Phase 3 Study to Compare Efficacy and Safety of DHP107 vs. Taxol® in Patients With Metastatic or Recurrent Gastric Cancer (DREAM)

July 23, 2024 updated by: Daehwa Pharmaceutical Co., Ltd.

A Randomized, Open-label, 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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
238

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 612-896
        • Inje University Haeundae Paik Hospital
      • Chungnam, Korea, Republic of, 519-763
        • Chonnam National University Hwasun Hospital
      • Daegu, Korea, Republic of, 702-210
        • Kyungpook National University Medical Center
      • Goyang-si, Korea, Republic of, 410-769
        • National Cancer Center
      • Seongnam-si, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 137-701
        • Seoul St. Mary'S Hospital
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center, University of Ulsan College of Medicine
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University Severance Hospital
      • Seoul, Korea, Republic of, 135-720
        • Yonsei University Gangnam Severance Hospital
      • Suwon, Korea, Republic of, 443-380
        • Ajou University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥20 years of age
  2. Histologically or cytologically confirmed unresectable, recurrent or metastatic gastric cancer
  3. 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.)
  4. Adequate bone marrow, liver and renal functions
  5. INR ≤ 2.0
  6. ECOG performance status ≤ 2
  7. Neuropathy grade ≤ 1
  8. Life expectancy of at least 3 months
  9. Measurable lesion according to RECIST version 1.1 on CT scan
  10. Written informed consent
  11. 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:

  1. Major infectious disease, neurological disorder, or bowel obstruction.
  2. Patients with CNS metastases(confirmed through brain imaging if there are symptoms)
  3. 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)
  4. 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
  5. Patient with the history of failure to the taxane chemotherapy
  6. Patient who need chronic concomitant use of P glycoprotein, immune suppressor, proton pump inhibitor, or H2-receptor antagonist during the period of clinical trial
  7. Chronic treatment using steroid (except oral, local injection, or for externally applied) or other immune suppressor
  8. Patient with myocardial infarction, congestive heart failure, arrhythmia showing abrupt change in the ECG, severe or unstable angina, or other serious heart disease
  9. 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)
  10. History of abuse of a drug or alcohol within 3 months
  11. Lactating or pregnant women, or patient (or spouse) who has no intension of using, or cannot use very effective mean of contraception
  12. Patient who has or is suspected to have problem in bile acid secretion
  13. 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)
  14. History of serious hypersensitive reaction to the main ingredient or the excipient of the investigational drug
  15. History of being seropositive for HIV (HIV test is not a prerequisite).
  16. Patients with gastrointestinal dysfunction or on enteral feeding
  17. Other patients who are deemed inadequate to participate in the clinical trial by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DHP107 (oral paclitaxel)
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
Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Other Names:
  • DHP107
Drug: Paclitaxel
Premedication, IV infusion on day 1 of 3-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Other Names:
  • Taxol®
Active Comparator: Taxol® (IV paclitaxel)
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
Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Other Names:
  • DHP107
Drug: Paclitaxel
Premedication, IV infusion on day 1 of 3-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Other Names:
  • Taxol®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Participants will be followed until progression, an expected average of 4 months.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Until 6 months after the last participant is enrolled, assessed up to 24 months.
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
Time Frame: Participants will be followed every 6 weeks until progression, an expected average of 4 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daehwa Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 107CS-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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