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

COMPLETEDPHASE1

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

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

NCT01455584•Hanmi Pharmaceutical Company Limited

View on ClinicalTrials.gov

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

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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.)

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

June 1, 2011

Primary Completion Date

May 1, 2013

Completion Date

May 1, 2013

Last Updated

May 23, 2013

Enrollment

ACTUAL participants

Conditions

Advanced Solid Malignancies

Interventions

HM781-36B tablets

DRUG

Phase I/Ib Trial of TIraGolumab, AtEzolizumab, and RadScopal Radiation in Patients With Advanced Solid Malignancies (TIGER)

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Advanced Solid Malignancies

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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies

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Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Phase I/Ib Trial of TIraGolumab, AtEzolizumab, and RadScopal Radiation in Patients With Advanced Solid Malignancies (TIGER)

Safety and Efficacy Study of CFI-402411 in Subjects With Advanced Solid Malignancies

Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies

Effects of LBM and PPIs on Pharmacokinetics and Safety of Regorafenib (BAY 73-4506) in Cancer Patients

A Study of HSP990 Administered by Mouth in Adult Patients With Advanced Solid Tumors

Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies