Neoplasms

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Breast Neoplasms

Recurrence

Breast Diseases

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Disease Attributes

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

Gastrointestinal Stromal Tumors

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Anti-Infective Agents

Sunitinib

Imatinib Mesylate

polysaccharide-K

Liporaxel 200mg/m2 twice daily orally on day 1, 8, and 15 every 4 weeks (1 cycle = 4 weeks)

Liporaxel

Min-Hee Ryu, MD, PhD

Hyung-Don Kim, MD, PhD

The purpose of this study is to evaluate safety and efficacy of Liporaxel for patients with GIST who failed on prior standard treatments, including imatinib, sunitinib, and regorafenib, and with low P-glycoprotein expression.

The survival outcomes of patients with advanced and/or metastatic gastrointestinal stromal tumors (GIST) have markedly improved with application of imatinib, the KIT tyrosine kinase inhibitor (GlivecTM, Novartis) for the treatment. Recently, sunitinib (SuteneTM, Pfizer) and regorafenib (StivargaTM, Bayer) have shown efficacy in patients with disease progression on imatinib as second- and third-line treatment, respectively. However, most patients develop acquired resistance to KIT tyrosine kinase inhibitors and show disease progression.

While cytotoxic chemotherapeutic agents were expected to have minimal antitumor effect on GIST, recent preclinical studies have shown that 37 out of 89 different chemotherapeutic agents have shown antitumor effects on at least one or more GIST cell lines. Especially, topoisomerase II inhibitors, paclitaxel, bortezomib have shown promising results. Based on the results, the investigators conducted a single center, single arm phase II study to evaluate efficacy and safety of paclitaxel for patients with GIST who failed to prior imatinib and sunitinib. Overall efficacy was modest, although patients with low P-glycoprotein expression showed better efficacy compared to those with high P-glycoprotein expression. Subsequently, the investigators performed another phase 2 trial to evaluate efficacy of paclitaxel for previously treated GIST patients with low P-glycoprotein expression and have met the primary endpoint.

Liporaxel is an oral formulation of paclitaxel, and showed high bioavailability, safety, and antitumor effect from non-clinical studies. From a phase 1 clinical trial for metastatic solid tumor patients, Liporaxel showed adequate PK/PD profiles. Compared to intravenous paclitaxel, administration is relatively easier and has better safety in terms of hypersensitivity reaction which is caused by the admixture of intravenous formulation of paclitaxel. From a multicenter phase 3 trial conducted in South Korea for patients with advanced gastric adenocarcinoma who failed on first-line palliative chemotherapy (DREAM trial), Liporaxel showed non-inferiority compared to intravenous paclitaxel in terms of both safety and efficacy, and it is currently approved for the second-line treatment in advanced gastric cancer. Also, Liporaxel proved safety and potential efficacy in patients with HER2 negative metastatic breast cancer as first-line chemotherapy, and currently multicenter phase 3 trial in ongoing (OPTIMAL3 trial).

The purpose of this study is to evaluate safety and efficacy of Liporaxel for patients with GIST who failed on prior standard treatments, including imatinib, sunitinib, and regorafenib, and with low P-glycoprotein expression.

GIST Oral Paclitaxel(Liporaxel)

A Phase II Study of Oral Paclitaxel (Liporaxel) in GIST Patients With a Low P-glycoprotein Expression After Failure With Imatinib, Sunitinib and Regorafenib

according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

time from the date of first administration of palliative first-line chemotherapy to the date of the first objectively documented tumor progression or death, whichever occurs first)

time from the date of first administration of palliative first-line chemotherapy to the date of death due to any cause

Asan Medical Center

Professor

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.
GIST Oral Paclitaxel(Liporaxel)	NCT06326346	Gastrointestina...	Liporaxel	20 Years -	Asan Medical Center
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 liporaxel

Every month we try and update this database with for liporaxel 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 liporaxel

Every month we try and update this database with for liporaxel 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 liporaxel 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.