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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year
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 moreSide effects data
From 2010 Phase 3 trial • 313 Patients • NCT0011668850%
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%
Haematoma
5%
Migraine
5%
Anaemia
5%
Muscle spasms
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
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
1,383 Previous Clinical Trials
1,379,759 Total Patients Enrolled
30 Trials studying Thrombocytopenia
4,197 Patients Enrolled for Thrombocytopenia
MDStudy DirectorAmgen
929 Previous Clinical Trials
926,806 Total Patients Enrolled
22 Trials studying Thrombocytopenia
2,780 Patients Enrolled for Thrombocytopenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to care for myself and perform daily activities.I have acute lymphoblastic leukemia.I finished my last chemotherapy cycle at least 14 or 21 days ago, depending on the type.I have at least 3 chemotherapy sessions left.I have been diagnosed with multiple myeloma.I am on or starting a specific chemotherapy plan for my cancer.I have a type of blood cancer affecting my bone marrow.I have not had an infection in the last 2 weeks.My kidney function is low, with a creatinine clearance rate of at least 30 mL/min.I haven't had serious heart issues like heart failure or a heart attack in the last 4 months.I have not had major surgery in the last 28 days or minor surgery in the last 3 days.I am not pregnant or breastfeeding and do not plan to during or for 6 months after treatment.I agree to use contraception during and 6 months after treatment.I agree to use contraception or practice abstinence during and for 6 months after my treatment.My cancer is in the esophagus, stomach, pancreas, colon, or rectum.I have been diagnosed with HIV.My white blood cell count is low, but I can receive treatment to increase it.I have used medications to increase my platelet count before.I have anemia with hemoglobin levels below 8 g/dL.I agree not to donate sperm during and for 6 months after treatment.I have myelodysplastic syndrome but haven't necessarily had a bone marrow biopsy.I have had a stable blood clot and been on blood thinners for at least 14 days.My liver tests are much higher than normal.I am 18 years or older and have signed the informed consent.I have an active hepatitis B or C infection.I haven't had cancer, except for specific types treated over 5 years ago.I am not willing to use effective birth control during and 6 months after treatment.I have had a stroke or mini-stroke in the last 6 months.I have a disorder that affects my blood cells.I have acute myeloid leukemia.
Research Study Groups:
This trial has the following groups:- Group 1: Romiplostim
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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