Phase I Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of HM781-36B in Patients With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

Phase I Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of HM781-36B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455571
• Other study ID #: HM-PHI-101
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2011
• Last updated: February 24, 2014
• Start date: November 2009
• Est. completion date: January 2013

Study information

• Verified date: February 2014
• 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.

Description:

Besides the main objective, there are 3 other objectives as follows:

1. To determine dose-limiting toxicity (DLT) of HM781-36B

2. To characterize the pharmacokinetics of HM781-36B, following oral administration of HM781-36B

3. To evaluate anticancer activity of HM781-36B in patients with advanced solid malignancies Groups of 3 patients per cohort or dose level will be treated with escalating doses of HM781-36B

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2013
• Est. primary completion date: January 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 (WBC=4,000/mm3 platelet=100000/mm3, hemoglobin=9.0g/dl and ANC= 1500/mm3, renal (Creatinine=1.5mg/dl) and liver function (AST/ALT/ALP = 3 x upper limit of normal and total bilirubin=2mg/dl) and no abnormal heart and lung function However, AST/ALT/ALP = 5 x upper limit of normal for patients with liver metastases and ALP level = 5 x upper limit of normal for patients with bone metastases are allowed 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, ileus, CNS metastasis.

2) Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT 3) Class III or IV heart failure (NYHA Class) or LVEF<40% 4) Patients who have GI malabsorption or difficulty taking oral medication 5) Patients who have psychiatric or congenital disorder 6) Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments 7) Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.) 8) Subjects who have no intention of following the requirements of the protocol or the follow-up management. Subjects who cannot be followed up regularly due to psychological, social, family, logistic, and geographical reasons 9) Subjects who were administered with other investigational products within 30 days before screening.

10) Subjects who, in the investigator's opinion, cannot be participated.

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Drug:
• HM781-36B
Q1DX14/2W for 3W HM781-36B

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited	Seoul National University

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 21 during Cycle 1