Trials / Unknown
UnknownNCT04149691
Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies
A Phase I, Open-label, Multicentre, Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- Sponsor
- Celon Pharma SA · Industry
- Sex
- All
- Age
- 25 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to determine to evaluate safety and tolerability of CPL304110 when administered once daily to adults with advanced solid malignancies.
Detailed description
01FGFR2018 is an Open-label, Multicentre, Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects with Advanced Solid Malignancies. The study consists of 3 parts: initial dose escalation (Part 1 - without FGFR, fibroblast growth factor receptor, molecular aberrations), dose escalation (Part 2 - with FGFR molecular aberrations) and dose extension (Part 3 - with FGFR molecular aberrations).
Conditions
- Gastric Cancer
- Bladder Cancer
- Squamous Non-small Cell Lung Cancer
- Cholangiocarcinoma
- Sarcoma
- Endometrial Cancer
- Other Solid Tumours
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CPL304110 | CPL304110 is to be administered orally as hard gelatine capsules once daily in 28-day cycles. |
Timeline
- Start date
- 2019-07-19
- Primary completion
- 2024-06-01
- Completion
- 2024-06-01
- First posted
- 2019-11-04
- Last updated
- 2024-02-07
Locations
7 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT04149691. Inclusion in this directory is not an endorsement.