Study for Participants Continuing ASTX727 Treatment from Previous Clinical Trials
Sponsor: Taiho Oncology, Inc.
ClinicalTrials ID:NCT04093570
This study is for participants who were benefiting from ASTX727 treatment in previous clinical trials and wish to continue receiving the medication. It aims to provide long-term safety information for those who have been part of earlier studies involving ASTX727.
Patient Parameters
| Parameter | Options |
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Program Overview
This study allows participants who were part of previous clinical trials with ASTX727 to continue their treatment. The goal is to gather long-term safety data for ASTX727, a medication used in treating certain blood disorders and cancers. Participants will continue to receive the same dose and schedule of ASTX727 as in their previous study, with adjustments made by the study doctor if necessary.
Description
Participants in this study will visit the clinic on the first day of each 28-day cycle to receive ASTX727 tablets for the first five days of the cycle. They will continue with the same dose and schedule they had in their previous study. The study doctor may adjust the treatment schedule if needed.
For those who were part of the Food Effect Substudy, the study looked at how food affects the absorption of ASTX727. Participants received the medication with different types of meals and in a fasted state. This substudy has now been completed, but participants can continue with ASTX727 treatment if the study doctor agrees.
The study includes a screening period, a treatment period, and a follow-up period if participants stop the ASTX727 treatment.
Eligibility Criteria
Inclusion Criteria
- Previously participated in a clinical trial with ASTX727 and were still receiving the treatment when the study ended.
- Benefiting from ASTX727 treatment according to the study doctor.
- Able to understand and follow study procedures and aware of the risks involved.
- Provide informed consent before starting the study.
- Women of childbearing potential must not be pregnant or breastfeeding, must have a negative pregnancy test, and agree to use effective birth control during the study and for six months after. Men must also agree to use effective birth control during the study and for three months after.
For the Food Effect Substudy:
- Diagnosed with specific blood disorders or cancers, such as myelodysplastic syndromes or acute myeloid leukemia, and not suitable for intensive chemotherapy.
- ECOG performance status of 0 to 2, indicating good overall health.
- Adequate liver and kidney function based on specific blood tests.
Exclusion Criteria
- Any condition or organ dysfunction that may make continuing ASTX727 treatment unsafe, according to the study doctor.
For the Food Effect Substudy:
- Allergies to ASTX727 or its ingredients.
- Poor health due to other uncontrolled diseases or infections.
- Serious medical conditions that could affect the study's safety or results.
- Previous stomach surgery that affects digestion.
- Currently needing chemotherapy for another cancer, except for stable breast or prostate cancer on hormone therapy.
- Known HIV or hepatitis B or C infection.
- Active stomach or duodenal ulcers.
- Acute promyelocytic leukemia.
- Previous chemotherapy for AML, except for hydroxyurea.
- Recent treatment with another investigational drug or ongoing side effects from such treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Compassionate Care Research Group | 92708 | Fountain Valley | California |
| Boca Raton Clinical Research | 33322 | Plantation | Florida |
| The University of Chicago Medical Center | 60637 | Chicago | Illinois |
| The Sidney Kimmel Comprehensive Cancer Center at John Hopkins | 21231 | Baltimore | Maryland |
| Cancer and Hematology Centers for Western Michigan | 49503 | Grand Rapids | Michigan |
| Mayo - Rochester | 55905 | Rochester | Minnesota |
| Hackensack Medical Center - 06 FE Study | 07601 | Hackensack | New Jersey |
| Hackensack Medical Center | 07601 | Hackensack | New Jersey |
| Rosewell Park Cancer Institute | 14263 | Buffalo | New York |
| Roswell Park Cancer Institute - 06 FE Study | 14263 | Buffalo | New York |
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