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Thrombopoietin Receptor Agonist
Avatrombopag for Thrombocytopenia in Gastrointestinal Cancer (ACT-GI Trial)
Phase 2
Recruiting
Led By Gerald A Soff, MD
Research Sponsored by Hanny Al-Samkari, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, days 8 +/-1 and 15 +/-1
Summary
This trial will compare how well these drugs work to treat CIT in patients with GI malignancies receiving chemotherapy.
Who is the study for?
This trial is for adults with gastrointestinal cancers who are undergoing chemotherapy and have a low platelet count, known as Chemotherapy-Induced Thrombocytopenia (CIT). They must not have certain blood disorders or be planning to receive other investigational drugs. Participants should not be pregnant, breastfeeding, or have had recent bleeding events.
What is being tested?
The study compares Avatrombopag, a drug that stimulates platelet production, against a placebo in patients with CIT from GI cancer treatments. The goal is to see if Avatrombopag can better manage low platelet counts during chemotherapy cycles.
What are the potential side effects?
Potential side effects of Avatrombopag may include headache, fatigue, bruising or bleeding more easily than normal. As it affects blood clotting processes, there could also be risks of developing blood clots.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, days 8 +/-1 and 15 +/-1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, days 8 +/-1 and 15 +/-1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Response Rate
Response Rate of CIT Treatment in Avatrombopag
Response Rate of CIT Treatment in Placebo Group
Secondary study objectives
Proportion of Platelet Count Recovery in Avatrombopag Group
Proportion of Platelet Count Recovery in Placebo Group
Rate of Clinically Relevant Bleeding Events in Avatrombopag Group
+7 moreSide effects data
From 2014 Phase 3 trial • 49 Patients • NCT0143884038%
Headache
31%
Contusion
19%
Upper respiratory tract infection
13%
Gingival bleeding
13%
Arthralgia
13%
Fatigue
13%
Epistaxis
13%
Petechiae
9%
Nasopharyngitis
9%
Insomnia
9%
Mouth Haemorrhage
9%
Nausea
9%
Back pain
6%
Anaemia
6%
Influenza
6%
Thrombocytopenia
6%
Vomiting
6%
Blood gastrin increased
6%
Cough
6%
Hypertension
3%
Dyspepsia
3%
Cerebrovascular accident
3%
Mouth haemorrhage
3%
Food poisoning
3%
Polyserositis
3%
Uterine haemorrhage
3%
Urinary tract infection
3%
Platelet count decreased
3%
Deep vein thrombosis
3%
Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avatrombopag (Core Study)
Avatrombopag (Extension Phase)
Placebo (Core Study)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group A - AvatromopagExperimental Treatment1 Intervention
30 participants will be randomized into a 1:1 fashion and will be stratified based on the number of cytotoxic agents in the patient's chemotherapy regimen. Participants will complete study procedures as outlined:
Lead-In Period (Day 1 - 15)
* Pre-determined dose of Avatrombopag 1x daily.
* Participants failing to achieve a platelet count ≥100,000/µL within 2 weeks will be considered a treatment failure (and will proceed to the end-of-study visit).
On-Cycle Period (Day 15 - up to Week 6)
• Pre-determined dose of Avatrombopag 1x daily.
Follow-up Period
* End of Treatment on-site visit.
* Follow-up visit 30-42 days after End of Treatment visit.
Group II: Group B - Matching PlaceboActive Control1 Intervention
30 participants will be randomized into a 1:1 fashion and will be stratified based on the number of cytotoxic agents in the patient's chemotherapy regimen. Participants will complete study procedures as outlined:
Lead-In Period (Day 1 - 15)
* Pre-determined dose of matching placebo 1x daily.
* Participants failing to achieve a platelet count ≥100,000/µL within 2 weeks will be considered a treatment failure (and will proceed to the end-of-study visit).
On-Cycle Period (Day 15 - up to Week 6)
• Pre-determined dose of matching placebo 1x daily.
Follow-up Period
* End of Treatment on-site visit.
* Follow-up visit 30-42 days after End of Treatment visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avatrombopag
2016
Completed Phase 3
~490
Find a Location
Who is running the clinical trial?
Hanny Al-Samkari, MDLead Sponsor
1 Previous Clinical Trials
33 Total Patients Enrolled
Swedish Orphan BiovitrumIndustry Sponsor
99 Previous Clinical Trials
13,008 Total Patients Enrolled
Gerald A Soff, MDPrincipal InvestigatorUniversity of Miami Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had blood cancer in the past.I can care for myself and doctors expect me to live more than 12 weeks.I received a platelet transfusion within the last 3 days.I am 18 years old or older.I haven't had chemotherapy in the last 14 days, with certain exceptions.I have low platelet counts due to chemotherapy for over a month.I plan to keep my current chemotherapy dose and schedule for at least one more cycle, if my blood platelet count is okay.I have received radiation treatment to my pelvis area of more than 20 Gy.I have had a significant blood clot or artery blockage event.My cancer has spread to my bones or bone marrow.I do not have any unmanaged ongoing illnesses.I have not had significant bleeding in the week before giving my consent.I cannot take medicine by mouth.I have a long-term platelet disorder or low platelet count not caused by CIT.I have taken a medication for platelet increase within the last 14 days.My organs and bone marrow are functioning well.I am currently receiving chemotherapy for a stomach or intestine cancer.I am willing and able to follow the study's requirements.I am on a chemotherapy schedule that repeats every 2, 3, or 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Group A - Avatromopag
- Group 2: Group B - Matching Placebo
Awards:
This trial has 0 awards, including: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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