Clinical trial

A Phase 2, Open-Label Study of the Safety and Efficacy of the Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck, Lung, or Esophagus

Name

KCP-330-006

Description

Open-label, multi-center, single-arm, Phase 2 study of oral selinexor in patients with SCC of the head and neck (HN-SCC; Cohort 1), lung (L-SCC; Cohort 2), or esophagus (E-SCC; Cohort 3) who have relapsed or have metastasis following chemotherapy.

Trial arms

Trial start

2014-09-22

Estimated PCD

2015-12-10

Trial end

2015-12-10

Status

Terminated

Phase

Early phase I

Treatment

Selinexor (KPT-330)

Oral tablet or suspension at 60, 80, 100 or 120 mg per patient-specific body surface area category. Dosing will occur twice weekly in 28-days cycle.

Arms:

Cohort 1: Head and Neck-SCC, Cohort 2: Lungs-SCC, Cohort 3: Esophagus-SCC

Other names:

KPT-330

Size

Primary endpoint

Percentage of Participants With Disease Control Rate (DCR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

up to 14.6 months

Eligibility criteria

Inclusion Criteria: * 18 years of age or older * confirmed SCC of the head and neck, lung, or esophagus * 1 to 2 prior therapies * measurable disease at screening and documented progression within the past 6 weeks Exclusion Criteria: * patients requiring total parenteral nutrition * unstable cardiovascular function * substantially impaired gastrointestinal function * Symptomatic brain metastases * another malignancy within 3 years except adequately treated in situ carcinoma of any type, basal or non-melanomatous skin cancer

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}

Updated at

2023-01-26

1 organization

1 product

1 indication

Product

Selinexor

Indication

Squamous Cell Carcinoma

Organization

Karyopharm Therapeutics