Examine Maximum Tolerated Dose and Pharmacokinetic and Pharmacodynamic Profile

CrystalGenomics

Status and phase: Unknown; Phase 1

Conditions: Solid Tumour

Treatments: Drug: CG200745

Study type: Interventional

Funder types: Industry

Identifiers

NCT01226407

CG200745-1-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 36 estimated patients

Sex: All

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• from 20 years old to 69 years old
• diagnosed with progressive solid cancer
• In spite of standard chemotherapies, the efficacy of the treatment or life extension cannot be expected.
• Evaluated 0-1 of ECOG
• Expected life duration is within 3 months

Exclusion criteria

• Major surgery except tumor-removal surgery received within 2 weeks of screening.
• history of CNS metasis
• hyper-sensitivy of study drug
• pregancy or lactating
• administered other HDAC inhibitor within 4 weeks of screening

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Single Arm for CG200745

Experimental group

Description:

any progrossive solid cancer

Treatment:

Drug: CG200745