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

NCT01455571 | Completed Phase 1

• 1 other identifier: HM-PHI-101
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• MTD determination

  Dose limiting Toxicity will be evaluated on Day 21 during Cycle 1

Study Arms (1)

HM781-36B

EXPERIMENTAL

Dose : 0.5mg, 1mg, 2mg, 4mg, 8mg, 12mg, 16mg, 20mg,...

Drug: HM781-36B

Interventions

HM781-36B DRUG

Q1DX14/2W for 3W HM781-36B

HM781-36B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• \) Patients with hematopoietic malignancies,uncontrolled infection, ileus, CNS metastasis.
• \) 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.
• \) Subjects who, in the investigator's opinion, cannot be participated.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead
• Seoul National University: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

HM781-36B

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: October 20, 2011
• Study Start: November 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 26, 2014

Record last verified: 2014-02

Locations

KR (1)