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Study Summary
This trial will test if a medication can safely help thrombocytopenia patients finish their temozolomide cancer treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 3 trial • 49 Patients • NCT01438840Trial Design
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Who is running the clinical trial?
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- I cannot take medicine by mouth.I haven't taken vitamin K antagonists in the last 7 days.I have a genetic condition that increases my risk of blood clots.I do not have any health conditions that would make it unsafe for me to participate in the study.I had a solid tumor and was treated with chemotherapy, with or without radiation, in the last 5 years.I have had radiation therapy to my pelvic area before.I have had a blood clot in the last 6 months.I am not pregnant or breastfeeding.I have had severe low platelet counts twice, 24 hours apart, during my cancer treatment.I haven't had any serious bleeding episodes in the last week.I have a history of blood cancer.I received a platelet transfusion within the last 3 days.I have a long-term bleeding or platelet disorder not caused by temozolomide.I have undergone more than two chemotherapy treatments.I can continue taking temozolomide at the standard dose and schedule.I have not been in a drug or device trial within the last 30 days, but observational studies are okay.I am 18 years old or older.I have had serious heart issues or procedures in the last 6 months.I am expected to live more than 12 weeks and can receive at least 2 more TMZ treatments.My brain tumor is confirmed to be grade 2, 3, or 4.I have been treated with drugs like eltrombopag or romiplostim for low platelet counts caused by temozolomide.I am currently undergoing radiation therapy and temozolomide treatment, with plans for 6-12 cycles of temozolomide.I have not taken drugs like rifampin or fluconazole in the last week.I can take care of myself and am up and about more than half of my waking hours.I agree to use effective birth control during and for 28 days after the study.
- Group 1: Experimental: Avatrombopag
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many participants have enrolled in this trial thus far?
"Affirmative. According to clinicaltrials.gov, this research study is still recruiting participants since its launch on May 6th 2022 and last amendment on June 9th 2022. The investigation requires 24 patients from a single location for participation."
Is this an innovative medical experiment?
"At the moment, there are 11 active clinical trials for Avatrombopag in 78 urban centres across 11 nations. The initial research into this drug was undertaken by Dova Pharmaceuticals and contained 122 participants; it concluded its Phase 3 approval stage in 2018. Subsequently, 19 more studies have been conducted since then."
Are more participants still being sought for this research endeavor?
"Yes, clinicaltrials.gov confirms that this trial is actively seeking participants. It was first made available on May 6th 2022 and the details were last updated just a few days ago on June 9th 2022. A total of 24 volunteers are needed from 1 site."
Could you outline previous investigations related to Avatrombopag?
"Presently, there are 11 clinical trials that involve Avatrombopag. Of those investigations, 3 have reached the third phase of research. Most studies occur in Paris Cedex 19, Ile De France; yet many other sites across the world (216) are conducting their own experiments on this pharmaceutical product."
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