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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.

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.

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.

APF530

dexamethasone

Palonosetron Hydrochloride

placebo

John Barr, PhD

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.

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

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

Complete Response is defined as no emetic episodes and no use of rescue medications

Complete control is defined as complete response with no more than mild nausea.

TR during acute phase is defined as Complete Response with no nausea during 0 to 24 hours following the administration of chemotherapy in Cycle 1.

TR during delayed-onset phase is defined as Complete Response with no nausea during \>24 to 120 hours following the administration of chemotherapy in Cycle 1. TR during overall risk period is defined as Complete Response with no nausea during 0 to 120 hours following the administration of chemotherapy in Cycle 1.

Proportions of subjects event free at 24, 48, 72, 96, and 120 hours after chemotherapy administration

Sustainability of Overall Complete Response (CR 0-120 hrs) Over Two, Three, and Four Cycles

Complete Response is defined as no emetic episodes and no use of rescue medications

Heron Therapeutics

Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population

Cycle 1 APF530 5 mg

Cycle 1 APF530 10 mg

Cycle 1 Aloxi 0.25 mg

Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population

Cycles 2-4 APF530 5 mg

Cycle 2-4 APF530 10 mg

Cycle 1 - Modified Intent-to-Treat Population

Emetogenic Status: Moderately

Cycle 1 APF530 5 mg - Moderately

Cycle 1 APF530 10 mg - Moderately

Cycle 1 Aloxi 0.25 mg - Moderately

Cycle 1 - Modified Intent-to-Treat Population

Emetogenic Status: Highly

Cycle 1 APF530 5 mg - Highly

Cycle 1 APF530 10 mg - Highly

Cycle 1 Aloxi 0.25 Highly

Total

Age, Continuous

Sex: Female, Male

Robert Geller, M.D.

Cycle 1 - Modified Intent-to-Treat Population

Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1

Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1

CC during acute Phase

CC during the delayed-onset phase

CC during the overall risk period

Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1

TR during acute phase

TR during the delayed-onset phase

TR during the overall risk period

Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1

Number of Emetic Episodes

24 Hours

48 Hours

72 Hours

96 Hours

120 Hours

Cycle 1 Aloxi 0.25 - Highly

Proportions of subjects event free in Cycle 1 - Modified Intent-to-Treat Population

Time to First Treatment Failure

Used Rescue Medication, 0-24 hours

Used Rescue Medication, 24-120 hours

Used Rescue Medication, 0-120 hours

First and Overall Use of Rescue Medication

None

Mild

Moderate

Severe

Severity of Nausea - Cycle 1 - Modified Intent-to-Treat Population

Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours)

Cycles 1, 2, 3 and 4 - Moderately

Cycles 1, 2, 3, and 4 - Moderately

Cycles 1, 2, 3 and 4 - Highly

Cycles 1, 2, 3, and 4 - Highly

Number of subjects in the Modified Intent-to-Treat Population with overall CR (0-120 hrs) in all cycles

Sustainability of Antiemetic Effect of APF530 Over Multiple Chemotherapy Courses

No nausea impact on daily life

No vomiting impact on daily life

Cycle 1 - Modified Intent-to-Treat Population (All Languages Except Punjabi)

Quality of Life and the Impact of Nausea and Vomiting on Day 5

Patient's Global Satisfaction With Antiemetic Therapy During Acute Phase and Chemotherapy Course 1

Spots Global Cancer Trial Database for apf530

Every month we try and update this database with for apf530 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for apf530

Every month we try and update this database with for apf530 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for apf530 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.