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

StatusCompleted
PhasePhase 3
Started

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Record History

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  1. 2 versions Re-verified since Feb 10, 2017, no change to tracked fieldsv46-v47
  2. Results first posted: Dec 28, 2016v45 Show 8 more changesShow less
    • Start date: Apr 2006 to Jun 2006
    • Enrollment target: estimated 1338 to confirmed 1428
    • Study completion date: May 2009 to Feb 2009
    • Interventions: APF530 (Drug), dexamethasone (Drug), palonosetron hydrochloride (Drug), placebo (Other) to APF530 (Drug), Palonosetron Hydrochloride (Drug), dexamethasone (Drug), placebo (Other)
    • Secondary endpoints: 10 to 9
    • Primary endpoints revised (2)
    • Study description shortened, about 13 words
    • Study title expanded, about 2 words
  3. Re-verified, no change to tracked fieldsv44
  4. Study completion date: May 2009v43
  5. Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of Jun 2008 to Sep 2008
    v42
Show 40 earlier versionsHide 40 earlier versions
  1. Re-verified, no change to tracked fieldsv41
  2. Interventions: APF530 (Drug), dexamethasone (Drug), palonosetron hydrochloride (Drug), placebo (Drug) to APF530 (Drug), dexamethasone (Drug), palonosetron hydrochloride (Drug), placebo (Other)v40
  3. 2 versions Re-verified since Sep 22, 2008, no change to tracked fieldsv38-v39
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 52 of 52 sites
    v37
  5. 2 versions Re-verified since Jun 7, 2008, no change to tracked fieldsv35-v36
  6. Interventions: APF530 (Drug), dexamethasone (Drug), palonosetron hydrochloride (Drug) to APF530 (Drug), dexamethasone (Drug), palonosetron hydrochloride (Drug), placebo (Drug)
    • Study arms: 0 to 3
    v34
  7. Interventions: APF530 (Drug), dexamethasone (Drug), management of therapy complications (Procedure), nausea and vomiting therapy (Procedure), palonosetron… to APF530 (Drug), dexamethasone (Drug), palonosetron hydrochloride (Drug)v33
  8. Re-verified, no change to tracked fieldsv32
  9. 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…v31
  10. Primary completion date: Jun 2008v30
  11. Study sites revised (52)v29
  12. Study sites revised (52)v28
  13. Study Status, Contacts/Locationsv27
  14. Study sites revised (52)v26
  15. Study sites: 57 to 52v25
  16. 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…v24
  17. Eligibility criteria shortened, about 10 wordsv23
  18. Site contacts updated at 1 of 57 sitesv22
  19. Study sites revised (57)v21
  20. Site contacts updated at 1 of 57 sitesv20
  21. Site contacts updated at 1 of 57 sitesv19
  22. Study sites revised (57)v18
  23. Site contacts updated at 2 of 57 sitesv17
  24. Study sites: 60 to 57v16
  25. Re-verified, no change to tracked fieldsv15
  26. Study sites: 34 to 60v14
  27. Study sites revised (34)v13
  28. Re-verified, no change to tracked fieldsv12
  29. Study sites: 28 to 34v11
  30. Site contacts updated at 1 of 28 sitesv10
  31. Enrollment target: 1338
    • Study sites: 19 to 28
    • Start date: Apr 2006
    v9
  32. Study sites: 16 to 19
    • Eligibility criteria revised
    • Study description expanded, about 46 words
    v8
  33. Study sites: 14 to 16v7
  34. Study sites: 13 to 14v6
  35. Study sites: 8 to 13v5
  36. Study sites: 2 to 8v4
  37. 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…
    • Study description shortened, about 9 words
    • Study title revised
    • Eligibility criteria shortened, about 1 word
    v3
  38. Eligibility criteria shortened, about 1 word
    • Study description shortened, about 3 words
    • Study title expanded, about 3 words
    v2
  1. Study First Submitted
  • 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
(from sponsor)		 Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
Related terms Nausea, Vomiting
Enrollment 1,428 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov