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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.
Must not have
Acute lymphoblastic leukemia.
Multiple myeloma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year
Awards & highlights
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have acute lymphoblastic leukemia.
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I have been diagnosed with multiple myeloma.
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I have a type of blood cancer affecting my bone marrow.
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My kidney function is low, with a creatinine clearance rate of at least 30 mL/min.
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I haven't had serious heart issues like heart failure or a heart attack in the last 4 months.
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I have not had major surgery in the last 28 days or minor surgery in the last 3 days.
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I have used medications to increase my platelet count before.
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I have anemia with hemoglobin levels below 8 g/dL.
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I agree not to donate sperm during and for 6 months after treatment.
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My liver tests are much higher than normal.
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I have an active hepatitis B or C infection.
Select...
My white blood cell count is low, but I can receive treatment to increase it.
Select...
I have a disorder that affects my blood cells.
Select...
I have acute myeloid leukemia.

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~2240

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,433 Previous Clinical Trials
1,394,999 Total Patients Enrolled
MDStudy DirectorAmgen
971 Previous Clinical Trials
939,171 Total Patients Enrolled

Media Library

Romiplostim (Thrombopoietin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03362177 — Phase 3
Low Platelet Count Research Study Groups: Romiplostim, Placebo
Low Platelet Count 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
~27 spots leftby Nov 2025
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