Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343460
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2006-06-22
Brief Title:
APF530 or Aloxi Palonosetron Hydrochloride Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer
Sponsor:
Heron Therapeutics
Organization:
Heron Therapeutics
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| APPA-C2006-01 | None | None | None |