Trials / Completed
CompletedNCT02405065
Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573
Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573 in Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Hanmi Pharmaceutical Company Limited · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose of HM95573.
Detailed description
Besides the main objective, there are 3 other objectives as follows: * To evaluate the anti-cancer effect of HM95573 in solid tumor patients * To investigate the pharmacokinetic profile of HM95573 after oral administration. * To investigate biomarkers related to the safety and efficacy of HM95573.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HM95573 | BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops |
Timeline
- Start date
- 2015-01-12
- Primary completion
- 2017-01-18
- Completion
- 2018-05-16
- First posted
- 2015-04-01
- Last updated
- 2020-08-10
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02405065. Inclusion in this directory is not an endorsement.