NCT03303339

Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)

A Phase 1b/2 Study of PCM-075 (Onvansertib) in Combination With Either Low-Dose Cytarabine or Decitabine in Subjects With Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Cardiff Oncology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Onvansertib	Onvansertib orally
DRUG	Cytarabine	subcutaneously
DRUG	Decitabine	intravenously

Timeline

• Start date: 2017-11-17
• Primary completion: 2021-11-17
• Completion: 2021-11-17
• First posted: 2017-10-06
• Last updated: 2023-02-27
• Results posted: 2023-02-27

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study