First in human study with ODM-207 in patients with selected advanced cancers to assess its safety and how the body affects it
- Conditions
- Advanced Solid TumoursMedDRA version: 19.0 Level: LLT Classification code 10065143 Term: Malignant solid tumour System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004826-32-ES
- Lead Sponsor
- Orion Corporation Orion Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 144
1. Written informed consent obtained
2. Male or female patients of age ?18 years
3. Life expectancy >12 weeks
4. Availability of tumour tissue sample
5. Patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy, or the patient actively refuses use of chemotherapy which would be regarded standard and/or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable.
8. Adequate haemopoietic, hepatic, renal and coagulation function. Functionality may be judged clinically adequate even if some of the measures deviate marginally from the followings. Such cases should be discussed with the medical monitor prior to making decision on eligibility.
• ANC = 1.5 x 109/l
• platelet count = 100 x 109/l
• haemoglobin = 9 g/dl in the absence of transfusions within 2 weeks before the start of study treatment
• bilirubin = 1.5 x upper limit of normal (ULN) and for patients with a diagnosis of Gilbert’s disease = 3 x ULN;
• AST and ALT = 3 x ULN; alternatively = 5 x ULN may be accepted if liver metastases are present after agreement with the sponsor and the medical monitor
• albumin = 3.0 g/dl
• serum creatinine = 1.5 x ULN or calculated creatinine clearance = 60 ml/min/1.73 m2 for patients with creatinine levels above normal limit.
• adequate coagulation function as defined by partial thromboplastin time (PTT) = 1.5 ULN
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Patients with an ECOG of 2 who are considered to have significantly greater likelihood of response to ODM-207 (e.g. based on mechanism of action, biomarker information, ex-vivo pre-screening or other supporting evidence) may be considered eligible if otherwise judged clinically eligible. Such cases should be discussed with the medical monitor prior to making decision on eligibility.
10. Recovery from adverse events of previous systemic anti-cancer therapies to normal or grade 1 level except for alopecia or stable neuropathy of grade 2 induced by prior cancer treatment.
Diagnosis-specific criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 72
1. History of bleeding disorder or significant bleeding episode (e.g. from the gastrointestinal tract) within 6 months prior to study treatment.
2. Patients receiving anticoagulants (e.g. warfarin) or medications that durably inhibit platelet function (e.g. aspirin, clopidogrel, tirofiban). Wash-out period for these agents is 7 days prior to study treatment. Use of low molecular weight heparins (LMWH) is allowed if the patient has a stable coagulation profile.
3. History or current leptomeningeal or brain metastasis or spinal cord compression.
Patients previously treated for these conditions that have had stable CNS disease for >1 month, are asymptomatic and off corticosteroids, or are on stable dose of corticosteroids for at least 1 month prior to study Day 1 are permitted in Part 1B and Part 2 of the study.
4. Significant cardiovascular conditions or circumstances as listed below. The condition may be judged not clinically significant even if it deviates marginally from the following criteria. Such cases should be discussed with the medical monitor prior to making decision on eligibility.
• Active or unstable cardio/cerebro-vascular disease including thromboembolic event. Examples include recent (within 6 months) myocardial infarction, coronary artery bypass graft or symptomatic cerebrovascular accident, or congestive heart failure (New York Heart Association class III-IV).
• Uncontrolled hypertension: systolic blood pressure (BP) = 160 mmHg or diastolic BP = 90 mmHg with optimised antihypertensive therapy.
• History of severe arrhythmia, familial arrhythmia, clinically significant conduction abnormality or congenital long QT syndrome.
• Repeatable prolongation of QTcF interval = 450 ms in 2 out of 3 recordings or any clinically significant abnormality in the ECG at screening period.
• Concomitant therapies known to prolong QT interval and associated with a risk of Torsades de Pointes (TdP) are not permitted between 7 days before the first dose and until last study treatment dose. Amiodarone is not permitted for 90 days before the first dose of ODM-207.
• In Part 1A only, patients with ventricular pacemaker or left bundle branch block.
5. Patients who received systemic anticancer treatment before the first dose of study treatment within the following time-frames given that treatment related AEs have been resolved to at least grade 1. Luteinizing hormone-releasing hormone [LHRH] agonists or antagonists are allowed.
• less than 21 days since the last dose of anticancer chemotherapy or less than 5 half-lives of a small molecule, whichever is the shorter
• less than 6 weeks since the last dose of immunotherapy antibody therapies or Mitomycin C or nitrosoureas
• less than 28 days of wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) or 14 days of limited field radiation for palliation.
6. Major surgery or serious infection within 21 days of the first dose of study treatment or known history of HIV or hepatitis B or C infection.
7. Known gastrointestinal disease or a procedure that may affect absorption of study treatment. Use of acid-reducing agents such as proton-pump inhibitors, H2-receptor antagonists, or antacids is allowed.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method