NCT03303339 is a Phase 1, PHASE2 clinical trial of Onvansertib in Acute Myeloid Leukemia, sponsored by Cardiff Oncology.

Who is sponsoring NCT03303339?

NCT03303339 is sponsored by Cardiff Oncology.

What drugs are being tested in NCT03303339?

Interventions in NCT03303339: Onvansertib, Cytarabine, Decitabine.

What condition does NCT03303339 study?

NCT03303339 studies Acute Myeloid Leukemia.

Is NCT03303339 still recruiting?

NCT03303339 is currently completed. Last updated 27 February 2023.

Are results published for NCT03303339?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-02-27 · How we verify

NCT03303339

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1, PHASE2 Results posted Last updated 27 February 2023

What this trial tests

Phase 1, PHASE2 trial testing Onvansertib in Acute Myeloid Leukemia in 72 participants. Completed in 17 November 2021.

Timeline

17 November 2017

Primary endpoint
17 November 2021

17 November 2021

Quick facts

Lead sponsor	Cardiff Oncology
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	17 November 2017
Primary completion	17 November 2021
Estimated completion	17 November 2021
Sites	9 locations across United States

Drugs / interventions tested

Onvansertib (onvansertib) — full drug profile →
Cytarabine — full drug profile →
Decitabine (decitabine) — full drug profile →

Conditions studied

Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →

Sponsor

Cardiff Oncology — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Experienced Dose Limiting Toxicities (DLT) Primary · Up to Day 28 of Cycle 1

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 severity despite standards of care, are clinically significant, or that are Grade 4 and symptomatic)

Group	Value	95% CI
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine	0
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine	0
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine	0
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine	0
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine	0
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine	0
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine	0
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine	0
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine	0
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine	0
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine	2

Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status Primary · Baseline and end of study (approximately up to up to 27 months)

ECOG performance status was determined using 6-point scale from 0-5, with 0 meaning a participant was fully active/able to carry on all pre-disease activities without restriction and 5 meaning the participant was deceased.

Group	Value	95% CI
Phase 1b: Onvansertib + Low-dose Cytarabine	11
Phase 1b: Onvansertib + Decitabine	14
Phase 2: Onvansertib + Decitabine	22

Phase 2: Number of Participants Who Achieved a Complete Response (CR) Primary · Up to 27 months

Complete Response also includes Complete Response with Incomplete Blood Count Recovery (CRi). Complete response is defined by the following criteria: Morphologic leukemia-free state plus: * Subject is independent of transfusions * Absolute neutrophil count of \>1000/mm3 * Platelets of ≥100,000/mm3 Complete response with incomplete blood count recovery meets all criteria for CR except for either neutropenia (ANC \<1000/mm3) or thrombocytopenia (\<100,000/mm3) but must include transfusion independence.

Group	Value	95% CI
Phase 2: Onvansertib + Decitabine	3

Number of Participants With Adverse Events (AEs) Primary · Baseline up to 30 days after last dose of study drug (up to 27 months)

Any clinically significant change in electrocardiogram (ECG), physical examination findings, body weight, vital signs, and laboratory parameters were recorded as Adverse Events.

Any Adverse Events

Group	Value	95% CI
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine	3
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine	3
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine	3
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine	3
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine	5
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine	4
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine	3
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine	3
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine	4
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine	3
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine	6
Phase 2: Onvansertib 60 mg/m^2 + Decitabine	32

Any Serious Adverse Events

Group	Value	95% CI
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine	2
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine	3
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine	1
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine	2
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine	3
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine	2
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine	3
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine	3
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine	4
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine	2
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine	5
Phase 2: Onvansertib 60 mg/m^2 + Decitabine	27

Any Treatment-Related Serious Adverse Events

Group	Value	95% CI
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine	0
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine	1
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine	0
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine	1
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine	0
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine	0
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine	0
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine	1
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine	0
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine	1
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine	3
Phase 2: Onvansertib 60 mg/m^2 + Decitabine	5

Phase 2: Number of Participants Who Achieved a Morphologic Leukemia-free (MLF) State Secondary · Up to 27 months

Defined as bone marrow (BM) \<5% blasts in an aspirate with spicules and no blasts with Auer rods or persistence of extramedullary disease.

Group	Value	95% CI
Phase 2: Onvansertib + Decitabine	1

Phase 2: Number of Participants With Partial Response (PR) Secondary · Up to 27 months

PR criteria includes all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate and a normalization of blood counts.

Group	Value	95% CI
Phase 2: Onvansertib + Decitabine	0

Phase 2: Duration of Response (DOR) Secondary · Up to 27 months

Duration of Response (DOR) is the time (in months) from the first response of CR, CRi or PR until recurrence of or progression of disease (or death). MLF State is also included as a response when calculating DOR. Responding subjects without death or progression will be censored at the date of their last evaluable disease assessment.

Group	Value	95% CI
Phase 2: Onvansertib + Decitabine	5.2	0.0 – 9.1

Phase 2: Event-free Survival (EFS) Secondary · 12 Months

EFS is defined as the time from enrollment until disease progression or death from any cause and reported as the proportion of participants event free at 12 months.

Group	Value	95% CI
Phase 2: Onvansertib + Decitabine	0.1	0.0 – 0.2

Phase 2: Overall Survival (OS) Secondary · 12 Months

OS is defined as the time from enrollment until death from any cause and reported as the proportion of participants alive at 12 months.

Group	Value	95% CI
Phase 2: Onvansertib + Decitabine	0.2	0.1 – 0.4

Pharmacokinetic Parameter: Maximum Observed Plasma Concentration (Cmax) for Onvansertib Secondary · Cycle 1: Days 1 and 5

Cycle 1 Day 1

Group	Value	95% CI
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine	92.57	± 5.66
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine	69.56	± 28.73
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine	251.16	± 85.37
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine	256.11	± 24.96
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine	626.18	± 61.37
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine	80.15	± 21.33
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine	129.18	± 93.78
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine	309.86	± 72.47
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine	410.42	± 26.38
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine	724.76	± 57.33
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine	737.21	± 43.06
Phase 2: Onvansertib 60 mg/m^2 + Decitabine	515.63	± 43.47

Cycle 1 Day 5

Group	Value	95% CI
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine	139.22	± 55.12
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine	103.27	± 43.01
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine	298.63	± 66.58
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine	339.52	± 31.25
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine	857.29	± 38.54
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine	146.10	± 56.75
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine	197.67	± 85.14
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine	398.38	± 32.95
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine	496.24	± 52.72
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine	955.59	± 54.78
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine	1137.16	± 61.56
Phase 2: Onvansertib 60 mg/m^2 + Decitabine	861.86	± 46.68

Pharmacokinetic Parameter: Time to Reach the Maximum Observed Plasma Concentration (Tmax) for Onvansertib Secondary · Cycle 1: Days 1 and 5

Cycle 1 Day 1

Group	Value	95% CI
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine	1.961	± 81.664
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine	2.548	± 96.282
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine	2.301	± 84.217
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine	1.384	± 103.829
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine	2.071	± 39.570
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine	3.102	± 31.792
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine	2.365	± 78.396
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine	1.288	± 41.249
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine	1.373	± 49.676
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine	2.893	± 135.893
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine	2.435	± 53.682
Phase 2: Onvansertib 60 mg/m^2 + Decitabine	2.725	± 69.661

Cycle 1 Day 5

Group	Value	95% CI
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine	1.844	± 62.646
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine	2.892	± 37.244
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine	2.267	± 82.486
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine	1.474	± 67.999
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine	2.148	± 55.159
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine	2.438	± 24.524
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine	1.583	± 96.305
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine	3.145	± 33.877
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine	3.161	± 41.350
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine	3.161	± 41.350
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine	3.189	± 29.775
Phase 2: Onvansertib 60 mg/m^2 + Decitabine	2.665	± 51.333

Pharmacokinetic Parameter: Area Under the Curve Over the First 24 Hours AUC(0-24) for Onvansertib Secondary · Cycle 1: Days 1 and 5

Cycle 1 Day 1

Group	Value	95% CI
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine	1197.93	± 23.42
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine	772.68	± 26.21
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine	2534.22	± 31.05
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine	2761.11	± 36.97
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine	5386.69	± 59.16
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine	1099.43	± 29.81
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine	2789.81	± 25.30
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine	3257.57	± 53.53
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine	4084.18	± 27.94
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine	9599.19	± 25.01
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine	9087.77	± 57.43
Phase 2: Onvansertib 60 mg/m^2 + Decitabine	6280.28	± 46.85

Cycle 1 Day 5

Group	Value	95% CI
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine	1868.69	± 70.99
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine	3626.44	± 5.33
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine	5343.01	± 2.11
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine	7415.04	± 64.35
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine	19470.17	± 17.10
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine	1868.69	± 70.99
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine	3626.44	± 5.33
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine	5343.01	± 2.11
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine	7415.04	± 64.35
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine	19470.17	± 17.10
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine	12981.17	± 56.18
Phase 2: Onvansertib 60 mg/m^2 + Decitabine	11767.29	± 39.78

Adverse events — posted to ClinicalTrials.gov

Time frame: 27 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine

Serious: 2/3 (67%)

Deaths: 2/3

Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine

Serious: 3/3 (100%)

Deaths: 2/3

Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine

Serious: 1/3 (33%)

Deaths: 2/3

Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine

Serious: 2/3 (67%)

Deaths: 1/3

Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine

Serious: 3/5 (60%)

Deaths: 4/5

Phase 1b: Onvansertib 12 mg/m^2 + Decitabine

Serious: 2/4 (50%)

Deaths: 2/4

Phase 1b: Onvansertib 18 mg/m^2 + Decitabine

Serious: 3/3 (100%)

Deaths: 2/3

Phase 1b: Onvansertib 27 mg/m^2 + Decitabine

Serious: 3/3 (100%)

Deaths: 2/3

Phase 1b: Onvansertib 40 mg/m^2 + Decitabine

Serious: 4/4 (100%)

Deaths: 3/4

Phase 1b: Onvansertib 60 mg/m^2 + Decitabine

Serious: 2/3 (67%)

Deaths: 3/3

Phase 1b: Onvansertib 90 mg/m^2 + Decitabine

Serious: 5/6 (83%)

Deaths: 4/6

Phase 2: Onvansertib 60 mg/m^2 + Decitabine

Serious: 27/32 (84%)

Deaths: 24/32

Serious adverse events (59 terms)

Reaction	System	Phase 1b: Onvansertib 12 m…	Phase 1b: Onvansertib 18 m…	Phase 1b: Onvansertib 27 m…	Phase 1b: Onvansertib 40 m…	Phase 1b: Onvansertib 60 m…	Phase 1b: Onvansertib 12 m…	Phase 1b: Onvansertib 18 m…	Phase 1b: Onvansertib 27 m…	Phase 1b: Onvansertib 40 m…	Phase 1b: Onvansertib 60 m…	Phase 1b: Onvansertib 90 m…	Phase 2: Onvansertib 60 mg…
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—
Lung infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Escherichia bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Septic shock	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Urine output decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—
Seroma	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—
Tumour lysis syndrome	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Neck pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Leukaemic infiltration pulmonary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—
Haemorrhage intracranial	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (157 terms — click to expand)

Reaction	System	Phase 1b: Onvansertib 12 m…	Phase 1b: Onvansertib 18 m…	Phase 1b: Onvansertib 27 m…	Phase 1b: Onvansertib 40 m…	Phase 1b: Onvansertib 60 m…	Phase 1b: Onvansertib 12 m…	Phase 1b: Onvansertib 18 m…	Phase 1b: Onvansertib 27 m…	Phase 1b: Onvansertib 40 m…	Phase 1b: Onvansertib 60 m…	Phase 1b: Onvansertib 90 m…	Phase 2: Onvansertib 60 mg…
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Lung infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Petechiae	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Oral pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—
Escherichia bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Febrile neutropenia, Acute myeloid leukaemia, Lung infection, Sepsis, Arthralgia, Pneumonia, Escherichia bacteraemia, Lower gastrointestinal haemorrhage.

Data from ClinicalTrials.gov NCT03303339 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The two sides of chromosomal instability: drivers and brakes in cancer.
Hosea R, Hillary S, Naqvi S, Wu S, et al · · 2024 · cited 102× · PMID 38553459 · DOI 10.1038/s41392-024-01767-7
Present and Future Perspective on PLK1 Inhibition in Cancer Treatment.
Chiappa M, Petrella S, Damia G, Broggini M, et al · · 2022 · cited 95× · PMID 35719948 · DOI 10.3389/fonc.2022.903016
Development of synthetic lethality in cancer: molecular and cellular classification.
Li S, Topatana W, Juengpanich S, Cao J, et al · · 2020 · cited 82× · PMID 33077733 · DOI 10.1038/s41392-020-00358-6
PLK1 inhibition-based combination therapies for cancer management.
Su S, Chhabra G, Singh CK, Ndiaye MA, et al · · 2022 · cited 81× · PMID 34973570 · DOI 10.1016/j.tranon.2021.101332
Management of Acute Myeloid Leukemia: Current Treatment Options and Future Perspectives.
Fleischmann M, Schnetzke U, Hochhaus A, Scholl S. · · 2021 · cited 44× · PMID 34830877 · DOI 10.3390/cancers13225722
The balance between mitotic death and mitotic slippage in acute leukemia: a new therapeutic window?
Ghelli Luserna di Rorà A, Martinelli G, Simonetti G. · · 2019 · cited 40× · PMID 31771633 · DOI 10.1186/s13045-019-0808-4
A novel PLK1 inhibitor onvansertib effectively sensitizes MYC-driven medulloblastoma to radiotherapy.
Wang D, Veo B, Pierce A, Fosmire S, et al · · 2022 · cited 39× · PMID 34477871 · DOI 10.1093/neuonc/noab207
Second-Generation Antimitotics in Cancer Clinical Trials.
Novais P, Silva PMA, Amorim I, Bousbaa H. · · 2021 · cited 37× · PMID 34371703 · DOI 10.3390/pharmaceutics13071011

Verify or expand the search:

Other trials of Onvansertib

Trials testing the same drug.

NCT06398587 — Onvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced, Unre · Phase 2 · withdrawn
NCT05549661 — Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MP · Phase 1 · recruiting
NCT05593328 — Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatmen · Phase 2 · completed
NCT05383196 — Onvansertib + Paclitaxel In TNBC · Phase 1, PHASE2 · active not recruiting
NCT05450965 — Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer · Phase 2 · recruiting

Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

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NCT07107126 — Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes · Phase 1 · recruiting

Other Cardiff Oncology trials

Trials by the same sponsor.

NCT05593328 — Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatmen · Phase 2 · completed
NCT04752696 — Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Part · Phase 2 · completed
NCT03829410 — Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patien · Phase 1, PHASE2 · completed
NCT03414034 — Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prosta · Phase 2 · completed
NCT04446793 — Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Muta · no longer available

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03303339 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cardiff Oncology
Last refreshed: 27 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03303339.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03303339

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (59 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Onvansertib

Other recruiting trials for Acute Myeloid Leukemia

Other Cardiff Oncology trials

Verify against primary sources