← Back to Search

Taxane

Selinexor for Non-Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up each 21 day cycle for 2 years
Awards & highlights

Study Summary

This trial is testing selinexor as a possible treatment for KRAS mutant lung cancer in patients who have already tried other treatments.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~each 21 day cycle for 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and each 21 day cycle for 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD)
Secondary outcome measures
Tumor size will be assessed using the RECIST v1.1

Side effects data

From 2017 Phase 2 trial • 116 Patients • NCT02025985
88%
Nausea
72%
Vomiting
52%
Anaemia
48%
Thrombocytopenia
48%
Fatigue
48%
Decreased Appetite
48%
Weight Decreased
28%
Dizziness
28%
Insomnia
28%
Abdominal Pain
28%
Asthenia
28%
Dysgeusia
28%
Vision Blurred
28%
Constipation
24%
Dyspnoea
24%
Hypokalaemia
24%
Diarrhoea
16%
Hyponatraemia
16%
Urinary Tract Infection
12%
Cough
12%
Pulmonary Embolism
12%
Pyrexia
12%
Oedema Peripheral
12%
Hypomagnesaemia
12%
Anxiety
12%
Stomatitis
12%
Headache
12%
Abdominal Distension
12%
Malaise
8%
Device Occlusion
8%
Cystitis
8%
Laryngitis
8%
Back Pain
8%
Hydronephrosis
8%
Ascites
8%
Ileus
8%
Dehydration
8%
Hyperglycaemia
8%
Pleural Effusion
8%
Face Oedema
8%
Somnolence
8%
Visual Impairment
8%
Muscular Weakness
8%
Agitation
8%
Hypotension
8%
Oedema
8%
Neutropenia
8%
Lung Infection
4%
Dysuria
4%
Haematuria
4%
Confusional State
4%
Alopecia
4%
Vertigo
4%
Hypertension
4%
Vaginal Haemorrhage
4%
Pneumothorax
4%
Embolism
4%
Dry Mouth
4%
Peripheral Sensory Neuropathy
4%
Pneumonia
4%
Arthralgia
4%
Muscle Spasms
4%
Depression
4%
Hallucination
4%
Contusion
4%
Device Related Infection
4%
Acute Kidney Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW
Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW

Trial Design

1Treatment groups
Experimental Treatment
Group I: Selinexor Monotherapy and in Combination with DocetaxelExperimental Treatment2 Interventions
For the selinexor monotherapy cohort, 6 patients each will be treated in two dosing cohorts (weekly and biweekly). Selinexor once weekly oral (40mg, 60mg, 80mg) OR Selinexor twice weekly oral (60mg, 40mg, 60mg weekly). Selinexor will be administered once weekly starting one week before chemotherapy initiation in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Selinexor dose escalation: 60, 80, 40 mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Selinexor
2020
Completed Phase 2
~1360

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,038 Previous Clinical Trials
1,046,731 Total Patients Enrolled
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,796 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study currently enrolling new participants?

"As per clinicaltrials.gov, this investigation is no longer open for recruitment. First posted in March 2018 and last updated November 2022, the trial has closed its doors to new applicants; however 2315 other experiments are currently enrolling patients right now."

Answered by AI

Have any other investigations explored the potential of Selinexor?

"At the moment, Selinexor has 366 studies underway with 130 trials in Phase 3. While Saint Louis is a hub for research on this drug, there are 23292 centres worldwide that have running investigations of Selinexor."

Answered by AI

What maladies is Selinexor employed to combat?

"Selinexor is regularly used to treat cancerous tumours, and in some cases it can be prescribed to manage specific conditions such as sarcoma, refractory multiple myeloma, or advanced directives."

Answered by AI

How many individuals have been recruited to participate in this experiment?

"Unfortunately, recruitment for this trial has been suspended. It was first advertised on March 22nd 2018 and the last update took place November 15th 2022. Those seeking alternative clinical trials can look into 1949 studies recruiting patients with carcinoma non-small cell lung cancer or 366 studies that require participants to take Selinexor."

Answered by AI

In what geographic locations is this clinical research initiative being conducted?

"This particular medical trial is recruiting from University of Washington-Seattle Cancer Care Alliance in Seattle, the University of Pittsburgh Medical Center-Hillman Cancer Centre in Pennsylvania, and University of Texas Southwestern Medical Centre in Dallas. Additionally, there are 5 additional sites taking part."

Answered by AI
~6 spots leftby Mar 2025