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Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas (STARRS)

Primary Purpose

Squamous Cell Carcinoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Selinexor (KPT-330)
Sponsored by
Karyopharm Therapeutics Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma focused on measuring Squamous, SCC, Carcinoma, KPT-330, SINE, Selinexor, Karyopharm, Karyopharm Therapeutics, Lung, Head, Neck, Esophageal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Cancer Center
  • Lee Moffitt Cancer Center and Research Institute
  • Northwestern University
  • Tufts Medical Center
  • Dana-Farber Cancer Institute / Harvard University
  • Metrowest Medical Center
  • Karmanos Cancer Institute
  • Washington University School of Medicine / Washington University in St. Louis
  • Hackensack University Medical Center
  • Icahn School of Medicine at Mount Sinai
  • Herbert Irving Comprehensive Cancer Center / Columbia University
  • Gabrail Cancer Center
  • Oregon Health and Science University
  • Sarah Cannon Research Institute - Tennessee Oncology
  • Vanderbilt-Ingram Cancer Center / Vanderbilt University
  • Mary Crowley Cancer Research Center / Texas Oncology
  • University of Washington
  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1: Head and Neck-SCC

Cohort 2: Lungs-SCC

Cohort 3: Esophagus-SCC

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was defined as any unfavorable sign and unintended sign (including abnormal laboratory finding), symptom, or disease temporarily associated with the use of the study drug, whether or not related to study drug. An SAE was defined as any untoward medical occurrence that occurs at any dose (including after informed consent was signed and prior to dosing) that resulted in death, was life-threatening (participant was at immediate risk of death from event), required in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect, and important medical events. A TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after first dose of treatment through 30 days following last dose of study treatment, or any event considered drug-related by investigator through end of study.
Number of Participants With Treatment-emergent Adverse Events by Severity: Clinical Terminology Categories for Adverse Events (CTCAE) Grading Scale
AE:Any unfavorable sign and unintended sign,symptom, or disease temporarily associated with use of study drug, whether or not related to it. SAE:Any untoward medical occurrence that occurs at any dose (after informed consent was signed, prior dosing) that resulted in death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and important medical events. TEAE:Any AE with onset or worsening of existing condition on or after first dose through 30 days following last dose of study drug, or any event considered drug-related by investigator through end of study. Severity(Grades 1 to 5) of each AE was categorized as either mild=1(transient,does not interfere with daily activities), moderate=2(low level of inconvenience or concern,interfere with daily activities), severe=3(interrupt usual daily activities), life threatening=4 or fatal=5, higher grade reported worst outcome.

Full Information

First Posted
August 7, 2014
Last Updated
January 24, 2023
Sponsor
Karyopharm Therapeutics Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02213133
Brief Title
Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas
Acronym
STARRS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to enrollment challenges and availability of other options for lung cancer patients. The termination is not a consequence of any safety concern.
Study Start Date
September 22, 2014 (Actual)
Primary Completion Date
December 10, 2015 (Actual)
Study Completion Date
December 10, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karyopharm Therapeutics Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a multicenter, open-label, single-arm Phase 2 study of the SINE selinexor given orally to patients diagnosed with advanced SCC of the head and neck, lung, or esophagus who have experienced relapse and/or metastasis following multiple prior chemotherapy treatments (<2 lines of therapy). Patients will receive fixed doses of selinexor tablets twice weekly in 28-day cycles. Patients may continue from one cycle to the next without interruption as along as all criteria are met and no reason for discontinuation occurs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma
Keywords
Squamous, SCC, Carcinoma, KPT-330, SINE, Selinexor, Karyopharm, Karyopharm Therapeutics, Lung, Head, Neck, Esophageal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Head and Neck-SCC
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2: Lungs-SCC
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 3: Esophagus-SCC
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Selinexor (KPT-330)
Other Intervention Name(s)
KPT-330
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Disease Control Rate (DCR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Description
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.
Time Frame
up to 14.6 months
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
An adverse event (AE) was defined as any unfavorable sign and unintended sign (including abnormal laboratory finding), symptom, or disease temporarily associated with the use of the study drug, whether or not related to study drug. An SAE was defined as any untoward medical occurrence that occurs at any dose (including after informed consent was signed and prior to dosing) that resulted in death, was life-threatening (participant was at immediate risk of death from event), required in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect, and important medical events. A TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after first dose of treatment through 30 days following last dose of study treatment, or any event considered drug-related by investigator through end of study.
Time Frame
From the first administration of study drug up to 30 days follow-up (up to 14.6 months)
Title
Number of Participants With Treatment-emergent Adverse Events by Severity: Clinical Terminology Categories for Adverse Events (CTCAE) Grading Scale
Description
AE:Any unfavorable sign and unintended sign,symptom, or disease temporarily associated with use of study drug, whether or not related to it. SAE:Any untoward medical occurrence that occurs at any dose (after informed consent was signed, prior dosing) that resulted in death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, and important medical events. TEAE:Any AE with onset or worsening of existing condition on or after first dose through 30 days following last dose of study drug, or any event considered drug-related by investigator through end of study. Severity(Grades 1 to 5) of each AE was categorized as either mild=1(transient,does not interfere with daily activities), moderate=2(low level of inconvenience or concern,interfere with daily activities), severe=3(interrupt usual daily activities), life threatening=4 or fatal=5, higher grade reported worst outcome.
Time Frame
From the first administration of study drug up to 30 days follow-up (up to 14.6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Dana-Farber Cancer Institute / Harvard University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Metrowest Medical Center
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University School of Medicine / Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center / Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Sarah Cannon Research Institute - Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center / Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Mary Crowley Cancer Research Center / Texas Oncology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
63110
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas

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