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

Phase 1

Completed

• Conditions: Advanced Solid Malignancies
• Interventions: Drug: HM781-36B tablets

• Registration Number: NCT01455584
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Status Verified: 2013-04
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-22
• Last Update Posted: 2013-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HM781-36B	HM781-36B tablets	HM781-36B

Primary Outcome Measures

Name	Time	Method
MTD determination	Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of