Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Patients With Advanced Solid Malignancies (Oratecan-102)

Sponsor
Hanmi Pharmaceutical Company Limited
Study ID
NCT00986843
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. The irinotecan hydrochloric acid (HCl) tablet is escalated and administered per body surface area (BSA). The dose of HM30181A 60 mg is fixed. The Route of administration of irinitecan and HM30181A is oral. Each cycle consists of 21 days. Drugs are administered daily for 10 consecutive days (D1, 2, 3, 4, 5, 8, 9, 10, 11 and 12) followed by a washout of 9 days.

Key Dates

Start date
Jun 30, 2008
Status verified
Apr 2013
Primary completion
Feb 28, 2010
Completion
Sep 30, 2012

Study Design

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

Arms

  • Experimental: HM30181AK tablet + Irinotecan tablets
    HM30181AK tablet + Irinotecan tablets

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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