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NCT03303339 · ClinicalTrials.gov registry record · Phase 1
Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by Cardiff Oncology.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT03303339 is a Phase 1 study that has completed, run by Cardiff Oncology. The registered enrollment target is 72 participants.
The verdict
NCT03303339, a Phase 1 study, has completed, sponsored by Cardiff Oncology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
The purpose of the phase 1b/2 study is to determine whether Onvansertib given orally daily for 5 consecutive days every 28 days is safe and tolerable in adult patients who have relapsed/refractory Acute Myeloid Leukemia (AML), or are ineligible for intensive induction therapy, and to determine the maximum tolerated dose and recommended phase 2 dose of Onvansertib in combination with decitabine or Onvansertib in combination with low-dose cytarabine. In the phase 2 portion of the study, Onvansertib in combination with decitabine will be studied to provide further data on the safety profile of the combination and to preliminarily assess the activity of the chosen combination in patients with untreated AML who are not candidates for aggressive induction therapy, or who have received one prior treatment for their AML.
Interventions
- DRUG Decitabine
- DRUG Cytarabine
- DRUG Onvansertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2017-11-17 |
| Est. Completion | 2021-11-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03303339
The ClinicalTrials.gov registry entry for NCT03303339 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cardiff Oncology, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Decitabine is the first listed.
NCT03303339 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03303339 about?
NCT03303339 is a clinical study titled "Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)". The purpose of the phase 1b/2 study is to determine whether Onvansertib given orally daily for 5 consecutive days every 28 days is safe and tolerable in adult patients who have relapsed/refractory Acute Myeloid Leukemia (AML), or are ineligible for intensive induction therapy, and to determine the m...
What is the current status of trial NCT03303339?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2017-11-17. Estimated completion is 2021-11-17.
What interventions are being tested in trial NCT03303339?
The interventions under investigation include: Decitabine (DRUG), Cytarabine (DRUG), Onvansertib (DRUG).
Who is sponsoring clinical trial NCT03303339?
This trial is sponsored by Cardiff Oncology, which has 6 total clinical trials registered on ClinicalTrials.gov.
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