Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Patients With Advanced Solid Malignancies

Sponsor
Hanmi Pharmaceutical Company Limited
Study ID
NCT00979563
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Malignancies

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The main objective of this study is to determine the maximum tolerated dose (MTD) of OratecanTM. Eligible subjects of this study are patients with histologically or cytologically confirmed malignant solid tumor refractory to standard therapy or for which no established therapy exists at the time of study participation.

Key Dates

Start date
Jul 31, 2008
Status verified
Sep 2009
Primary completion
Mar 31, 2010
Completion
Nov 30, 2010

Study Design

Enrollment
15 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Toxicity evaluation (safety evaluation): Toxicity will be evaluated by medical history, vital signs, physical examination and laboratory tests performed during the screening period (D-28 to D0) and treatment period based on NCI-CTCAE (version 3.0). [ Time Frame: Toxicity will be evaluated on Day 21 during Cycle 1 ]

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