Clinical Trial to Determine the MTD of HM781-36B in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01455584
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : May 23, 2013
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
The main objective of this study is to determine the maximum tolerated dose (MTD) of HM781-36B continuously.

Condition or disease Intervention/treatment Phase
Advanced Solid Malignancies Drug: HM781-36B tablets Phase 1

Detailed Description:

Besides the main objective, there are 4 other objectives as follows:

  1. To determine dose-limiting toxicity (DLT) of HM781-36B
  2. To determine Maximum Tolerated Dose (MTD) of HM781-36B
  3. To determine the effect of food on the pharmacokinetics after dosed HM781-36B continuously
  4. To evaluate anticancer activity of HM781-36B in patients with advanced solid malignancies

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ⅰ Study to Determine the Maximum Tolerated Dose of HM781-36B Continuously Given in Patients With Advanced Solid Tumors and to Assess the Food Effect on Pharmacokinetic Profile
Study Start Date : June 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Arm Intervention/treatment
Experimental: HM781-36B
Drug: HM781-36B tablets
Q1X28D/4W for HM781-36B tablets
Other Name: HM781-36B

Primary Outcome Measures :
  1. MTD determination [ Time Frame: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1 ]

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically or cytologically confirmed advanced solid tumor
  2. Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy
  3. Previous chemotherapy, radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved
  4. Aged ≥19
  5. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
  6. A life expectancy greater than 12 weeks
  7. Adequate bone marrow, renal and liver function.
  8. Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures

Exclusion Criteria:

  1. Patients with hematopoietic malignancies,uncontrolled infection, CNS metastasis.
  2. Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT
  3. Patients who have GI malabsorption or difficulty taking oral medication
  4. Patients who have psychiatric or congenital disorder
  5. Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments
  6. Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01455584

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited

Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT01455584     History of Changes
Other Study ID Numbers: HM-PHI-102
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: April 2013

Keywords provided by Hanmi Pharmaceutical Company Limited: