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

Advanced Solid Malignancies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455584
• Other study ID #: HM-PHI-102
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2011
• Last updated: May 22, 2013
• Start date: June 2011
• Est. completion date: May 2013

Study information

• Verified date: April 2013
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Advanced Solid Malignancies

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD determination		Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1