Clinical trial · Interventional
Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to enrollment challenges and availability of other options for lung cancer patients. The termination is not a consequence of any safety concern.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Selinexor (KPT-330) | Drug | Selinexor | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1: Head and Neck-SCC
- 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.
- interventionNames
- Drug: Selinexor (KPT-330)
- type
- EXPERIMENTAL
- label
- Cohort 2: Lungs-SCC
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available