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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


Phase 1
19 Years
N/A
Not Enrolling
Both
Advanced Solid Malignancies

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Trial Information

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


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


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.)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD determination

Outcome Time Frame:

Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1

Safety Issue:

Yes

Authority:

Korea: Food and Drug Administration

Study ID:

HM-PHI-102

NCT ID:

NCT01455584

Start Date:

June 2011

Completion Date:

May 2013

Related Keywords:

  • Advanced Solid Malignancies
  • HM781-36B
  • Neoplasms

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