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Hormone Therapy
Onvansertib for Prostate Cancer
Phase 2
Waitlist Available
Research Sponsored by Cardiff Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 months
Awards & highlights
Study Summary
This trial is testing a new drug to see if it's safe and effective for treating prostate cancer that has spread and is no longer responding to other treatments.
Eligible Conditions
- Metastatic Castration Resistant Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 20 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 20 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Lack of Prostate-specific Antigen (PSA) Progression per Prostate Cancer Working Group 3 (PCWG3) Criteria After 12 Weeks
Secondary outcome measures
Absolute Change from Baseline in PSA Response
Maximal Percentage Change from Baseline in PSA
Number of Participants With Adverse Events per Common Terminology Criteria for Adverse Events (CTCAE)
+6 moreSide effects data
From 2021 Phase 1 & 2 trial • 72 Patients • NCT0330333938%
Febrile neutropenia
31%
Hypokalaemia
28%
Diarrhoea
28%
Stomatitis
25%
Fatigue
22%
Nausea
22%
Epistaxis
19%
Oedema peripheral
19%
Platelet count decreased
19%
Alopecia
16%
Hypophosphataemia
16%
Acute myeloid leukaemia
16%
Sepsis
16%
Dyspnoea
16%
Cough
16%
Hypoalbuminaemia
13%
Hypoxia
13%
Lung infection
13%
Anaemia
13%
Rash maculo-papular
13%
Rash
13%
Hypocalcaemia
13%
Arthralgia
13%
Hypertension
13%
Hypotension
9%
Electrocardiogram QT prolonged
9%
Syncope
9%
Pneumonia
9%
Cellulitis
9%
Headache
9%
Abdominal pain upper
9%
Oral pain
9%
Staphylococcal infection
9%
Urinary tract infection
9%
Hypomagnesaemia
9%
Dizziness
9%
Oropharyngeal pain
9%
Petechiae
9%
Decreased appetite
9%
Alanine aminotransferase increased
9%
Abdominal pain
9%
Escherichia bacteraemia
9%
Blood creatine increased
9%
Mucosal inflammation
9%
Hyperbilirubinaemia
9%
Pleural effusion
9%
Vomiting
6%
Dry mouth
6%
Lower gastrointestinal haemorrhage
6%
Fluid overload
6%
Ear pain
6%
Dry skin
6%
Oral candidiasis
6%
Neuropathy peripheral
6%
Fall
6%
Pyrexia
6%
Nasal congestion
6%
Ecchymosis
6%
Blood alkaline phosphatase
6%
Insomnia
6%
Pain in extremity
6%
Haematemesis
6%
Odynophagia
6%
Proctalgia
6%
Staphylococcal bacteraemia
6%
Bacteraemia
6%
Pneumonia fungal
6%
Pruritus
6%
Dermatitis contact
6%
Purpora
6%
Non-cardiac chest pain
6%
Hyperkalaemia
6%
Hypercalcaemia
6%
Flank pain
6%
Aspartate aminotransferase increased
6%
Neutrophil count decreased
6%
Blood bilirubin increased
6%
Pleuritic pain
6%
Haematoma
6%
Conjunctival haemorrhage
3%
Back pain
3%
Myalgia
3%
Atrial fibrillation
3%
Hyperglycaemia
3%
Tumour lysis syndrome
3%
Mallory-Weiss syndrome
3%
Upper gastrointestinal haemorrhage
3%
Pain
3%
Respiratory failure
3%
Rash pruritic
3%
Musculoskeletal pain
3%
Face oedema
3%
Hyponatraemia
3%
Contusion
3%
Septic shock
3%
Candida infection
3%
Granulicatella bacteraemia
3%
Kidney infection
3%
Pancytopenia
3%
Colitis
3%
Melaena
3%
Constipation
3%
Transfusion reaction
3%
Dysgeusia
3%
Dyspnoea exertional
3%
Wheezing
3%
Neutropenia
3%
Weight decreased
3%
Anxiety
3%
Eye pruritus
3%
White blood cell count decreased
3%
Neutropenic colitis
3%
Mental status changes
3%
Chills
3%
Sinus tachycardia
3%
Haemoptysis
3%
Aphasia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: Onvansertib 60 mg/m^2 + Decitabine
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C: onvansertib + abiraterone and prednisoneExperimental Treatment3 Interventions
On Day 1 of each cycle, onvansertib will be administered orally (PO) once daily (QD) at a dose of 12 mg/m^2 for 14 days (Day 1 through Day 14) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants will also receive abiraterone and prednisone.
Group II: Arm B: onvansertib + abiraterone and prednisoneExperimental Treatment3 Interventions
On Day 1 of each cycle, onvansertib will be administered orally (PO) once daily (QD) at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 14-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants will also receive abiraterone and prednisone.
Group III: Arm A: onvansertib + abiraterone and prednisoneExperimental Treatment3 Interventions
On Day 1 of each cycle, onvansertib will be administered orally (PO) once daily (QD) at a dose of 24 mg/m^2 for 5 days (Day 1 through Day 5) out of a 21-day cycle. Beginning on Day 1 and continuing uninterrupted throughout each cycle, participants will also receive abiraterone and prednisone. This arm was discontinued.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Onvansertib
2017
Completed Phase 2
~220
Abiraterone
2012
Completed Phase 4
~2830
Find a Location
Who is running the clinical trial?
Cardiff OncologyLead Sponsor
10 Previous Clinical Trials
547 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please provide more context around Onvansertib research?
"There are currently 380 ongoing clinical trials studying Onvansertib. 101 of those trials are in Phase 3, which is the last stage before FDA approval can be considered. However, most of these studies are based out of Duarte, California - with a total of 17187 locations running active research for this medication."
Answered by AI
Are there any harmful side effects associated with Onvansertib?
"Onvansertib's safety is estimated as a 2. This rating comes from the fact that, while there are Phase 2 trials supporting its safety, there are none attesting to its efficacy."
Answered by AI
What are some of the main indications for Onvansertib?
"Onvansertib can be used to manage thyroiditis, ulcerative colitis, and cancerous neoplasms."
Answered by AI
How many people are participating in this research project?
"Unfortunately, this particular clinical trial is no longer seeking participants. It was initially posted on June 18th, 2018 but the most recent update to the listing was on July 13th, 2022. However, there are 1297 other trials for prostate cancer and 380 for Onvansertib that are still looking for patients."
Answered by AI
Are there any open positions for people who want to participate in this clinical trial?
"Unfortunately, this study has already completed recruitment. The listing was first posted on June 18th, 2018 and updated for the last time on July 13th, 2022. There are currently 1297 other studies enrolling patients with prostate cancer and 380 trials involving Onvansertib that are actively seeking participants."
Answered by AI
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