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Romiplostim for Solid Tumors

Phase 2
Waitlist Available
Led By MIchael Ortiz, 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 younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study Summary

This trial will test whether a drug can help prevent chemotherapy-induced low platelet counts, reduce transfusions, and prevent treatment delays.

Eligible Conditions
  • Solid Tumors
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total Number of Platelet Transfusions During the Studied Portions of the EFT or D9803 Cycles

Side effects data

From 2010 Phase 3 trial • 313 Patients • NCT00116688
50%
Upper respiratory tract infection
45%
Cough
45%
Headache
45%
Pyrexia
45%
Petechiae
40%
Contusion
35%
Fatigue
35%
Vomiting
30%
Oropharyngeal pain
30%
Nasal congestion
25%
Gingival bleeding
25%
Epistaxis
25%
Rhinorrhoea
25%
Rash
25%
Nasopharyngitis
25%
Arthralgia
20%
Abdominal pain upper
20%
Pain
20%
Mouth haemorrhage
20%
Nausea
15%
Abdominal pain
15%
Excoriation
15%
Myalgia
15%
Viral upper respiratory tract infection
10%
Ear infection
10%
Chills
10%
Idiopathic thrombocytopenic purpura
10%
Pain in extremity
10%
Dyspnoea
10%
Diarrhoea
10%
Joint sprain
10%
Gastroenteritis
10%
Scab
10%
Dizziness
10%
Mouth ulceration
10%
Viral infection
10%
Animal bite
10%
Arthropod bite
10%
Procedural pain
5%
Constipation
5%
Migraine
5%
Anaemia
5%
Muscle spasms
5%
Haematoma
5%
Musculoskeletal pain
5%
Abdominal discomfort
5%
Pharyngitis streptococcal
5%
Seasonal allergy
5%
Influenza
5%
Bronchitis
5%
Ecchymosis
5%
Skin lesion
5%
Toothache
5%
Chest pain
5%
Sinusitis
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Romiplostim in Pediatric Population
Romiplostim in Adults

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pediatric ParticipantsExperimental Treatment1 Intervention
Male and female patients aged 1-21 years with a primary solid tumor undergoing treatment with the pre-defined chemotherapy regimens of EFT, MAP or D9803.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Romiplostim
2015
Completed Phase 3
~2290

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,853 Total Patients Enrolled
MIchael Ortiz, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Michael Ortiz, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
86 Total Patients Enrolled

Frequently Asked Questions

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

To whom is this trial available?

"The requirements to participate in this clinical trial are having cancer and being between 1 year old up to 21 years old. There is space for 2 patients."

Answered by AI

Is this clinical trial accessible in many locations around the United States?

"There are 7 clinical trial sites available, 3 of which are Memorial Sloan Kettering locations in Montvale (Limited Protocol Activities), Basking Ridge (Limited Protocol Activities), and Harrison (Limited Protocol Activitites). 4 other centres are also participating."

Answered by AI

Are there precedent studies for this type of medical research?

"Romiplostim, a medication used to treat certain blood disorders, is the focus of 9 current clinical trials. These studies are being conducted in 23 different countries and across 62 cities. The first Romiplostim trial was completed in 2014 by Amgen. This Phase 2 study had 60 participants. 41 additional trials have been run since then."

Answered by AI

Can new patients still join the trial?

"Unfortunately, this particular clinical trial is no longer looking for patients. The study began on December 10th 2020 but was last updated on October 21st 2022. However, there are other active trials you may be eligible for; 2683 cancer trials and 9 Romiplostim studies are currently admitting patients."

Answered by AI

Are there any long-term effects of Romiplostim that patients should be aware of?

"Romiplostim's safety is estimated to be a 2 because, while there are Phase 2 trials underway testing its efficacy, right now there is only data supporting its safety."

Answered by AI

Is this trial open to patients who are below the age of 25 years old?

"For this particular trial, participants must fall in the age range of 1 year to 21 years old. There are a total of 338 clinical trials for patients under 18 and 2485 for those over 65."

Answered by AI

How many individuals are receiving care through this program?

"The most recent update on this particular trial was from 10/21/2022, which means the study is no longer actively recruiting. However, there are 2683 other trials currently looking for cancer patients and 9 trials that involve Romiplostim still enrolling individuals."

Answered by AI

Are there similar treatments to Romiplostim that have been trialed before?

"Romiplostim was first studied in 2014 at Memorial Sloan Kettering Bergen. As of now, there have been 41 completed clinical trials with 9 active studies. Currently, a majority of the active romiplostim clinical trials are taking place in Montvale, New york."

Answered by AI
~0 spots leftby Apr 2025