Clinical trial • Phase III • Oncology
sorafenib for Hepatocellular carcinoma | Renal cell carcinoma | Differentiated thyroid carcinoma
Phase III trial of sorafenib for Hepatocellular carcinoma | Renal cell carcinoma | Differentiated thyroid carcinoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Hepatocellular carcinoma | Renal cell carcinoma | Differentiated thyroid carcinoma
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-06-2024
- First CTIS Authorization Date
- 27-08-2024
Trial design
Randomised, open-label, dph001 (amorphous formulation of sorafenib in mesoporous magnesium carbonate) versus nexavar (sorafenib); dose and schedule not specified.-controlled, crossover Phase III trial across 1 site in Sweden.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- DPH001 (amorphous formulation of sorafenib in mesoporous magnesium carbonate) versus Nexavar (sorafenib); dose and schedule not specified.
- Crossover
- Yes
- Target Sample Size
- 20
Eligibility
Recruits 20 No vulnerable populations selected; consent/assent handling not specified..
- Vulnerable Population
- No vulnerable populations selected; consent/assent handling not specified.
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 2
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 20
Sweden
- Earliest CTIS Part Ii Submission Date
- 06-08-2024
- Latest Decision Or Authorization Date
- 27-08-2024
- Processing Time Days
- 21
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- CTC Clinical Trial Consultants AB
- Department Name
- CTC
- Contact Person Name
- Björn Schultze
- Contact Person Email
- bjorn.schultze@ctc-ab.se
- Number Of Participants
- 20
Sponsor
Primary sponsor
- Full Name
- Disruptive Pharma AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- DPH001 (amorphous formulation of sorafenib in mesoporous magnesium carbonate)
- Active Substance
- sorafenib
- Modality
- Small molecule
- Investigational Product Name
- Nexavar (sorafenib)
- Active Substance
- sorafenib
- Modality
- Small molecule
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