NCT01455584

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 23, 2013

Status Verified

April 1, 2013

Enrollment Period

1.9 years

First QC Date

October 18, 2011

Last Update Submit

May 22, 2013

Conditions

Advanced Solid Malignancies

Keywords

HM781-36B

Outcome Measures

Primary Outcomes (1)

  • MTD determination

    Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1

Study Arms (1)

HM781-36B

EXPERIMENTAL

HM781-36B

Drug: HM781-36B tablets

Interventions

HM781-36B tabletsDRUG

Q1X28D/4W for HM781-36B tablets

Also known as: HM781-36B
HM781-36B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed advanced solid tumor
  • Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy
  • 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
  • Aged ≥19
  • Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
  • A life expectancy greater than 12 weeks
  • Adequate bone marrow, renal and liver function.
  • 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, CNS metastasis.
  • Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT
  • Patients who have GI malabsorption or difficulty taking oral medication
  • Patients who have psychiatric or congenital disorder
  • Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments
  • Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

June 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 23, 2013

Record last verified: 2013-04

Locations

KR(1)