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Purpose

A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


Patients must have histologically confirmed locoregional persistent, recurrent or second
primary squamous cell carcinoma of the head and neck, not amenable to curative treatment.

Patients must have failed or progressed on or after at least 2 lines of therapy, one of
which must be prior platinum-based chemotherapy. (Treatments such as surgery followed by
chemotherapy and radiation, or surgery and radiation, or radiation, or surgery is
considered one line of therapy).

Patients must not have a history of significant reactions to cetuximab, not actively
undergoing treatment of or have a diagnosis of an active cancer other than nonmelanoma skin
cancer or HNSCC.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
ASP-1929
  • Combination Product: ASP-1929
    Use of ASP-1929 PIT therapy
Active Comparator
Physician's Choice SOC
docetaxel, cetuximab, methotrexate, paclitaxel
  • Drug: Physician's Choice SOC
    docetaxel, cetuximab, methotrexate, or paclitaxel

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536

More Details

NCT ID
NCT03769506
Status
Recruiting
Sponsor
Rakuten Medical, Inc.

Study Contact

Jeannie Hou
650-622-7508
Jeannie.hou@rakuten-med.com

Detailed Description

The study will have an Experimental Arm and a Control Arm.

Experimental Arm:

Patients may receive repeated ASP-1929 PIT interventions for a period of up to 12 months after randomization until the patient has complete remission, progressive disease that is no longer amendable to study treatment, patient experiences intolerable side effects, or patient discontinues study treatment.

Control Arm:

Patients may be treated with physician's choice SOC until the patient has progressive disease, patient experiences intolerable side effects, or patient discontinues study treatment.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.