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.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Malignancies
• Intervention / Treatment: Drug: HM781-36B tablets

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
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HM781-36B	Drug: HM781-36B tablets; Q1X28D/4W for HM781-36B tablets; Other Names: HM781-36B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MTD determination	Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 18, 2011
• First Submitted That Met QC Criteria: October 19, 2011
• First Posted (Estimate): October 20, 2011

Study Record Updates

• Last Update Posted (Estimate): May 23, 2013
• Last Update Submitted That Met QC Criteria: May 22, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: HM781-36B
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HM-PHI-102