Your session is about to expire
← Back to Search
Cedazuridine + Azacitidine for Leukemia
Study Summary
This trial is designed to test a new treatment for leukemia that is taken orally. The first phase will test different doses to find the best one. The second phase will compare the new treatment to the standard one given by injection. The third phase will test the best oral dose against the standard injection dose.
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.Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I haven't had chemotherapy in the last 4 weeks.I have had more than one cycle of specific chemotherapy treatments.I can swallow several pills within 10 minutes and fast for 4 hours.My liver function tests are within the required range.I have MDS/MPN and can feel swelling in my liver or spleen.I had a stem cell transplant without GVHD and haven't taken immunosuppressives for 2 weeks.I do not have any severe illnesses or conditions that could risk my safety in the study.I can carry out all my daily activities without help.I have MDS, CMML, MDS/MPN, or AML and am a candidate for azacitidine treatment.My condition is a specific type of blood disorder according to certain classifications.My organs are functioning well.I am not pregnant or breastfeeding and my pregnancy test was negative.I have not had any major surgery in the last 2 weeks.I have other serious health issues or infections that are not under control.I haven't taken any experimental drugs recently or have ongoing side effects from them.I have an active stomach or upper small intestine ulcer that's not under control.I've had cancer before, but it's either been treated successfully or I've been cancer-free for 2 years.You are allergic to cedazuridine or azacitidine, or any of the ingredients in these medications.My AML is untreated with 20-30% blasts in my bone marrow.My kidneys work well enough to clear waste from my blood.I have AML with over 30% blasts in my bone marrow and can't undergo stem cell transplant or intensive chemotherapy.
- Group 1: Phase 2, Sequence A
- Group 2: Phase 2, Sequence B
- Group 3: Phase 3, Sequence B
- Group 4: Phase 3, Sequence A
- Group 5: Phase 1, Stage A (Dose Escalation)
- Group 6: Phase 1, Stage B (Dose Expansion)
- 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
What are the main indications for ASTX030 (cedazuridine + azacitidine)?
"ASTX030, which is a combination of cedazuridine and azacitidine, can help patients with induction chemotherapy, ipss risk category intermediate-2, and refractory anemias."
How many people are the researchers investigating in this trial?
"In order for this study to be viable, 317 individuals that meet the pre-determined inclusion criteria must be recruited. The sponsor, Astex Pharmaceuticals, Inc., has set up this trial at multiple locations, such as MD Anderson Cancer Center in Houston, Texas and Roswell Park Comprehensive Cancer Center in Buffalo, New york."
Are new patients being sought for this research project?
"The clinical trial mentioned is still recruiting patients, with the original posting date being May 21st, 2020. The most recent edit was on October 4th, 2020."
Are there different sites within the city where this trial is being conducted?
"If you're considering enrolling in this trial, know that there are 7 sites currently recruiting patients.Patients are needed at locations including but not limited to Houston, Buffalo, and Nashville. To limit travel, it is best to select the location nearest to you."
Are there other examples of research using ASTX030 (cedazuridine + azacitidine)?
"ASTX030 (cedazuridine + azacitidine) is being trialed in 199 separate studies, 34 of which are in Phase 3. The large majority of these are taking place in Saint Louis, Missouri, though there are 5918 locations running these trials in total."
Share this study with friends
Copy Link
Messenger