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

October 18, 2011
October 20, 2011
May 23, 2013
June 2011
May 2013   (Final data collection date for primary outcome measure)
MTD determination [ Time Frame: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1 ]
Same as current
Complete list of historical versions of study NCT01455584 on Archive Site
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Clinical Trial to Determine the MTD of HM781-36B in Patients With Advanced Solid Tumors
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
The main objective of this study is to determine the maximum tolerated dose (MTD) of HM781-36B continuously.

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
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Malignancies
Drug: HM781-36B tablets
Q1X28D/4W for HM781-36B tablets
Other Name: HM781-36B
Experimental: HM781-36B
Intervention: Drug: HM781-36B tablets
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2013
May 2013   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Hanmi Pharmaceutical Company Limited
Hanmi Pharmaceutical Company Limited
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Hanmi Pharmaceutical Company Limited
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP