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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: Completed Phase 1 study, sponsored by Cardiff Oncology.
NCT03303339 is a Phase 1 study that has completed, run by Cardiff Oncology. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Dose-limiting toxicities were defined as events related to onvansertib that were considered an adverse reaction or suspected adverse reaction during the first cycle of therapy and that fulfilled one of the following: Hematologic (persistent pancytopenia resistant to current standards of care that continues for ≥42 days and is not related to leukemic infiltration or another cause unrelated to study therapy) or Non-Hematologic (any Grade 3 abnormalities that persist \>7 days without decreasing in
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 |
What the finished NCT03303339 record still lists
NCT03303339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 3 interventions - of which Decitabine is the first listed.
NCT03303339 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03303339's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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