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Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy

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: NCT03769506
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Rakuten Medical, Inc.

Study Description
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Brief Summary:
This study will evaluate the efficacy and safety of ASP-1929 Photoimmunotherapy as a monotherapy 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 or disease Intervention/treatment Phase
Head and Neck Cancer Combination Product: ASP-1929 Drug: Physician's Choice SOC Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Standard of Care for Locoregional Recurrent Head/Neck Squamous Cell Carcinoma in Patients Who Have Failed After at Least Two Lines of Therapy
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2021
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 24 months ]
    Time to progression of disease

  2. Overall survival [ Time Frame: 24 months ]
    Duration of survival between the two treatment arms


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Contacts and Locations
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Information from the National Library of Medicine

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): NCT03769506


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

Locations
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Sponsors and Collaborators
Rakuten Medical, Inc.
Investigators
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Study Director: Grace Mann Rakuten Medical, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rakuten Medical, Inc.
ClinicalTrials.gov Identifier: NCT03769506    
Other Study ID Numbers: ASP-1929-301
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Rakuten Medical, Inc.:
Rakuten Medical
ASP-1929
PIT
photoimmunotherapy
 HNC
HNSCC
head and neck
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms