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NCT01303796 · ClinicalTrials.gov registry record · Phase 3
A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase 3 study, sponsored by Cyclacel Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 482
- Enrollment target
NCT01303796 is a Phase 3 study that has completed, run by Cyclacel Pharmaceuticals. The registered enrollment target is 482 participants.
The verdict
NCT01303796, a Phase 3 study, has completed, sponsored by Cyclacel Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 482 participants
- Enrollment target
Study Summary
This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.
Interventions
- DRUG Decitabine
- DRUG Sapacitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 482 participants |
| Start Date | 2011-10-01 |
| Est. Completion | 2017-07-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01303796
The ClinicalTrials.gov registry entry for NCT01303796 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 482 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cyclacel Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Decitabine is the first listed.
NCT01303796 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01303796 about?
NCT01303796 is a clinical study titled "A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia". This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard ...
What is the current status of trial NCT01303796?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 482 participants. The study started on 2011-10-01. Estimated completion is 2017-07-31.
What interventions are being tested in trial NCT01303796?
The interventions under investigation include: Decitabine (DRUG), Sapacitabine (DRUG).
Who is sponsoring clinical trial NCT01303796?
This trial is sponsored by Cyclacel Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
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