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Thrombopoietin Receptor Agonist

Romiplostim for Low Platelet Count in Cancer (RECITE Trial)

Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Subjects must have at least 3 remaining planned cycles of chemotherapy at study enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights

RECITE Trial Summary

This trial is testing a drug to see if it can help people with cancer who have low blood platelet counts from their chemotherapy.

Who is the study for?
Adults over 18 with gastrointestinal, pancreatic, or colorectal cancer experiencing low platelet counts due to chemotherapy can join. They must be on certain chemo regimens and have at least 3 cycles left. Excluded are those with other blood disorders, recent major surgery or thrombosis, active infections including HIV and hepatitis B/C, pregnancy/breastfeeding women not using contraception, and anyone who's used similar drugs before.Check my eligibility
What is being tested?
The trial is testing Romiplostim against a placebo in patients with specific cancers who have developed thrombocytopenia from chemotherapy. The goal is to see if Romiplostim can increase their platelet counts and allow them to continue chemotherapy without delay.See study design
What are the potential side effects?
Romiplostim may cause side effects like headache, dizziness, insomnia, bone pain, muscle aches, joint pain; it might also increase the risk of blood clots. Since some people receive a placebo instead of the actual drug in this study design (randomly assigned), they would not experience these drug-related side effects.

RECITE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am able to care for myself and perform daily activities.
Select...
I have at least 3 chemotherapy sessions left.
Select...
I am on or starting a specific chemotherapy plan for my cancer.

RECITE Trial 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
Incidence of a Thrombocytopenia-induced chemotherapy dose modification during the second or third on study chemotherapy cycles.
Secondary outcome measures
AEs/SAEs overall safety of romiplostim
Bleeding Events
Depth of Platelet Count
+4 more

Side effects data

From 2010 Phase 3 trial • 313 Patients • NCT00116688
37%
Headache
34%
Nasopharyngitis
32%
Fatigue
30%
Contusion
26%
Upper respiratory tract infection
25%
Epistaxis
25%
Diarrhoea
24%
Nausea
24%
Arthralgia
24%
Cough
19%
Back pain
19%
Pain in extremity
18%
Petechiae
18%
Dizziness
17%
Oropharyngeal pain
16%
Vomiting
15%
Gingival bleeding
15%
Rash
14%
Oedema peripheral
14%
Insomnia
13%
Haematoma
13%
Sinusitis
12%
Pyrexia
12%
Urinary tract infection
12%
Myalgia
11%
Pain
11%
Abdominal pain
10%
Nasal congestion
10%
Paraesthesia
10%
Idiopathic thrombocytopenic purpura
10%
Muscle spasms
10%
Musculoskeletal pain
9%
Constipation
9%
Ecchymosis
9%
Rhinorrhoea
8%
Influenza
8%
Thrombocytopenia
8%
Bronchitis
8%
Pruritus
8%
Asthenia
8%
Dyspnoea
7%
Abdominal pain upper
7%
Dyspepsia
7%
Fall
7%
Anxiety
7%
Depression
7%
Oropharyngeal blistering
7%
Blood blister
7%
Mouth haemorrhage
6%
Procedural pain
6%
Skin lesion
6%
Hypertension
6%
Anaemia
6%
Abdominal discomfort
6%
Toothache
6%
Skin laceration
5%
Injection site haematoma
5%
Seasonal allergy
5%
Migraine
5%
Chest pain
5%
Joint swelling
5%
Dysuria
4%
Joint sprain
4%
Ear infection
4%
Gastroenteritis
4%
Chills
3%
Pneumonia
3%
Excoriation
2%
Myocardial infarction
2%
Cardiac failure congestive
2%
Viral infection
2%
Viral upper respiratory tract infection
2%
Arthropod bite
1%
Gastrointestinal haemorrhage
1%
Hip fracture
1%
Platelet count increased
1%
Urosepsis
1%
Syncope
1%
Dehydration
1%
Bone marrow disorder
1%
Osteoarthritis
1%
Respiratory failure
1%
Transient ischaemic attack
1%
Renal failure acute
1%
Vertigo
1%
Cholelithiasis
1%
Angina unstable
1%
Coronary artery disease
1%
Catheter related infection
1%
Mental status changes
1%
Renal failure
1%
Vaginal haemorrhage
1%
Cardiac failure
1%
Cholecystitis
1%
Hepatic neoplasm malignant
1%
Convulsion
1%
Acute myocardial infarction
1%
Atrial fibrillation
1%
Appendicitis
1%
Cellulitis
1%
Hernia obstructive
1%
Hepatic failure
1%
Colitis
1%
Rectal haemorrhage
1%
Platelet count decreased
1%
Hyperkalaemia
1%
Cerebrovascular accident
1%
Knee arthroplasty
1%
Deep vein thrombosis
1%
Mouth ulceration
1%
Animal bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Romiplostim in Adults
Romiplostim in Pediatric Population

RECITE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RomiplostimExperimental Treatment1 Intervention
The study in a 2:1 randomization ratio(108 subjects to romiplostim). Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
Group II: PlaceboPlacebo Group1 Intervention
The study in a 2:1 randomization ratio (54 subjects to placebo) Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
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?

AmgenLead Sponsor
1,355 Previous Clinical Trials
1,383,909 Total Patients Enrolled
30 Trials studying Thrombocytopenia
4,197 Patients Enrolled for Thrombocytopenia
MDStudy DirectorAmgen
899 Previous Clinical Trials
921,586 Total Patients Enrolled
22 Trials studying Thrombocytopenia
2,780 Patients Enrolled for Thrombocytopenia

Media Library

Romiplostim (Thrombopoietin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03362177 — Phase 3
Thrombocytopenia Research Study Groups: Romiplostim, Placebo
Thrombocytopenia Clinical Trial 2023: Romiplostim Highlights & Side Effects. Trial Name: NCT03362177 — Phase 3
Romiplostim (Thrombopoietin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03362177 — Phase 3

Frequently Asked Questions

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

Does this research project require all participants to be under the age of 50?

"Eligibility for this research study requires that patients are aged 18 to 100. Out of the 1,046 total clinical trials taking place, 56 are geared towards those under 18 and 990 are for seniors."

Answered by AI

Are there any vacancies in this clinical trial for new patients?

"According to the latest update on clinicaltrials.gov, this trial is still recruiting patients. The post was made on September 30th, 2019 and updated October 26th, 2022."

Answered by AI

What is the regulatory status of Romiplostim in the United States?

"Romiplostim has received a score of 3 for safety. This is because it is in Phase 3 trials, which suggests that not only is there some evidence of efficacy, but also multiple rounds of data affirming its safety."

Answered by AI

Are there any other notable experiments that have been conducted with Romiplostim?

"Bergen's Memorial Sloan Kettering was the first to study romiplostim in 2014. So far, there have been 18317 completed trials and 9 more are presently recruiting patients. A large portion of these studies take place in Shreveport, Louisiana."

Answered by AI

Where are the facilities that are participating in this research project located?

"There are 15 sites participating in this study, including CHRISTUS Highland Cancer Treatment Center in Shreveport, American Oncology Partners of Maryland, PA in Bethesda, Pacific Cancer Medical Center Inc in Anaheim, and other locations."

Answered by AI

How can I sign up for the clinical trial?

"This clinical trial is looking for 162 patients with colorectal cancer who are between 18 and 100 years old. Applicants must meet the following criteria: They must have given informed consent prior to any study-specific activities or procedures, or their legally acceptable representative has done so in cases where the applicant cannot do so themselves due to a condition that, in the opinion of the investigator, may compromise their ability to give informed consent. Additionally, they must be male or female, and greater than or equal to 18 years of age at signing of the informed consent. Furthermore, they must have a histologically or cytologically confirmed diagnosis of"

Answered by AI

Has this research been done before?

"Clinical research surrounding Romiplostim dates back to 2014. After the first successful trial involving 60 patients, Amgen sponsored a Phase 2 drug approval in 2014. Presently, 9 active studies are conducted in 62 cities and 23 countries."

Answered by AI

How many individuals are being research subjects in this trial?

"That is correct, the information available on clinicaltrials.gov verifies that this study is still looking for patients to enroll. The trial was first posted on September 30th, 2019 and has since been updated October 26th, 2020. In total, they are looking for 162 individuals across 15 sites."

Answered by AI
~30 spots leftby Mar 2025