A Study of PEP503 With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With Head and Neck Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02901483|
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : August 31, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma||Drug: PEP503 Drug: Cisplatin Radiation: Radiotherapy||Phase 1 Phase 2|
- Phase 1b (dose escalation portion): To assess the safety profile and determine the Dose Limiting Toxicity (DLT) and to define the recommended volumes (doses) of PEP503.
- Phase 2 (expansion portion): To evaluate the anti-tumor activity in terms of the rate of locoregional control at one year and to evaluate the safety profile.
- Phase 1b: To characterize the body kinetic profile of PEP503.
- Phase 2: Objective tumor response, progression free survival rate at 1 year and pathological response (pR).
The target population is composed by patients who have pathologically confirmed squamous cell carcinoma of oral cavity with disease clinically staged as T4b who are not candidates for surgical resection or T3-4 who decline surgery or medical inoperable, without metastasis disease. ECOG performance status 0 or 1 and adequate bone marrow, renal, and hepatic function.
Dose limiting toxicity (DLT) - The DLTs are related to PEP503, injection procedure, or concurrent chemo radiation therapy and occur in the DLT evaluation period. The DLT evaluation period starts from the intratumor injection of PEP503 to 4 weeks after the completion of radiation treatment.
There are 4 levels (Level 1, Level 2, Level 3 and Level 4 correspond to 5%, 10%, 15% and 22% of the total baseline tumor volume, respectively) in this phase 1b study. PEP503 will be given at the fixed concentration of 53.3g/L. The starting volume of PEP503 to be injected is 5% (Level 1) of the tumor volume confirmed by MRI.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b/2 Study of PEP503 (Radioenhancer) With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With Head and Neck Cancer|
|Actual Study Start Date :||October 11, 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Phase 1b: There are 4 levels (5%, 10%, 15% and 22%) in this phase 1b study. Only primary tumor will receive PEP503 implementation via intratumor injection. A 3 + 3 dose escalation study design will be adopted in this phase to identify the recommended intratumor injection volumes of PEP503.
Phase 2: The recommended volume identified from phase 1b will be applied in phase 2 for both primary tumor and ≥ 3 cm lymph node lesions.
PEP503 will be administered by intratumoral route as slow injection
Other Name: NBTXR3
The concurrent chemoradiotherapy. Weekly cisplatin 40 mg/m2 with a minimum of accumulated 200 mg/m2 during the 7~8 weeks' radiation period.
Patients will receive 70-72 Gy, 2-2.12 Gy/fraction over 7~8 weeks.
- Phase 1: Determination of the Recommended doses and the Dose Limiting Toxicities (DLT) [ Time Frame: 24 months ]To determine the Recommended volumes and the Dose Limiting Toxicities (DLT) of PEP503 administered as intratumor injection, activated by CCRT
- Phase 2: The rate of locoregional control at one year [ Time Frame: 24 months ]To evaluate the rate of locoregional control at one year after PEP503 intratumor injection
- Phase1 and 2: Evaluation of Safety profile of PEP503 [ Time Frame: 24 months ]Safety of PEP503, as intratumor injection schedule, activated by CCRT will be assessed in terms of incidence and severity of clinical and laboratory Adverse Events by NCI-CTCAE version 4.0
- Phase 1: The body kinetic profile of PEP503 [ Time Frame: 24 months ]To characterize the body kinetics on Date of injection(DINJ) of PEP503 administered by intratumor injection before CCRT
- Phase 2: Evaluation of objective tumor response as per Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 24 months ]To evaluate the objective tumor rate by using RECIST v1.1 after intratumor injection schedule, activated by CCRT
- Phase 2: Pathological response (pR) [ Time Frame: 24 months ]If patients receive tumor and/or neck lymph node dissection after treatment, to assess according to the evidence of viable tumor cell
- Phase 2: Evalution of progression free survival rate at 1 year [ Time Frame: 24 months ]To evaluate the progression free survival rate at 1 year after the intratumor injection of PEP503
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901483
|Contact: Weiche Yu||+886 2 email@example.com|
|Keelung Chang Gung Memorial Hospital (Lovers Lake Branch)||Recruiting|
|Principal Investigator:||Cheng-Hsu Wang, M.D.||Keelung Chang Gung Memeorial Hospital (Lovers Lake Branch)|