Trials / Unknown
UnknownNCT01226407
Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile
Phase I Study of CG200745 to Examine the Maximum Tolerate Dose, Pharmacokinetic and Pharmacodynamic Profiles, and Safety Among Patients With Progressive Solid Cancer
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- CrystalGenomics, Inc. · Industry
- Sex
- All
- Age
- 20 Years – 69 Years
- Healthy volunteers
- Not accepted
Summary
Open label, single dose and phase I study. The primary objective: To determine the maximum tolerated dose in Single dose The secondary objective: to evaluate the toxicity in administration to determine desirable dosing amount for phase II to evaluate tumor response in progressive solid cancer patients to evaluate pharmacokinetic/ pharmacodynamic profile.
Detailed description
1. Number of Subjects: 28\~36, dose escalation (2\~6 subject of each step) 2. Adverse Events will be coded to preferred therm and body system using the CTCAE
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CG200745 | Multiple administration (IV) over the cycles untile MTD/LTD |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2013-02-01
- Completion
- 2013-02-01
- First posted
- 2010-10-22
- Last updated
- 2012-12-31
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01226407. Inclusion in this directory is not an endorsement.