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Cell Cycle Inhibitor
Onvansertib + Paclitaxel for Breast Cancer
Phase 1 & 2
Recruiting
Led By Antonio C Giordano, MD, PhD
Research Sponsored by Antonio Giordano, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically-confirmed triple negative breast cancer (defined as ER ≤ 10%, PR ≤ 10%, Her-2-neu negative per ASCO/CAP 2018 guidelines: 0-1+ by IHC or FISH-negative)
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks until disease progression, in average 24 weeks
Awards & highlights
Study Summary
This trial is being done to see if Onvansertib in combination with Paclitaxel is safe and effective in treating TNBC that has spread to other parts of the body.
Who is the study for?
Adults with advanced triple-negative breast cancer (TNBC) that has spread, who are in good physical condition and haven't had more than three chemotherapy treatments for metastatic disease. They must not be pregnant or breastfeeding, have no severe allergies to paclitaxel, and agree to use contraception during the study.Check my eligibility
What is being tested?
The trial is testing the combination of Onvansertib with Paclitaxel to see if it's safe and effective against TNBC that has metastasized. Participants will receive both drugs; Onvansertib is taken orally while Paclitaxel is given intravenously.See study design
What are the potential side effects?
Possible side effects include allergic reactions, nerve damage (neuropathy), fatigue, digestive issues like nausea or diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, liver function changes, and muscle aches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is triple negative.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My breast cancer is advanced, cannot be surgically removed, and may have spread.
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My blood tests show my organs are functioning well.
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I cannot be on hormone therapy if my cancer is hormone receptor positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 8 weeks until disease progression, in average 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks until disease progression, in average 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-Limiting Toxicity (DLT)-Phase Ib
Therapeutic procedure
Overall Response Rate (ORR) Phase II
Secondary outcome measures
AUC-Phase Ib
Cmax-Phase Ib
Incidence of Grade 3 or Higher Treatment-Related Toxicity-Phase II
+1 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%
Ear pain
6%
Lower gastrointestinal haemorrhage
6%
Fluid overload
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%
Hyperglycaemia
3%
Atrial fibrillation
3%
Myalgia
3%
Back pain
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
2Treatment groups
Experimental Treatment
Group I: DOSE EXPANSION RP2D ONVANSERTIB + PACLITAXELExperimental Treatment2 Interventions
The study is divided into three time periods: a screening period; a treatment period; and a post-treatment follow-up period.
The names of the study interventions involved in this study are:
Onvansertib
Paclitaxel
Group II: DOSE ESCALATION ONVANSERTIB + PACLITAXELExperimental Treatment2 Interventions
In the phase 1b, dose escalation/de-escalation will be managed using a BOIN design to identify the RP2D.
The study is divided into three time periods: a screening period; a treatment period; and a post-treatment follow-up period.
The names of the study interventions involved in this study are:
Onvansertib
Paclitaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Onvansertib
2017
Completed Phase 2
~220
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Antonio Giordano, MDLead Sponsor
Cardiff OncologyIndustry Sponsor
10 Previous Clinical Trials
569 Total Patients Enrolled
Antonio C Giordano, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is triple negative.I am 18 years old or older.I agree to use birth control or avoid pregnancy during and for 6 months after the study.I am not on any cancer treatments but may be in surveys or studies.I have had more than 3 chemotherapy treatments for my advanced cancer.I cannot or do not want to take pills.I am fully active or can carry out light work.I will be taking medications that can affect my heart's rhythm.I do not have an active COVID-19, HIV, or hepatitis infection, or my HIV is well-controlled.My brain metastases are stable, and I'm not on steroids.I am not taking strong CYP3A4 inhibitors or inducers.My breast cancer is advanced, cannot be surgically removed, and may have spread.I have risk factors for a specific heart rhythm issue or low potassium levels.I have had cancer before, but it was either skin cancer treated well, cervical cancer treated in its early stage, or any cancer treated over 2 years ago with no signs of return.I do not have any serious ongoing illnesses that would affect my participation.My blood tests show my organs are functioning well.I have moderate to severe numbness, tingling, or pain in my hands or feet.I am not pregnant or breastfeeding.I have significant fluid buildup in my abdomen or around my lungs.You are allergic to paclitaxel.I haven't had chemotherapy or biologic therapy in the last 21 days or 5 half-lives, whichever is shorter.I received palliative radiation therapy less than 2 weeks ago.I do not have severe GI issues that could affect medication absorption.I have not had major surgery in the last 6 weeks.My heart's electrical cycle is longer than normal, even after correction.I do not have any health conditions that would make the study treatment unsafe for me.My cancer returned or worsened within 6 months after my last taxane-based treatment.I cannot be on hormone therapy if my cancer is hormone receptor positive.
Research Study Groups:
This trial has the following groups:- Group 1: DOSE ESCALATION ONVANSERTIB + PACLITAXEL
- Group 2: DOSE EXPANSION RP2D ONVANSERTIB + PACLITAXEL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for this clinical trial?
"Yes, this is an ongoing clinical trial that was originally posted on September 30th, 2020. The most recent update to the listing was made on October 25th, 2020."
Answered by AI
What are the goals of this clinical trial?
"This clinical trial will aim to assess the Dose-Limiting Toxicity (DLT) during the first cycle of therapy, which lasts 28 days. The secondary outcomes include Cmax and AUC, which are measures of the maximum concentration and area under the curve of the drug respectively. Finally, the study will also look at Median Progression-free survival (PFS), which is defined as the duration of time from study entry until disease progression or death."
Answered by AI
How many individuals are being cared for in this clinical trial?
"Yes, this is an active recruitment according to the listing on clinicaltrials.gov. The original posting date was September 30th, 2022 and there have been recent edits made on October 25th, 2022. They are looking for a total of 50 subjects that will be split evenly between 3 locations."
Answered by AI
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