Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Pivotal Phase 3 Observer-Blind, Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared to Aloxi For The Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following The Administration of Either Moderately or Highly Emetogenic Chemotherapy Regimens
RATIONALE: Antiemetic drugs, such as APF530, palonosetron, and dexamethasone, may help
lessen or prevent nausea and vomiting in patients receiving chemotherapy for cancer. It is
not yet known whether APF530 is more effective than palonosetron when given together with
dexamethasone in preventing nausea and vomiting caused by chemotherapy.
PURPOSE: 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.
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.
PROJECTED ACCRUAL: A total of 1,338 patients will be accrued for this study.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
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