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

This study has been completed.
Sponsor:
Collaborator:
Seoul National University
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01455571
First received: October 18, 2011
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Advanced Solid Tumor
Drug: HM781-36B
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of HM781-36B

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • MTD determination [ Time Frame: Dose limiting Toxicity will be evaluated on Day 21 during Cycle 1 ] [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: November 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HM781-36B
Dose : 0.5mg, 1mg, 2mg, 4mg, 8mg, 12mg, 16mg, 20mg,...
Drug: HM781-36B
Q1DX14/2W for 3W HM781-36B

Detailed 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
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455571

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Seoul National University
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01455571     History of Changes
Other Study ID Numbers: HM-PHI-101
Study First Received: October 18, 2011
Last Updated: February 24, 2014
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on August 19, 2014