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

NCT02901483 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-01-11

No results posted yet for this study

Summary

It's a prospective, open-label, single arm, nonrandomized study of PEP503 in head and neck squamous cell carcinoma (HNSCC) patients.

* Escalation portion (Phase 1b):A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended intratumor injection volumes of PEP503.
* Expansion portion (Phase 2): Following confirmation of the recommended volumes, 18 additional patients will be enrolled at the recommended volume level to evaluate for safety and efficacy.

Conditions

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.

Sponsors & Collaborators

  • PharmaEngine

    lead INDUSTRY

Principal Investigators

  • Cheng-Hsu Wang, M.D. · Keelung Chang Gung Memeorial Hospital (Lovers Lake Branch)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-11
Primary Completion
2020-08-17
Completion
2020-08-17

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02901483 on ClinicalTrials.gov