A Phase 3 Study to Compare Efficacy and Safety of DHP107 Versus Taxol® in Patients With Metastatic or Recurrent Gastric Cancer After Failure of First-line Chemotherapy

Study Overview
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Brief Summary
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The objective of this study is to evaluate the efficacy and safety of DHP107 (Oral paclitaxel) in comparison to Taxol®(IV paclitaxel) in Patients With Metastatic or Recurrent Gastric Cancer After Failure of 1st Line Chemotherapy With Fluoropyrimidine +/- Platinum.

Official Title
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A Randomized, Open, Multicenter Phase 3 Study for Efficacy and Safety Assessment of DHP107 (Oral Paclitaxel) vs. Taxol® in Patients With Metastatic or Recurrent Gastric Cancer After Failure of First-line Chemotherapy With Fluoropyrimidine +/- Platinum

Conditions
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Stage IV Gastric Cancer

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥20 years of age Histologically or cytologically confirmed unresectable, recurrent or metastatic gastric cancer Failure of a first line therapy with fluoropyrimidine +/- platinum for metastatic or recurrent disease.(Adjuvant chemotherapy is not considered as a first line chemotherapy unless recurrence developed within 6 months of completion of adjuvant therapy.) Adequate bone marrow, liver and renal functions INR ≤ 2.0 ECOG performance status ≤ 2 Neuropathy grade ≤ 1 Life expectancy of at least 3 months Measurable lesion according to RECIST version 1.1 on CT scan Written informed consent Patients of child bearing age have to agree to the usage of adequate contraception from before the registration to the study, during the participation period and 90 days after the end of treatment. Female of child bearing age has to show negative for urin pregnancy test within 7 days from beginning of the start of administration. Amenorrhea status has to be sustained for at least 12 months to be considered non-pregnant in case of postmenstrual women. Exclusion Criteria: Major infectious disease, neurological disorder, or bowel obstruction. Patients with CNS metastases(confirmed through brain imaging if there are symptoms) Patient diagnosed with another cancer type (except non-melanoma skin cancer, cervical cancer, or any other cancer that did not recur or metastasized for more than 5 years and considered as complete remission can be registered) Patient who received radiation therapy within past 2 weeks or who had major surgery including organ resection within past 4 weeks from random assignment date Patient with the history of failure to the taxane chemotherapy Patient who need chronic concomitant use of P glycoprotein, immune suppressor, proton pump inhibitor, or H2-receptor antagonist during the period of clinical trial Chronic treatment using steroid (except oral, local injection, or for externally applied) or other immune suppressor Patient with myocardial infarction, congestive heart failure, arrhythmia showing abrupt change in the ECG, severe or unstable angina, or other serious heart disease Patient with other serious internal disease (chronic obstructive or chronic inhibitory lung disease including shortness of breathe at rest due to all reasons, uncontrollable diabetes and hypertension) History of abuse of a drug or alcohol within 3 months Lactating or pregnant women, or patient (or spouse) who has no intension of using, or cannot use very effective mean of contraception Patient who has or is suspected to have problem in bile acid secretion Patient with active gastrointestinal bleeding, or taking oral anti- vitamine K (With the exception of low dose of Warfarin and acetylsalicylic acide when INR≤2.0) History of serious hypersensitive reaction to the main ingredient or the excipient of the investigational drug History of being seropositive for HIV (HIV test is not a prerequisite). Patients with gastrointestinal dysfunction or on enteral feeding Other patients who are deemed inadequate to participate in the clinical trial by the investigator

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHP107 (oral paclitaxel)<br>DHP107 (oral paclitaxel) will be administered weekly as second line chemotherapy in patients with metastatic or recurrent gastric cancer after failure of first line chemotherapy with fluoropyrimidine +/- platinum. | Drug: Paclitaxel<br>* Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent<br>* Other names: DHP107;|
| Active Comparator: Taxol® (IV paclitaxel)<br>Taxol® (IV paclitaxel) will be administered 3-weekly as second line chemotherapy in patients with metastatic or recurrent gastric cancer after failure of first line chemotherapy with fluoropyrimidine +/- platinum. | Drug: Paclitaxel<br>* Premedication, IV infusion on day 1 of 3-week cycle until progression, unacceptable toxicity or withdrawal of informed concent<br>* Other names: Taxol®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | Progression Free Survival (PFS) is defined as the time From date of randomization until the date of first documented progression or death, assessed up to 24 months. | Participants will be followed until progression, an expected average of 4 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Overall survival (OS) is defined as the time from the date of inclusion to the date of death, regardless of the cause of death. | Until 6 months after the last participant is enrolled, assessed up to 24 months. | 
| Overall Response Rate (ORR) | Overall Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria. | Participants will be followed every 6 weeks until progression, an expected average of 4 months. | 
| Safety | Number and Description of Adverse Events | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasms, Gastric, Stomach Neoplasms, Cancer of Stomach, Gastric Cancer, Gastric Neoplasms, Neoplasms, Stomach, Stomach Cancer, paclitaxel, Taxol