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 (DREAM)

August 9, 2015 updated by: Daehwa Pharmaceutical Co., Ltd.

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

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • 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
      • Daegu, Korea, Republic of, 702-210
        • Kyungpook National University Medical Center
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center
      • Jeollanam-do, Korea, Republic of, 519-763
        • Chonnam National University Hwasun Hospital
      • Seongnam-si, Gyeonggi-do, 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, 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

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
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

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Participants will be followed until progression, an expected average of 4 months.
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)
Time Frame: Until 6 months after the last participant is enrolled, assessed up to 24 months.
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)
Time Frame: Participants will be followed every 6 weeks until progression, an expected average of 4 months.
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
Time Frame: Up to 24 months
Number and Description of Adverse Events
Up to 24 months

Collaborators and Investigators

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

Sponsor

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

March 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 12, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 9, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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