Trials / Unknown
UnknownNCT02314884
Phase I Trial to Investigate Cafusertib Hydrochloride Monotherapy in Chinese Patients With Advanced Solid Tumours
A Phase I, Open-label, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of Cafusertib Hydrochloride in Patients With Advanced Solid Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A Phase I, Open-label, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of Cafusertib Hydrochloride in Patients With Advanced Solid Tumors
Detailed description
To investigate safety, tolerability of cafusertib in Chinese patients with Advanced Solid Tumors that are not eligible for conventional or intensive treatment. The dose of cafusertib will be escalated to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cafusertib in advanced cancer patients. At the same time, pharmacokinetic characteristics and preliminary efficacy of cafusertib will be observed in advanced cancer patients. To determine the recommended dosage regimen for phase II.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cafusertib Hydrochloride |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2015-12-01
- Completion
- 2016-02-01
- First posted
- 2014-12-11
- Last updated
- 2014-12-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02314884. Inclusion in this directory is not an endorsement.