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Corticosteroid

Selinexor for Amyloidosis (STARR Trial)

Phase < 1
Waitlist Available
Led By Cara Rosenbaum, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of primary AL amyloidosis
Relapsed and/or refractory AL amyloidosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study (approximately 3 years)
Awards & highlights

STARR Trial Summary

This study is evaluating whether a drug called Selinexor and a drug called Dexamethasone can be used to treat AL amyloidosis.

Eligible Conditions
  • Amyloidosis
  • AL Amyloidosis

STARR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

STARR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study (approximately 3 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study (approximately 3 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
Compare number of dose limiting toxicity (DLT) occurence to measure safety and toxicity
Secondary outcome measures
Compare Hematologic Overall Response Rate (ORR)
Duration of hematologic response
Duration of organ response
+14 more

Side effects data

From 2017 Phase 2 trial • 116 Patients • NCT02025985
72%
Weight Decreased
68%
Nausea
60%
Fatigue
56%
Anaemia
52%
Thrombocytopenia
48%
Decreased Appetite
44%
Dysgeusia
44%
Vomiting
24%
Dyspnoea
24%
Diarrhoea
24%
Dizziness
24%
Constipation
20%
Insomnia
20%
Asthenia
20%
Vision Blurred
16%
Dysuria
16%
Pyrexia
16%
Back Pain
16%
Pollakiuria
12%
Cough
12%
Peripheral Sensory Neuropathy
12%
Headache
12%
Haematuria
12%
Hypokalaemia
12%
Nasopharyngitis
12%
Abdominal Pain
12%
Musculoskeletal Chest Pain
12%
Hypomagnesaemia
12%
Anxiety
8%
Malaise
8%
Arthralgia
8%
Device Occlusion
8%
Confusional State
8%
Hallucination
8%
Oedema Peripheral
8%
Urinary Tract Infection
8%
Depression
8%
Abdominal Distension
8%
Abdominal Pain Upper
8%
Face Oedema
8%
Hyponatraemia
8%
Paraesthesia
8%
Night Sweats
8%
Hot Flush
8%
Vaginal Haemorrhage
4%
Haematemesis
4%
Anal Haemorrhage
4%
Rectal Haemorrhage
4%
Urinary Retention
4%
Muscular Weakness
4%
Ear Discomfort
4%
Visual Impairment
4%
Vertigo
4%
Renal Failure
4%
Lung Infection
4%
Dyspepsia
4%
Cystitis Noninfective
4%
Stomatitis
4%
Dry Mouth
4%
Hyperglycaemia
4%
Hyperkalaemia
4%
Bronchitis
4%
Pulmonary Embolism
4%
Hypertension
4%
Bacteraemia
4%
Cystitis
4%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Cohort C-Cervical Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 2: Cohort A-Ovarian Carcinoma Schedule 2: Selinexor up to 60 mg/m^2 QW
Part 2: Cohort A-Ovarian Carcinoma Schedule 1: Selinexor up to 50 mg/m^2 BIW
Part 1: Cohort B-Endometrial Carcinoma: Selinexor up to 60 mg/m^2 BIW
Part 1: Cohort A-Ovarian Carcinoma: Selinexor up to 60 mg/m^2 BIW

STARR Trial Design

1Treatment groups
Experimental Treatment
Group I: selinexor/ dexamethasone (Sd)Experimental Treatment2 Interventions
Selinexor • 60mg PO once weekly on days 1, 8, 15, 22 until disease progression or toxicity Dexamethasone • 20 mg PO administered 30-60 minutes prior to selinexor on days 1, 2, 8, 9, 15, 16, 22, 23
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,330,564 Total Patients Enrolled
2 Trials studying Amyloidosis
37 Patients Enrolled for Amyloidosis
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,579 Total Patients Enrolled
1 Trials studying Amyloidosis
35 Patients Enrolled for Amyloidosis
Cara Rosenbaum, MDPrincipal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
61 Total Patients Enrolled
1 Trials studying Amyloidosis
21 Patients Enrolled for Amyloidosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease
2021. "Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04984330.
~0 spots leftby Apr 2025
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