Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas

NCT02213133 | Terminated Phase 2 Results

• 1 other identifier: KCP-330-006
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 18

Brief Summary

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.

Conditions

Squamous Cell Carcinoma

Keywords

Squamous; SCC; Carcinoma; KPT-330; SINE; Selinexor; Karyopharm; Karyopharm Therapeutics; Lung; Head; Neck; Esophageal

Outcome Measures

Primary Outcomes (1)

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

  DCR was defined as the best overall response of complete response (CR), partial response (PR), or stable disease (SD). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Participant response was evaluated by physical examinations and computed tomography (CT)/Magnetic Resonance Imaging (MRI) (or optional positron emission tomography \[PET\]/CT) and assessed by RECIST 1.1 criteria.

  up to 14.6 months

Secondary Outcomes (2)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  From the first administration of study drug up to 30 days follow-up (up to 14.6 months)

• Number of Participants With Treatment-emergent Adverse Events by Severity: Clinical Terminology Categories for Adverse Events (CTCAE) Grading Scale

  From the first administration of study drug up to 30 days follow-up (up to 14.6 months)

Study Arms (3)

Cohort 1: Head and Neck-SCC

EXPERIMENTAL

Participants with advanced squamous cell carcinoma (SCC) of head and neck, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 milligram (mg) selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets less than \[\<\] 100\*10\^9 per litre \[/L\]), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.

Drug: Selinexor (KPT-330)

Cohort 2: Lungs-SCC

EXPERIMENTAL

Participants with advanced SCC of lungs, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets \<100\*10\^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.

Drug: Selinexor (KPT-330)

Cohort 3: Esophagus-SCC

EXPERIMENTAL

Participants with advanced SCC of esophagus, who had relapsed or had metastasis following chemotherapy, received a fixed dose of 60 mg selinexor oral tablets twice weekly on Days 1 and 3 of a 28-day cycle (8 doses in 4 weeks) until disease progression or development of unacceptable toxicities. After completion of Cycle 2, for participants with absence of any grade 2 toxicity and thrombocytopenia (platelets \<100\*10\^9/L), dose may be increased to 80 mg selinexor oral tablets twice weekly as assessed by investigator in a 28-day cycle until disease progression or development of unacceptable toxicities.

Drug: Selinexor (KPT-330)

Interventions

Selinexor (KPT-330) DRUG

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.

Also known as: KPT-330

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• confirmed SCC of the head and neck, lung, or esophagus
• to 2 prior therapies
• measurable disease at screening and documented progression within the past 6 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Karyopharm Therapeutics Inc: lead

Study Sites (18)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Dana-Farber Cancer Institute / Harvard University

Boston, Massachusetts, 02215, United States

Location

Metrowest Medical Center

Framingham, Massachusetts, 01702, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Washington University School of Medicine / Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029-6574, United States

Location

Herbert Irving Comprehensive Cancer Center / Columbia University

New York, New York, 10032, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Sarah Cannon Research Institute - Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Vanderbilt-Ingram Cancer Center / Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Mary Crowley Cancer Research Center / Texas Oncology

Dallas, Texas, 75201, United States

Location

University of Washington

Seattle, Washington, 63110, United States

Location

Princess Margaret Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Carcinoma

Interventions

selinexor

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Limitations and Caveats

The study was terminated due to enrollment challenges and availability of other options for lung cancer participants. The termination was not a consequence of any safety concern.

Results Point of Contact

• Title: Jatin Shah, MD
• Organization: Karyopharm Therapeutics Inc.

jshah@karyopharm.com

(617) 658-0600

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 11, 2014
• Study Start: September 22, 2014
• Primary Completion: December 10, 2015
• Study Completion: December 10, 2015
• Last Updated: January 26, 2023
• Results First Posted: December 7, 2020

Record last verified: 2023-01

Locations

CA (1); US (17)