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

Sponsor
Hanmi Pharmaceutical Company Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT01455584
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
23
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Jun 1, 2011
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: HM781-36B

HM781-36B

Drug: HM781-36B tablets
Q1X28D/4W for HM781-36B tablets
Other Names:
  • HM781-36B

    		•

    Outcome Measures

    Primary Outcome Measures

    1. MTD determination [Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Hanmi Pharmaceutical Company Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hanmi Pharmaceutical Company Limited
    ClinicalTrials.gov Identifier:
    NCT01455584
    Other Study ID Numbers:
    • HM-PHI-102
    First Posted:
    Oct 20, 2011
    Last Update Posted:
    May 23, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by Hanmi Pharmaceutical Company Limited
    HM781-36B
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of May 23, 2013