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Head and Neck Squamous Cell CarcinomaPhase 1/2NCT02901483

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

A Phase 1/2 study testing PEP503, Cisplatin and Radiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by PharmaEngine at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
PEP503, Cisplatin and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteTaiwan
Study dates
11 Oct 2016to 17 Aug 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed squamous cell carcinoma (SCC) of oral cavity, oropharynx, hypopharynx, or larynx
  • Locally advanced or recurrent disease of: Oral Cavity:T4b, N any, who are not candidates for surgical resection; or T3-4, N any, who decline surgery or medical inoperable; OR Oropharynx, hypopharynx, or larynx: T3-4, N any
  • No evidence of distant metastatic disease, as determined by a negative PET scan or CT scan
  • ECOG Performance Status 0 or 1
  • Adequate function of bone marrow, kidney and liver:
  • White Blood Cell (WBC) ≥ 3.0 x 109/l
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  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/l
  • Platelet count ≥ 100 x 109/l
  • Hemoglobin ≥ 9.0 g/dL
  • Creatinine within normal range, for dose level with tri-weekly cisplatin, estimated GFR ≥ 60 mL/min/1.73m2 or CrCl ≥ mL/min is also required
  • AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN and Alkaline phosphatase (ALP) ≤ 2.5 x ULN
  • Bilirubin ≤ 1.5 x ULN
  • 20 years of age or older
  • All female patients of childbearing potential must have negative urine pregnancy test within 7 days prior to study treatment with PEP503. Fertile patients must agree to use effective contraception during the study

Who cannot join

  • Tumor ulceration combined with vascular risks
  • Prior radiotherapy to any area within the planned radiotherapy field
  • Uncontrolled intercurrent illness
  • Concurrent treatment with any other anticancer therapy
  • Participation in any investigational drug study within 4 weeks
  • Prior or concurrent non-head and neck malignancies, excluding adequately treated basal or squamous cell cancer of the skin, and in situ cervical cancer, and any other cancer from which the subject has been cancer free for 5 years
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  • Patients unable to comply with scheduled visits and other study procedures.
  • Preexisting neuropathy ≥ Grade 2 (CTCAE)
  • Pre-existing hearing impairment > Grade 2 (CTCAE) for patients receiving cisplatin 100 mg/m2
  • History of allergic reaction to platinum product

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Keelung Chang Gung Memorial Hospital (Lovers Lake Branch)

    Keelung

Other trials in Taiwan

About this study

Official title: A Phase 1b/2 Study of PEP503 (Radioenhancer) With Radiotherapy in Combination With Concurrent Chemotherapy for Patients With Head and Neck Cancer

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.
Read the detailed description

Primary Objectives:

  • 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.

Secondary Objectives:

  • 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, or oropharynx, hypopharynx, or larynx with disease clinical staged as T3-4, 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 6 levels (Level 1, Level 2, Level 3, Level 4, Level 3a and Level 5) 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.

Being tested
PEP503, Cisplatin, Radiotherapy
Keywords
Head and Neck
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEP503Drug

    Also called NBTXR3

    PEP503 will be administered by intratumoral route as slow injection

  • CisplatinDrug

    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.

  • RadiotherapyRadiation

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

Study groups in NCT02901483
Study groupRoleWhat they receive
PEP503+Cisplatin+RadiotheraphyExperimentalPhase 1b: There are 6 levels (L1- 5% + 40mg/m2 weekly cisplatin, L2- 10% + 40mg/m2 weekly cisplatin, L3- 15% + 40mg/m2 weekly cisplatin, L4-22% + 100mg/m2 tri-weekly cisplatin, L3a- 15% + 100mg/m2 tri-weekly cisplatin, and L5- 33% + 100mg/m2 tri-weekly cisplatin) 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.
Receives: Drug: PEP503; Drug: Cisplatin; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Determination of the Recommended doses and the Dose Limiting Toxicities (DLT)

    To determine the Recommended volumes and the Dose Limiting Toxicities (DLT) of PEP503 administered as intratumor injection, activated by CCRT

    Measured: 24 months

  2. Phase 2: The rate of locoregional control at one year

    To evaluate the rate of locoregional control at one year after PEP503 intratumor injection

    Measured: 24 months

  3. Phase1 and 2: Evaluation of Safety profile of PEP503

    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

    Measured: 24 months

Secondary outcomes (4)

  1. Phase 1: The body kinetic profile of PEP503

    To characterize the body kinetics on Date of injection(DINJ) of PEP503 administered by intratumor injection before CCRT

    Measured: 24 months

  2. Phase 2: Evaluation of objective tumor response as per Response Evaluation Criteria in Solid Tumors (RECIST)

    To evaluate the objective tumor rate by using RECIST v1.1 after intratumor injection schedule, activated by CCRT

    Measured: 24 months

  3. Phase 2: Pathological response (pR)

    If patients receive tumor and/or neck lymph node dissection after treatment, to assess according to the evidence of viable tumor cell

    Measured: 24 months

  4. Phase 2: Evalution of progression free survival rate at 1 year

    To evaluate the progression free survival rate at 1 year after the intratumor injection of PEP503

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2016 (estimated)
  2. Study start11 Oct 2016
  3. Primary completion17 Aug 2020
  4. Study completion17 Aug 2020

Why it stopped: bussiness reason

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02901483
Sponsor's protocol ID
PEP503-HN-1002
Status last verified
Dec 2021
First submitted
31 Aug 2016
Last updated
11 Jan 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PEP503, Cisplatin and Radiotherapy in people with Head and Neck Squamous Cell Carcinoma, run by PharmaEngine at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: bussiness reason). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Determination of the Recommended doses and the Dose Limiting Toxicities (DLT) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02901483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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