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APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    2 amendments

    2 re-verifications since 2017-02-10, no change to tracked fields

    v46-v47

  2. Notable

    Results first posted: Dec 28, 2016

    Start date: Apr 2006 to Jun 2006; Enrollment target: estimated 1338 to confirmed 1428; Completion date: May 2009 to Feb 2009; and 5 more

    Show all 9 changes in this update
    • Notable Results first posted: Dec 28, 2016
    • Notable Start date: Apr 2006 to Jun 2006
    • Minor Enrollment target: estimated 1338 to confirmed 1428
    • Minor Completion date: May 2009 to Feb 2009
    • Minor Interventions: APF530 (Drug), dexamethasone (Drug), palonosetron hydrochloride (Drug), placebo (Other) to APF530 (Drug), Palonosetron Hydrochloride (Drug), dexamethasone (Drug), placebo (Other)
    • Minor Secondary endpoints: 10 to 9
      Show what changed
      Proportion of patientsPatients withWith completeComplete controlControl duringDuring the acuteAcute phasePhase (0-24 Hours), delayedDelayed-onset phasePhase (24-120 Hours), and duringDuring chemotherapyChemotherapy courseCourse 1 Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1 Number of Emetic Episodes Time to First Treatment Failure First and Overall Use of Rescue Medication Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 hours) Proportion of patients with total response during the acute phase, delayed-o [...] [...]
    • Minor Primary endpoints revised (2)
      Show what changed
      Proportion of patientsPatients withWith CR duringDuring delayedDelayed-onset phasePhase (24-120 hoursHours) afterAfter administrationAdministration of chemotherapyChemotherapy courseCourse 1 Proportion of patientsPatients withWith completeComplete responseResponse (CR) duringDuring acuteAcute phasePhase (0-24 hoursHours) afterAfter administrationAdministration of chemotherapyChemotherapy courseCourse 1
    • Minor Study description shortened, about 13 words
      Show what changed
      [...] y treatment, patients are followed at approximately 30 days. PROJECTED ACCRUAL: A total of 1,338 patients will be accrued for this study.
    • Minor Study title expanded, about 2 words
      Show what changed
      APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, IPDSharing, Participant Flow, Baseline Characteristicsv45

  3. Minor

    Study Status

    Re-verified, no change to tracked fields

    v44

  4. Minor

    Completion date: May 2009

    Study Statusv43

  5. Minor

    Trial status: Active, Not Recruiting to Completed

    Primary completion date changed from estimate of Jun 2008 to Sep 2008

    Study Statusv42

Show 40 earlier versions

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v41

  2. Minor

    Interventions: APF530 (Drug), dexamethasone (Drug), palonosetron hydrochloride (Drug), placebo (Drug) to APF530 (Drug), dexamethasone (Drug), palonosetron hydrochloride (Drug), placebo (Other)

    Study Status, Arms and Interventionsv40

  3. Minor

    2 amendments

    2 re-verifications since 2008-09-22, no change to tracked fields

    v38-v39

  4. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised at 52 of 52 sites

    Study Status, Contacts/Locationsv37

  5. Minor

    2 amendments

    2 re-verifications since 2008-06-07, no change to tracked fields

    v35-v36

  6. Minor

    Interventions: APF530 (Drug), dexamethasone (Drug), palonosetron hydrochloride (Drug) to APF530 (Drug), dexamethasone (Drug), palonosetron hydrochloride (Drug), placebo (Drug)

    Study arms: 0 to 3

    Study Status, Arms and Interventionsv34

  7. Minor

    Interventions: APF530 (Drug), dexamethasone (Drug), management of therapy complications (Procedure), nausea and vomiting therapy (Procedure), palonosetron… to APF530 (Drug), dexamethasone (Drug), palonosetron hydrochloride (Drug)

    Study Status, Arms and Interventionsv33

  8. Minor

    Study Status

    Re-verified, no change to tracked fields

    v32

  9. Minor

    Interventions: APF530 (Drug), complications of therapy management (Procedure), dexamethasone (Drug), nausea and vomiting therapy (Procedure), palonosetron… to APF530 (Drug), dexamethasone (Drug), management of therapy complications (Procedure), nausea and vomiting therapy (Procedure), palonosetron…

    Study Status, Arms and Interventionsv31

  10. Minor

    Primary completion date: Jun 2008

    Study Statusv30

  11. Minor

    Study sites revised (52)

    Show what changed: Study sites
    Western Washington Oncology, Incorporated, PCPS at Western Washington Cancer Center

    Study Status, Contacts/Locationsv29

  12. Minor

    Study sites revised (52)

    Show what changed: Study sites
    Anniston Oncology, PC

    Study Status, Contacts/Locationsv28

  13. Minor

    Study Status, Contacts/Locations

    v27

  14. Minor

    Study sites revised (52)

    Show what changed: Study sites
    Palo Verde Hematology Oncology, Limited- Glendale

    Study Status, Contacts/Locationsv26

  15. Minor

    Study sites: 57 to 52

    Study Status, Contacts/Locationsv25

  16. Minor

    Interventions: APF530 (Drug), complications of therapy assessment/management (Procedure), dexamethasone (Drug), gastrointestinal complications management… to APF530 (Drug), complications of therapy management (Procedure), dexamethasone (Drug), nausea and vomiting therapy (Procedure), palonosetron…

    Study Status, Arms and Interventionsv24

  17. Minor

    Eligibility criteria shortened, about 10 words

    Show what changed: Eligibility criteria
    [...] Negative pregnancy test Fertile patients must use effective double-method contraception during and for up to 1 year after completion of study treatment No known allergy or hypersensitivity to other selective 5-H [...] g, and 5 days after completion of study treatment More than 107 days since prior chemotherapy More than 107 days since prior and no concurrent prohibited medications ( [...] prior antinausea medications More than 30 days since prior treatment on an investigational drugstrial No other concurrent corticosteroids or dexamethasone at a d [...]

    Study Status, Eligibilityv23

  18. Minor

    Site contacts updated at 1 of 57 sites

    Study Status, Contacts/Locationsv22

  19. Minor

    Study sites revised (57)

    Show what changed: Study sites
    Virginia Oncology Care, P.C.PC

    Study Status, Contacts/Locationsv21

  20. Minor

    Site contacts updated at 1 of 57 sites

    Study Status, Contacts/Locationsv20

  21. Minor

    Site contacts updated at 1 of 57 sites

    Study Status, Contacts/Locationsv19

  22. Minor

    Study sites revised (57)

    Show what changed: Study sites
    Hematology - Medical Oncology Associates at Central Maine Comprehensive Cancer Center

    Study Status, Contacts/Locationsv18

  23. Minor

    Site contacts updated at 2 of 57 sites

    Study Status, Contacts/Locationsv17

  24. Minor

    Study sites: 60 to 57

    Study Status, Contacts/Locationsv16

  25. Minor

    Study Status

    Re-verified, no change to tracked fields

    v15

  26. Minor

    Study sites: 34 to 60

    Study Status, Contacts/Locationsv14

  27. Minor

    Study sites revised (34)

    Show what changed: Study sites
    Charleston Hematology- Oncology Associates, PA

    Study Status, Eligibility, Contacts/Locationsv13

  28. Minor

    Study Status

    Re-verified, no change to tracked fields

    v12

  29. Minor

    Study sites: 28 to 34

    Study Status, Contacts/Locationsv11

  30. Minor

    Site contacts updated at 1 of 28 sites

    Study Status, Contacts/Locationsv10

  31. Minor

    Enrollment target: 1338

    Study sites: 19 to 28; Start date: Apr 2006

    Study Identification, Study Status, Conditions, Study Design, Outcome Measures, Contacts/Locationsv9

  32. Minor

    Study sites: 16 to 19

    Eligibility criteria revised; Study description expanded, about 46 words

    Show what changed: Eligibility criteria
    [...] f moderately or highly emetogenic chemotherapy regimen (for ≥≤ 4 courses) Chemotherapy administration ≤ 4 hours Duration o [...]
    Show what changed: Study description
    [...] cording to emetogenicity of scheduled chemotherapy (moderate-risk [risk level 3 or 4] vs high-risk [risk level 5]). Patients are randomized to 1 of 3 treatment arms [...] SC), and dexamethasone IV on day 1 of chemotherapy course 1. Patients in the high-risk (level 5) stratum also receive oral dexamethasone on days 2-4 of all treatment courses. Arm II: Patients receive APF530 SC, placebo IV, and dexamet [...] and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I. Arm III: Patients receive APF530 SC at a higher dose [...] [...]

    Study Status, Study Description, Eligibility, Contacts/Locationsv8

  33. Minor

    Study sites: 14 to 16

    Study Status, Contacts/Locationsv7

  34. Minor

    Study sites: 13 to 14

    Study Status, Contacts/Locationsv6

  35. Minor

    Study sites: 8 to 13

    Study Status, Contacts/Locationsv5

  36. Minor

    Study sites: 2 to 8

    Study Status, Contacts/Locationsv4

  37. Minor

    Interventions: complications of therapy assessment/management (Procedure), dexamethasone (Drug), gastrointestinal complications management (Procedure)… to APF530 (Drug), complications of therapy assessment/management (Procedure), dexamethasone (Drug), gastrointestinal complications management…

    Eligibility criteria shortened, about 1 word; Study description shortened, about 9 words; Study title revised

    Show what changed: Eligibility criteria
    [...] a different dose than study treatment No concurrent use of granisetron hydrochlorideAPF530, palonosetron hydrochloride, or aprepitant as rescue medications
    Show what changed: Study description
    OBJECTIVES: Primary Compare the overall activity and effects of granisetron hydrochlorideAPF530 versus palonosetron hydrochloride in combination with dexam [...] econdary Evaluate the safety, tolerability, and efficacy of granisetron hydrochlorideAPF530, in terms of prevention of acute- and delayed-onset nausea [...] vomiting, in these patients. Gather the pharmacokinetics of granisetron hydrochlorideAPF530 in a subset of patients during chemotherapy course 1. Gathe [...] courses 2-4. Patients receive palonosetron hydrochloride or granisetron hydrochlorideAPF530 and/or placebo 30-60 minutes before the start of ch [...] [...]
    Show what changed: Study title
    GranisetronAPF530 or Palonosetron Combined With Dexamethasone in Preventing N [...]

    Study Identification, Study Status, Study Description, Arms and Interventions, Eligibilityv3

  38. Minor

    Eligibility criteria shortened, about 1 word

    Study description shortened, about 3 words; Study title expanded, about 3 words

    Show what changed: Eligibility criteria
    [...] ay of moderately or highly emetogenic chemotherapy regimen (for ≥ 4 courses) Chemotherapy administration ≤ 4 hours Duration [...] ild nausea or any vomiting within 24 hours before beginning of study treatment PATIENT CHARACTERISTICS: ECOG performance st [...] t No known allergy or hypersensitivity to other selective 5-HT_3HT3 receptor antagonists or local anesthetics QTc interval ≤ 50 [...] nvestigator, could affect assessment of study medication or might interfere with the nausea/vomiting response (e.g., severe re [...] emetic medications) More than 7 days since prior antinausea medicationmedications More than 30 days [...]
    Show what changed: Study description
    [...] one for prophylaxis of acute- or delayed-onset, chemotherapy-induced nausea and vomiting in patients undergoing moderately or highly emetogenic chemotherapy for cancer. Secondary Evaluate the safety, tolerability, and efficacy [...] during chemotherapy course 1. OUTLINE: This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group, multicenter study. Patients are stratified according to emetogenicity o [...] /or placebo 30-60 minutes before the start of chemotherapy. TheyPatients receive dexamethasone 30-90 minutes before the start of che [...] IV, and dexamethasone IV on day 1 of chemoth [...]
    Show what changed: Study title
    Granisetron or Palonosetron Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

    Study Identification, Study Status, Study Description, Eligibilityv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized phase III trial is studying APF530 and dexamethasone to see how well they work compared with palonosetron and dexamethasone in preventing nausea and vomiting in patients receiving chemotherapy for cancer.
Trial Details
NCT Number NCT00343460
Lead Sponsor Heron Therapeutics
Conditions Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
Enrollment 1,428 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov