A Study of PEP503 With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With Head and Neck Cancer

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 11, 2016

Primary Completion Date

August 17, 2020

Study Completion Date

August 17, 2020

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

PEP503

PEP503 will be administered by intratumoral route as slow injection

DRUG

Cisplatin

The concurrent chemoradiotherapy. Weekly cisplatin 40 mg/m2 or tri-weekly 100 mg/m2, depending on which dose level patients are in, with a minimum of accumulated 200 mg/m2 during the 7\~8 weeks' radiation period.

RADIATION

Radiotherapy

Patients will receive 70-72 Gy, 2-2.12 Gy/fraction over 7\~8 weeks.

Trial Locations (1)

Unknown

Keelung Chang Gung Memorial Hospital (Lovers Lake Branch), Keelung

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PharmaEngine

INDUSTRY

NCT02901483 - A Study of PEP503 With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With Head and Neck Cancer | Biotech Hunter | Biotech Hunter