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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03035591 |
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Date of registration:
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20/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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ODM-207 in Patients With Advance Solid Tumours
BETIDES |
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Scientific title:
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Safety and Pharmacokinetics of ODM-207 in Patients With Selected Advanced Solid Tumours: an Open-label, Non-randomised, Uncontrolled, Multicentre, First-in-human Study With Cohort Expansion |
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Date of first enrolment:
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December 22, 2016 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03035591 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Finland
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Contacts
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Name:
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Johann De Bono |
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Address:
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Telephone:
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Email:
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Affiliation:
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ICR/Royal Marsden |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
- Life expectancy >12 weeks
- Patient may have either measurable or non-measurable disease, but must have disease
that can be evaluated for improvement of progression
- ECOG performance status of 0 to 1
Exclusion Criteria:
- History of bleeding disorder or significant bleeding episode within 6 months prior to
study treatment
- Subjects receiving anticoagulants or medications that durably inhibit platelet
function (7-day wash-out prior to study treatment)
- History of or current leptomeningeal or brain metastasis or spinal cord compression.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Solid Tumors
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Intervention(s)
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Drug: ODM-207
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Primary Outcome(s)
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Maximum Tolerated Dose
[Time Frame: 28 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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