
| Secondary | Sustainability of Antiemetic Effect of APF530 Over Multiple Chemotherapy Courses | 0-120 Hours | Sustainability of Overall Complete Response (CR 0-120 hrs) Over Two, Three, and Four Cycles Complete Response is defined as no emetic episodes and no use of rescue medications |
| Secondary | Quality of Life and the Impact of Nausea and Vomiting on Day 5 | 5 days | Functional Living Index |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1 | 0-24 Hours | Cycle 1 - Modified Intent-to-Treat Population | participants | NUMBER |
| PRIMARY | Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 | 24-120 Hours | Cycle 1 - Modified Intent-to-Treat Population | participants | NUMBER |
| SECONDARY | Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1 | 0-120 Hours | Cycle 1 - Modified Intent-to-Treat Population | participants | NUMBER |
| SECONDARY | Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1 | 0-120 Hours | Cycle 1 - Modified Intent-to-Treat Population | participants | NUMBER |
| SECONDARY | Number of Emetic Episodes | Days 1-5 | Cycle 1 - Modified Intent-to-Treat Population | Number of Emetic Episodes | MEAN |
| SECONDARY | Time to First Treatment Failure | 0-120 Hours | Proportions of subjects event free in Cycle 1 - Modified Intent-to-Treat Population | Proportion of subjects event free | NUMBER |
| SECONDARY | First and Overall Use of Rescue Medication | 0-120 Hours | Cycle 1 - Modified Intent-to-Treat Population | participants | NUMBER |
| SECONDARY | Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours) | 0-120 Hours | Severity of Nausea - Cycle 1 - Modified Intent-to-Treat Population | participants | NUMBER |
| SECONDARY | Sustainability of Antiemetic Effect of APF530 Over Multiple Chemotherapy Courses | 0-120 Hours | Number of subjects in the Modified Intent-to-Treat Population with overall CR (0-120 hrs) in all cycles | participants with overall CR | NUMBER |
| SECONDARY | Quality of Life and the Impact of Nausea and Vomiting on Day 5 | 5 days | Cycle 1 - Modified Intent-to-Treat Population (All Languages Except Punjabi) | participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group148
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1 | Cycle 1 APF530 5 mg - Moderately | 160 | participants | ||
| Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1 | Cycle 1 APF530 10 mg - Moderately | 163 | participants | ||
| Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1 | Cycle 1 Aloxi 0.25 mg - Moderately | 156 | participants | ||
| Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1 | Cycle 1 APF530 5 mg - Highly | 178 | participants | ||
| Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1 | Cycle 1 APF530 10 mg - Highly | 195 | participants | ||
| Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1 | Cycle 1 Aloxi 0.25 Highly | 192 | participants | ||
| Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 | Cycle 1 APF530 5 mg - Moderately | 110 | participants | ||
| Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 | Cycle 1 APF530 10 mg - Moderately | 125 | participants | ||
| Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 | Cycle 1 Aloxi 0.25 mg - Moderately | 120 | participants | ||
| Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1 | Cycle 1 APF530 5 mg - Highly | 148 | participants |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cycle 1 | STARTED | APF530 5 mg | 475 | |
| Cycle 1 | STARTED | APF530 10 mg | 481 | |
| Cycle 1 | STARTED | Aloxi 0.25 mg | 472 | |
| Cycle 1 | COMPLETED | APF530 5 mg | 453 | |
| Cycle 1 | COMPLETED | APF530 10 mg | 459 | |
| Cycle 1 | COMPLETED | Aloxi 0.25 mg | 454 | |
| Cycle 1 | NOT COMPLETED | APF530 5 mg | 22 | |
| Cycle 1 | NOT COMPLETED | APF530 10 mg | 22 | |
| Cycle 1 | NOT COMPLETED | Aloxi 0.25 mg | 18 | |
| Cycle 2 - 4 | STARTED | APF530 5 mg | 584 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events760
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 | Anaemia | Blood and lymphatic system disorders | Cycle 1 APF530 5 mg | 46 | 464 | |
| other | Anaemia | Blood and lymphatic system disorders | Cycle 1 APF530 10 mg | 42 | 468 | |
| other | Anaemia | Blood and lymphatic system disorders | Cycle 1 Aloxi 0.25 mg | 34 | 472 | |
| other | Anaemia | Blood and lymphatic system disorders | Cycles 2-4 APF530 5 mg | 86 | 528 | |
| other | Anaemia | Blood and lymphatic system disorders | Cycle 2-4 APF530 10 mg | 87 | 515 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cycle 1 APF530 5 mg | 39 | 464 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cycle 1 APF530 10 mg | 48 | 468 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cycle 1 Aloxi 0.25 mg | 38 | 472 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cycles 2-4 APF530 5 mg | 46 | 528 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cycle 2-4 APF530 10 mg | 42 | 515 |
1 to 10 of 760Source ClinicalTrials.gov
See all 760 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cycle 1 APF530 5 mg | ||
| Total, all-cause mortality | Cycle 1 APF530 10 mg | ||
| Total, all-cause mortality | Cycle 1 Aloxi 0.25 mg | ||
| Total, all-cause mortality | Cycles 2-4 APF530 5 mg | ||
| Total, all-cause mortality | Cycle 2-4 APF530 10 mg | ||
| Total, other adverse events | Cycle 1 APF530 5 mg | 335 | 464 |
| Total, other adverse events | Cycle 1 APF530 10 mg | 349 | 468 |
| Total, other adverse events | Cycle 1 Aloxi 0.25 mg | 313 | 472 |
| Total, other adverse events | Cycles 2-4 APF530 5 mg | 422 | 528 |
| Total, other adverse events | Cycle 2-4 APF530 10 mg | 413 | 515 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00343460
GET https://conductscience.org/api/trials/v1/NCT00343460/results?page=2