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Breast Neoplasms

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Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

* 28 days (4 weeks) will be set as one cycle of administration and Liporaxel® will be administered for 3 weeks, twice a day, every morning and evening (D1, D8, D15) and will take a week off on 4th week.
* Liproaxel® 200mg/m2 will be orally administered twice a day (morning, evening) 1 hour after meal for D1, D8, D15 of every cycle. 10 hour-interval is recommended for between each administration.

* 28 days (4 weeks) will be set as one cycle and for every 3 week administration, 1 week off dose period will be given.
* Taxol® 80mg/m2 will be administered via IV and it must be diluted before drip administration. Dilute with 0.9% sodium chloride injection solution to make final concentration of 0.3-1.2 mg/mL.

Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

Oral paclitaxel

Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

Paclitaxel injection

Sung-bae Kim, M.D., Ph.D

To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.

1. Phase II clinical trial

   * Multicenter, Open-label, Single arm, Simon's optimal two-stage design
2. Phase III clinical trial

   * Multicenter, Prospective Randomized Open-label Blinded Endpoint (PROBE) design

Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy

A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Liporaxel® (Oral Paclitaxel) Compared to Taxol® (IV Paclitaxel) as First-line Therapy in Patients With Recurrent or Metastatic HER2 Negative Breast Cancer

Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.

Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death

Overall survival(OS) is defined as the time from the date of inclusion to the date of death, regardless of the cause of death.

TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.

DCR is defined as the percentage of subjects who were evaluated for complete response(CR), partial response(PR), and stable disease(SD) as the best response among from randomization to End of treatment(EOT).

To evaluate changes versus baseline using the EQ-5D.

Daehwa Pharmaceutical Co., Ltd.

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

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.

Hanmi Pharmaceutical Company Limited

DHP107 200 mg/m2 orally twice daily on Days 1, 8, and 15 in every 28 days (On food effect study day, DHP107 200 mg/m2 orally once daily on Days 1, 8 of Cycle 1 with fasted or fed condition according to the assigned sequence)

DHP107(Oral paclitaxel)

Erika Hitre, M.D., Ph.D

István TAKÁCS

Dénes PÁLL

To evaluate the food effect on pharmacokinetics of DHP107 in patients with advanced solid tumors.

This is a randomized, open-label, two-way crossover study consisting of two sequences (RT, TR) in patients with advanced solid tumor.

Food Effect on Pharmacokinetics and SafEty of DHP107 (Liporaxel®) FEEL Study

A Randomized, Open-label, Two-way Crossover Clinical Trial to Evaluate the Food Effect on Pharmacokinetics and Safety of DHP107 (Oral Paclitaxel, Liporaxel®) in Patients With Advanced Solid Tumors (FEEL) / EudraCT no : 2020-004976-16

The primary endpoints of this trial are the ratio of geometric means of the following pharmacokinetic parameters following DHP107 administration fed with fasting condition

and the median difference of the following pharmacokinetic parameters following DHP107 administration fed with fasting condition:

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy	NCT03315364	Recurrent or Me...	Oral paclitaxel Paclitaxel inje...	19 Years -	Daehwa Pharmaceutical Co., Ltd.
A Study of Oraxol® in Gastric Cancer Patients	NCT01491217	Advanced Metast... Recurrent Gastr...	Paclitaxel	19 Years -	Hanmi Pharmaceutical Company Limited
Food Effect on Pharmacokinetics and SafEty of DHP107 (Liporaxel®) FEEL Study	NCT04675528	Advanced Solid ...	DHP107(Oral pac...	18 Years -	Daehwa Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for oral paclitaxel