West Cancer Center

SUPPORTIVE CARE: CINV; HEC; "C2013-01"

A Phase 3 Clinical Study Protocol: A prospective, randomized, placebo-controlled, double-blind, multicenter, phase 3 study of APF530 500mg SC, fosaprepitant 150mg IV, and dexamethasone vs. ondansetron 0.15 mk/kg IV, fosaprepitant 150 mg IV, and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy

Title

Heron C2013-01

Study Title

Site Link

NCT02160494

Malignancy

x- breast, head and neck (oropharynx, larynx, hypopharynx,oral cavity), lung, sarcoma

Stage

N/A

Disease Setting

Malignant Disease

Line Of Therapy

N/A

Investigational Agent

APF530 (Granisetron)

Drug Class

Serotonin 5-HT3 receptor antagonist

Lee Schwartzberg, MD

Sponsor

Heron Therapeutics

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT02106494

Key Eligibility Criteria Details

18-75 years old
Malignant disease

Plan to get HEC (highly emetogenic chemotherapy) including any of following:
AC
Cisplatin (>50mg/m2)
ECOG PS 0-1
Adequate BM, kidney, liver fxn
No EKG interval abnormalities, or clin sig cardiac dz
No multi-day chemotherapy
No benzos within 1 day prior to therapy
No 5-HT3 antagonists within 7 days
No CNS disease

Objective

Primary- Delayed phase CR rate (defined as no emesis and no use of rescue medications); Secondary- acute-phase CR, overall CR, complete control rates, total response rate

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Any

Dosing Frequency

APF530 500mg SC, fosaprepitant 150mg IV, and dex 12mg IV day 1 of cycle 1 only

Control Agents

ondansetron 0.15mg/kg IV + placebo SC

Study Protocol

Randomized

Yes