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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)

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ClinicalTrials.gov Identifier: NCT01839773
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Daehwa Pharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stage IV Gastric Cancer Drug: Paclitaxel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Paclitaxel

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 Name: DHP107

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
Premedication, IV infusion on day 1 of 3-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Other Name: Taxol®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Safety [ Time Frame: Up to 24 months ]
    Number and Description of Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839773


Locations
Korea, Republic of
Inje University Haeundae Paik Hospital
Busan, Korea, Republic of, 612-896
Kyungpook National University Medical Center
Daegu, Korea, Republic of, 702-210
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Chonnam National University Hwasun Hospital
Jeollanam-do, Korea, Republic of, 519-763
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of
Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120-752
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Yonsei University Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Ajou University Hospital
Suwon, Korea, Republic of, 443-380
Sponsors and Collaborators
Daehwa Pharmaceutical Co., Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daehwa Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01839773     History of Changes
Other Study ID Numbers: 107CS-3
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015

Keywords provided by Daehwa Pharmaceutical Co., Ltd.:
Stomach Neoplasms
Cancer of Stomach
Gastric Cancer
Gastric Neoplasms
Neoplasms, Gastric
Neoplasms, Stomach
Stomach Cancer
paclitaxel
Taxol

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action