Trials / Completed
CompletedNCT03604679
SyB C-0501(Oral Bendamustine) in Patients With Advanced Solid Tumors
A Multicenter, Open-label, Phase I Study of SyB C-0501(Oral Bendamustine) in Patients With Advanced Solid Tumors:
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- SymBio Pharmaceuticals · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
This study is an open-label, multicenter, phase 1 study of SyB C-0501 by continuous daily oral administration in patients with advanced solid tumors, who have previously received anticancer therapy and consists of two parts. Part 1 is a dose escalation study to evaluate tolerability of SyB C-0501 in the patients, and to find the maximum tolerated dose (MTD), recommended dose (RD) and optimum dosing schedule. Part 2 is being done to evaluate safety and anti-tumor activity of SyB C-0501 preliminarily at RD, and to assess its target cancer exploratory.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SyB C-0501 | Specified dose on specified days |
Timeline
- Start date
- 2018-05-24
- Primary completion
- 2020-09-11
- Completion
- 2020-09-11
- First posted
- 2018-07-27
- Last updated
- 2021-04-27
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03604679. Inclusion in this directory is not an endorsement.