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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
Patients (18 years of age or greater) with active non-hematological cancer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is to see if a drug called romiplostim will help raise a patient's platelet counts back to a normal range faster than if the patient just waited for their platelets to improve on their own. The trial will also see if romiplostim will allow the patient to have at least 2 more cycles of chemotherapy without having low platelet counts again.

Eligible Conditions
  • Thrombocytopenia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are 18 years or older and have a type of cancer that is currently active and not related to blood.

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

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

Side effects data

From 2014 Phase 4 trial • 169 Patients • NCT00907478
24%
Headache
22%
Upper Respiratory Tract Infection
18%
Petechiae
18%
Epistaxis
16%
Arthralgia
16%
Idiopathic Thrombocytopenic Purpura
16%
Thrombocytopenia
14%
Diarrhoea
12%
Pyrexia
12%
Fatigue
12%
Nasopharyngitis
12%
Contusion
12%
Mouth Haemorrhage
12%
Nausea
10%
Local Swelling
10%
Back Pain
10%
Vomiting
8%
Urinary Tract Infection
8%
Oedema Peripheral
8%
Pain In Extremity
8%
Dizziness
8%
Cough
8%
Dyspnoea
6%
Neutrophilia
6%
Rash
6%
Tachycardia
6%
Bronchitis
6%
Sinusitis
6%
Cataract
6%
Constipation
6%
Gingival Bleeding
6%
Insomnia
4%
Anaemia
4%
Abdominal Pain Upper
4%
Respiratory Tract Infection
4%
Ecchymosis
4%
Fall
4%
Hypokalaemia
4%
Cerebrovascular Accident
4%
Iron Deficiency Anaemia
4%
Abdominal Pain
4%
Neck Pain
4%
Haematoma
2%
Gingival Disorder
2%
Subdural Haematoma
2%
Viral Infection
2%
Myalgia
2%
Cardiac Disorder
2%
Cellulitis
2%
Lobar Pneumonia
2%
Adenomyosis
2%
Endometriosis
2%
Metrorrhagia
2%
Tooth Extraction
2%
Pharyngitis
2%
Endocarditis
2%
Fungal Sepsis
2%
Uterine Leiomyoma
2%
Palpitations
2%
Influenza
2%
Laceration
2%
Bone Pain
2%
Glaucoma
2%
Hyphaema
2%
Rectal Haemorrhage
2%
Asthenia
2%
Portal Vein Thrombosis
2%
Femur Fracture
2%
Clostridium Test Positive
2%
Weight Decreased
2%
Dehydration
2%
Prostate Cancer
2%
Cerebral Haemorrhage
2%
Haemorrhagic Ovarian Cyst
2%
Menorrhagia
2%
Pulmonary Haemorrhage
2%
Pulmonary Thrombosis
2%
Musculoskeletal Pain
2%
Vertigo
2%
Chest Pain
2%
Paraesthesia
2%
Pruritus
2%
Oropharyngeal Pain
2%
Rhinorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1
Cohort 2
Cohort 3
Overall

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
1,928 Previous Clinical Trials
591,748 Total Patients Enrolled
5 Trials studying Thrombocytopenia
51 Patients Enrolled for Thrombocytopenia
AmgenIndustry Sponsor
1,355 Previous Clinical Trials
1,384,011 Total Patients Enrolled
30 Trials studying Thrombocytopenia
4,299 Patients Enrolled for Thrombocytopenia
Cy Wilkins, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Romiplostim (Thrombopoietin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02052882 — Phase 2
Thrombocytopenia Research Study Groups: Romiplostim
Thrombocytopenia 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

Frequently Asked Questions

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

Does this new research on romiplostim build off of other scientific work?

"romiplostim was first investigated in 2014 at Memorial Sloan Kettering Bergen. 41 studies have completed since then. As of now, 9 clinical trials are ongoing with most of them based in New york City."

Answered by AI

Are participants being accepted into this experiment at this time?

"No, this study is not currently recruiting patients according to the most recent update on clinicaltrials.gov. The site reports that the study was first posted on 1/30/2014 and last updated on 2/1/2022. However, there are 132 other trials looking for participants right now."

Answered by AI

Has this type of clinical trial been done before?

"There have been a total of 9 ongoing studies for romiplostim since 2014. Earlier trials, such as the one sponsored by Amgen, completed their Phase 2 drug approval stage in 60 participants. More recent 41 trials are being conducted across 62 cities and 23 countries."

Answered by AI

How many people are allowed to enroll in this clinical trial?

"This particular trial is not taking any more participants at this time. The study was originally posted on 1/30/2014, with the latest update being 2/1/2022. There are currently 123 trials actively recruiting participants with thrombocytopenia and 9 studies for romiplostim actively looking for patients."

Answered by AI

In how many different research facilities is this trial being run today?

"There are presently 6 sites where this trial is taking place. They are based in New york, Harrison and Basking Ridge as well as other cities. Keep in mind that if you want to participate it might be best to select the clinic closest you, to minimize travel requirements."

Answered by AI

Is there a potential for serious harm to patients who take romiplostim?

"Romiplostim's safety is unproven but there is some data supporting its efficacy, so it received a score of 2."

Answered by AI
~5 spots leftby Mar 2025