An ascending single and multiple dose study of the safety, tolerability, pharmacokinetics and anti-tumour activity of once-daily oral treatment with EO1001 in patients with advanced cancer.
- Conditions
- ErbB-1(EGFR) positive cancerErbB-2(HER2) positive cancerERbB-4 (HER4) positive cancerCancer - Any cancer
- Registration Number
- ACTRN12620000583943
- Lead Sponsor
- Senz Oncology Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
•Male or female >= 18 years of age participants with confirmed diagnosis of metastatic or advanced stage ErbB-1 (EGFR), ErbB-2 (HER2) and/or ERbB-4 (HER4) positive cancer who have relapsed after treatment with approved therapies and are unsuitable for further treatment with approved therapies or declined further treatment with approved therapies.
•Participants must sign informed consent.
•Participants must have measurable disease, defined as at least 1 unidimensional measurable lesion on an imaging scan as defined by RECIST 1.1.
•Life expectancy of greater than 3 months.
•Acceptable organ function, as evidenced by the following laboratory data during screening period:
•Adequate hepatic function as defined by bilirubin less than or equal to 1.5 x the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN. Serum bilirubin must be less than or equal to 2.5 mg/dL when increase is clearly documented as due to Gilbert’s syndrome.
•Adequate renal function, with serum creatinine less than or equal to 1.5 x ULN or MDRD greater than or equal to 60 mL/min (CKD EPI Creatinine Equation).
oCNS metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement may be enrolled provided they are stable as shown by CT/MRI scan at least 4 weeks before screening without evidence of cerebral oedema.
oPatients with CNS metastases requiring corticosteroids or anticonvulsants must be on a stable or declining dose for a minimum of 10 days prior to cycle 1 day 1
oPatients with leptomeningeal disease may be allowed in the study in agreement with sponsor and medical monitor.
•Active infection requiring systemic treatment, defined as requiring antimicrobial, antifungal, or antiviral agents.
•Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
•Untreated or symptomatic brain metastases. Participants with treated or untreated brain metastases are NOT eligible if there has been a change in brain disease status in the 8 weeks prior to screening. This includes evidence of radiological progression, clinical decline and increasing steroid dose.
•Current or recent (within 10 days of Cycle 1 Day 1) use of full dose oral or parenteral anticoagulants or other thrombolytic agents for therapeutic (as opposed to prophylactic) purposes, clinically serious non-healing wounds, or incompletely healed bone fracture.
•Participants on > 2mg dexamethasone (or steroid equivalent).
•Ventriculoperitoneal (VP) shunts.
•Renal compromised or renal failure.
•Hepatic compromised or hepatic failure.
•Bullous and exfoliative skin disorders.
•Interstitial lung disease (ILD)
•Participants with adequate cardiac function ( less than or equal to NYHA class II) or normal cardiac function with left ventricular ejection fraction (LVEF) less than or equal to 50% at screening.
•Anticancer therapy within 4 weeks, or a minimum of 5 half-lives whichever is longer.
•Pregnancy or breast-feeding.
•Inability to swallow oral medications or having malabsorption syndrome.
•Unresolved adverse reactions to prior treatments NCI CTCAEv5 > Grade 1.
•Any serious medical or psychiatric conditions which the Investigator feels may interfere with the patient’s ability to give informed consent or participate in the procedures or evaluations of the study.
•Abnormal coagulation not corrected by plasma infusion (APTT > ULN or INR> 1.2).
•Participants of childbearing potential who do not agree to use at least 2 effective contraceptive methods throughout the study and for 6 months following completion of treatment.
•Female participants who are pregnant or lactating.
•Unstable angina or acute myocardial infarction less than or equal to 6 months prior to starting study treatment.
•Baseline QTc greater than or equal to 470 msec
•Cardiomyopathy.
•Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To examine the safety and tolerability of EO1001 in participants with metastatic or advanced stage ErbB-1(EGFR), ErbB-2(HER2) and/or ERbB-4 (HER4) positive cancer..<br><br>Safety and tolerability will be measured by serum blood tests and patient feedback. All adverse events will be captured in the patient files and the EDC. [Safety and tolerability for cycle 1 will be assessed daily for 7 days and then weekly until day 28. For Cycle 2 to Cycle 6 safety and tolerability will be assessed every 28 days.<br><br>Overall Safety and tolerability will be assessed at the end of study visit iie 26 weeks post enrolment.]
- Secondary Outcome Measures
Name Time Method