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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be at least 21 or 28 days removed from the start of the chemotherapy cycle immediately prior to study day 1 if receiving a 21-day or 28-day cycle chemotherapy regimen, respectively.
Documented active stage I, II, III or IV locally advanced or metastatic of the following tumor types: NSCLC, breast cancer, or ovarian cancer (includes fallopian tube epithelial carcinomas and peritoneal epithelial carcinoma of unknown primary), or any stage recurrent disease. Patients with documented locally advanced (stage III) NSCLC should not be amenable to definitive treatment with chemoradiation and/or surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial looks at whether a drug called romiplostim can help cancer patients receiving chemotherapy to get their full dose on time.
Who is the study for?
Adults over 18 with advanced or recurrent NSCLC, breast, or ovarian cancer eligible for chemotherapy can join. They must have low platelet counts due to chemo and be able to undergo at least 3 more cycles. Exclusions include HIV, recent heart issues, other cancers within 5 years (with exceptions), active infections, certain blood disorders, and unwillingness to use contraception.Check my eligibility
What is being tested?
The trial is testing Romiplostim's effectiveness in treating low platelet counts caused by chemotherapy in patients with NSCLC, ovarian cancer, or breast cancer. The goal is to see if it helps them receive full-dose chemo on schedule without delays.See study design
What are the potential side effects?
Romiplostim may cause side effects like headache, dizziness, insomnia; muscle or joint pain; nausea or vomiting; fever; and an increased risk of blood clots. It might also lead to bone marrow changes resulting in abnormal blood cell levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I finished my last chemotherapy cycle at least 21 or 28 days ago, depending on the cycle length.
Select...
My cancer is advanced or has returned and includes lung, breast, or ovarian cancer.
Select...
I have at least 3 chemotherapy sessions left.
Select...
I can take care of myself and am up and about more than half of my waking hours.
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 either a chemotherapy dose delay or reduction
Secondary outcome measures
Depth of Platelet Count
Number of subjects who develop anti-TPO antibodies
Number of subjects who develop anti-romiplostim antibodies
+8 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
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
1,381 Previous Clinical Trials
1,379,500 Total Patients Enrolled
30 Trials studying Thrombocytopenia
4,197 Patients Enrolled for Thrombocytopenia
MDStudy DirectorAmgen
927 Previous Clinical Trials
926,544 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 undergoing a treatment plan that includes chemotherapy along with radiation therapy or surgery.Your platelet count must be less than or equal to 85,000 on the first day of the study.I have multiple myeloma.I have had a heart attack, mini-stroke, or stroke in the last 6 months.I finished my last chemotherapy cycle at least 21 or 28 days ago, depending on the cycle length.I agree to use contraception or abstain from sex during and for 7 months after treatment.I have not had an infection in the last 2 weeks.My low platelet count is not due to chemotherapy.I have acute lymphoblastic leukemia.I have acute myeloid leukemia.I haven't had any new or uncontrolled blood clots in the last 3 months.I have a type of blood cancer known as myeloid malignancy.I am 18 years or older.I have not had major surgery in the last 28 days or minor surgery in the last 3 days.You have HIV infection with detectable viral load.I haven't had another cancer besides the one I'm being treated for in the last 5 years.I agree not to donate sperm during and for 7 months after treatment.I have used certain medications or experimental treatments for platelet production.I am not pregnant, breastfeeding, nor planning to during and for 7 months after treatment.I have an active hepatitis B or C infection.I am on a 21- or 28-day cancer treatment cycle with specific drugs, or I am about to start one after a delay.My cancer is advanced or has returned and includes lung, breast, or ovarian cancer.You have low red or white blood cell counts, kidney problems, or liver problems based on recent lab tests.I have at least 3 chemotherapy sessions left.I haven't had serious heart issues or a heart attack in the last 4 months.I have been diagnosed with myelodysplastic syndrome.I am not willing to use effective birth control during and for 7 months after treatment.I can take care of myself and am up and about more than half of my waking hours.I have a disorder where my bone marrow makes too many blood cells.I am willing to use effective birth control during and 7 months after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Romiplostim
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current FDA stance on Romiplostim?
"Romiplostim has received a 3 for safety. This means that, while it is still in Phase 3 trials, there is already some data supporting both efficacy and multiple rounds of safe use."
Answered by AI
Are there other areas of research in which Romiplostim has been used?
"Romiplostim was first studied in 2014 at Memorial Sloan Kettering Bergen. Since then, there have been 18306 completed trials. Currently, 9 active trials are underway; many of these studies take place in Boston, Massachusetts."
Answered by AI
Who would the doctors consider for this clinical trial?
"This study intends to recruit 162 patients who have been diagnosed with ovarian cancer. All applicants must be aged 18 or 100 and meet the following additional criteria: Subjects must be receiving cancer treatment with 21- or 28-day cycles, using one of the following carboplatinum-based combination chemotherapy regimens: carboplatin/gemcitabine based, carboplatin/pemetrexed based, carboplatin/liposomal doxorubicin based or carboplatin/taxane based (which includes either paclitaxel, nab-paclitaxel, or docetaxel). Use of combination reg"
Answered by AI
How many test centers are conducting this experiment?
"Enrollment for this study is currently happening at 15 centres, which are situated in cities including Boston, Springfield and New Orleans. To make things more convenient for patients, it is best to choose a location that is close to them."
Answered by AI
Does this study have an upper age limit for participants?
"Eligibility requirements for this particular trial state that individuals must be aged between 18-100. In contrast, there are 84 other trials which exclusively involve patients under the age of eighteen and 2551 trials for people over the age of sixty-five."
Answered by AI
Are people currently allowed to sign up for this trial?
"That is correct, based on the information available from clinicaltrials.gov. The study in question was first posted on February 26th 2020 and has since enrolled 162 participants from 15 locations."
Answered by AI
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