APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Condition: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the overall activity and effects of APF530 versus palonosetron hydrochloride in
           combination with dexamethasone 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 of APF530, in terms of prevention of
           acute- and delayed-onset nausea and vomiting, in these patients.

        -  Gather the pharmacokinetics of APF530 in a subset of patients during chemotherapy course
           1.

        -  Gather ECG data (using 24-hour Holter monitoring) in a subset of patients during
           chemotherapy course 1.

      OUTLINE: This is a randomized, placebo-controlled, double-blind, parallel-group, multicenter
      study. Patients are stratified according to emetogenicity of scheduled chemotherapy
      (moderate-risk [level 3 or 4] vs high-risk [level 5]). Patients are randomized to 1 of 3
      treatment arms (I, II, and III). Patients who are randomized to receive palonosetron
      hydrochloride during chemotherapy course 1 (arm I) are then re-randomized to 1 of 2 treatment
      arms (II and III) after chemotherapy course 1 to receive treatment during chemotherapy
      courses 2-4.

      Patients receive palonosetron hydrochloride or APF530 and/or placebo 30-60 minutes before the
      start of chemotherapy. Patients receive dexamethasone 30-90 minutes before the start of
      chemotherapy.

        -  Arm I: Patients receive palonosetron hydrochloride IV, placebo subcutaneously (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 dexamethasone IV on day 1 of
           chemotherapy course 1. Patients then receive APF530 SC 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, placebo IV, and dexamethasone IV
           on day 1 of chemotherapy course 1. Patients then receive APF530 SC (at the same higher
           dose) 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.

      A subset of patients undergo blood collection periodically during study for analysis of
      plasma APF530 concentration.

      Quality of life is assessed on day 5 after completion of chemotherapy course 1.

      After completion of study treatment, patients are followed at approximately 30 days.
    

Intervention name(s): APF530; dexamethasone; Palonosetron Hydrochloride; placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Given subcutanously; Given IV and orally; Given IV; Given subcutanously or IV
Intervention MeSH terms: Dexamethasone; Palonosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: nausea and vomiting; unspecified adult solid tumor, protocol specific