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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01455584
First received: October 18, 2011
Last updated: May 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Advanced Solid Malignancies
 Drug: HM781-36B tablets
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • MTD determination [ Time Frame: Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: June 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HM781-36B
HM781-36B
 Drug: HM781-36B tablets
Q1X28D/4W for HM781-36B tablets
Other Name: HM781-36B

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
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455584

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

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01455584     History of Changes
Other Study ID Numbers: HM-PHI-102
Study First Received: October 18, 2011
Last Updated: May 22, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanmi Pharmaceutical Company Limited:
HM781-36B

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013