Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Topoisomerase I Inhibitors

Enzyme Inhibitors

HM30181AK 60 mg tablet + Irinotecan 20mg, 5 mg or 2mg tablets

HM30181AK tablet + Irinotecan tablets

Tae-Yoo Kim, M.D. Ph.D

The main objective of this study is to determine the maximum tolerated dose (MTD) of OratecanTM. Eligible subjects of this study are patients with histologically or cytologically confirmed malignant solid tumor refractory to standard therapy.

The irinotecan hydrochloric acid (HCl) tablet is escalated and administered per body surface area (BSA). The dose of HM30181A 60 mg is fixed.

The Route of administration of irinitecan and HM30181A is oral. Each cycle consists of 21 days. Drugs are administered daily for 10 consecutive days (D1, 2, 3, 4, 5, 8, 9, 10, 11 and 12) followed by a washout of 9 days.

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

1. To determine dose-limiting toxicity (DLT) of OratecanTM
2. To characterize the pharmacokinetics of HM30181A, irinotecan and its metabolites (SN-38 and SN-38G) following oral administration of OratecanTM
3. To evaluate anticancer activity of OratecanTM in patients with advanced solid malignancies Groups of 3 patients per cohort or dose level will be treated with escalating doses of irinotecan in combination with a fixed 60mg dose of HM30181A.

If 0/3 patients at any dose level experience a DLT, the dose of irinotecan will be escalated by 10 mg/m2 in the next dose level. If 1/3 patients at any dose level experience a DLT, the cohort will be expanded by 3 additional patients to 6 patients. If no additional patients develop DLT, the dose of irinotecan will again be escalated in the next cohort of 3 patients. If 2/3 or 2/6 patients develop DLT, then dose escalation will cease, and the previous dose will be declared the MTD.

Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Patients With Advanced Solid Malignancies (Oratecan-102)

A Phase I Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety and Pharmacokinetic Profile of OratecanTM in Patients With Advanced Solid Cancer((Q1DX5/W)X2 for 3W)

Hanmi Pharmaceutical Company Limited

Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Recurrence

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules

Kyung-Mi Park, Ph.D

Sook Ryun Park, M.D, Ph.D

Yung-Jue Bang, M.D, Ph.D

Yung-Jue Bang, MD. Ph.D

The main objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II.

Administration Schedule: 1 cycle of Oraxol® is 28 days and Oraxol® is administrated twice a week, total 6 times per cycle (day 1,2,8,9,15 and 16).

A Study of Oraxol® in Gastric Cancer Patients

A Phase I-II Clinical Trial to Determine Recommended Dose and to Assess the Efficacy, Safety and Pharmacokinetic Profile of Oral Paclitaxel(Oraxol®) in Patients With Advanced/Metastatic or Recurrent Gastric Cancer

Toxicity will be evaluated by medical history, vital signs, physical examination and laboratory tests performed during the screening period (D-28 to D0) and treatment period based on NCI-CTCAE (version 3.0).

It is measured up to confirmation of tumor response(CR, PR)

Tumor response will be evaluated by RECIST v1.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Patients With Advanced Solid Malignancies (Oratecan-102)	NCT00986843	Advanced Solid ...	HM30181AK table...	19 Years -	Hanmi Pharmaceutical Company Limited
A Study of Oraxol® in Gastric Cancer Patients	NCT01491217	Advanced Metast... Recurrent Gastr...	Paclitaxel	19 Years -	Hanmi Pharmaceutical Company Limited
Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Patients With Advanced Solid Malignancies (Oratecan-102)	NCT00986843	Advanced Solid ...	HM30181AK table...	19 Years -	Hanmi Pharmaceutical Company Limited

Spots Global Cancer Trial Database for hm30181a

Every month we try and update this database with for hm30181a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hm30181a

Every month we try and update this database with for hm30181a cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hm30181a cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.