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Thrombopoietin Receptor Agonist

Romiplostim for Thrombocytopenia

Phase 2
Waitlist Available
Led By Cy Wilkins, MD
Research Sponsored by Memorial Sloan Kettering Cancer 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 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if regular injections of romiplostim can boost platelet counts in chemotherapy patients more effectively than waiting for natural recovery. The goal is to see if this treatment allows patients to continue chemotherapy without experiencing low platelet counts. Romiplostim has been shown to increase platelet counts and reduce the need for other treatments in patients with low platelet counts.

Eligible Conditions
  • Low Platelet Count

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Achievement of platelet counts of ≥ 100,000/mcL
Secondary study objectives
Assessment of potential toxicity

Side effects data

From 2014 Phase 4 trial • 169 Patients • NCT00907478
30%
Headache
24%
Nasopharyngitis
22%
Arthralgia
22%
Epistaxis
20%
Contusion
20%
Petechiae
19%
Diarrhoea
18%
Upper Respiratory Tract Infection
14%
Nausea
14%
Bronchitis
14%
Back Pain
14%
Cough
13%
Idiopathic Thrombocytopenic Purpura
12%
Gingival Bleeding
12%
Fatigue
12%
Pyrexia
11%
Vomiting
10%
Thrombocytopenia
10%
Pain In Extremity
10%
Oropharyngeal Pain
9%
Pruritus
9%
Haematoma
9%
Influenza
9%
Sinusitis
9%
Urinary Tract Infection
8%
Rash
8%
Mouth Haemorrhage
8%
Local Swelling
8%
Dizziness
8%
Insomnia
7%
Abdominal Pain
7%
Constipation
7%
Oedema Peripheral
7%
Pharyngitis
7%
Viral Infection
7%
Myalgia
6%
Abdominal Pain Upper
5%
Hypertension
5%
Anaemia
5%
Chest Pain
5%
Fall
5%
Laceration
5%
Musculoskeletal Pain
5%
Paraesthesia
5%
Rhinorrhoea
5%
Ecchymosis
4%
Iron Deficiency Anaemia
4%
Palpitations
4%
Vertigo
4%
Cataract
4%
Influenza Like Illness
4%
Pain
4%
Respiratory Tract Infection
4%
Procedural Pain
4%
Hypokalaemia
4%
Bone Pain
4%
Neck Pain
4%
Dyspnoea
4%
Alopecia
3%
Haemorrhoids
2%
Neutrophilia
2%
Tachycardia
2%
Abdominal Pain Lower
2%
Malaise
1%
Deep Vein Thrombosis
1%
Sensory Disturbance
1%
Peripheral Embolism
1%
Peripheral Ischaemia
1%
Haemorrhage
1%
Ischaemic Stroke
1%
Femur Fracture
1%
Cholecystitis
1%
Cholecystitis Acute
1%
Portal Vein Thrombosis
1%
Thrombosis
1%
Acute Abdomen
1%
Haemolysis
1%
Haemorrhagic Diathesis
1%
Neutropenia
1%
Atrial Fibrillation
1%
Atrial Flutter
1%
Cardiac Disorder
1%
Cardiac Failure
1%
Myocardial Infarction
1%
Goitre
1%
Conjunctival Haemorrhage
1%
Glaucoma
1%
Hyphaema
1%
Gastrointestinal Haemorrhage
1%
Gingival Disorder
1%
Melaena
1%
Rectal Haemorrhage
1%
Upper Gastrointestinal Haemorrhage
1%
Asthenia
1%
Abscess Jaw
1%
Cellulitis
1%
Endocarditis
1%
Fungal Sepsis
1%
Lobar Pneumonia
1%
Peritonitis
1%
Pneumonia
1%
Facial Bones Fracture
1%
Femoral Neck Fracture
1%
Injury
1%
Procedural Haemorrhage
1%
Subdural Haematoma
1%
Clostridium Test Positive
1%
Weight Decreased
1%
Dehydration
1%
Diabetes Mellitus Inadequate Control
1%
Hyperkalaemia
1%
Exostosis
1%
Osteoarthritis
1%
Endometrial Adenocarcinoma
1%
Plasma Cell Myeloma
1%
Prostate Cancer
1%
Uterine Leiomyoma
1%
Carotid Artery Stenosis
1%
Cerebral Haemorrhage
1%
Cerebrovascular Accident
1%
Complicated Migraine
1%
Spinal Claudication
1%
Syncope
1%
Completed Suicide
1%
Anuria
1%
Calculus Urethral
1%
Renal Failure Acute
1%
Adenomyosis
1%
Endometriosis
1%
Haemorrhagic Ovarian Cyst
1%
Menorrhagia
1%
Metrorrhagia
1%
Ovarian Cyst
1%
Vaginal Haemorrhage
1%
Pleural Effusion
1%
Pulmonary Embolism
1%
Pulmonary Haemorrhage
1%
Pulmonary Thrombosis
1%
Respiratory Failure
1%
Hyperhidrosis
1%
Lichenoid Keratosis
1%
Skin Disorder
1%
Knee Operation
1%
Tooth Extraction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall
Cohort 1
Cohort 2
Cohort 3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RomiplostimExperimental Treatment1 Intervention
All patients will begin weekly romiplostim at 2 mcg/kg, subcutaneously. The romiplostim dose will be titrated on weekly CBC/platelet counts. For titration purposes, the target platelet count is 150,000-200,000/mcL. Treatment can be held up to 16 days if a patient develops an intercurrent medical illness or symptom that is unrelated to study drug therapy. Treatment may be held up to 20 days if the patient unavailable for non- medical reasons, such as vacation or travel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
romiplostim
2016
Completed Phase 4
~250

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,778 Total Patients Enrolled
AmgenIndustry Sponsor
1,466 Previous Clinical Trials
1,401,436 Total Patients Enrolled
Cy Wilkins, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Romiplostim (Thrombopoietin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02052882 — Phase 2
Low Platelet Count Research Study Groups: Romiplostim
Low Platelet Count Clinical Trial 2023: Romiplostim Highlights & Side Effects. Trial Name: NCT02052882 — Phase 2
Romiplostim (Thrombopoietin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02052882 — Phase 2
~5 spots leftby Dec 2025
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