AzTrials
AzTrials

Stage IV Gastric CancerPhase 3DREAMNCT01839773

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

A Phase 3 study testing Paclitaxel in people with Stage IV Gastric Cancer, run by Daehwa Pharmaceutical Co., Ltd. at 13 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Stage IV Gastric Cancer
What is being tested?
Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
13 sitesSouth Korea
Study dates
Mar 2013to Aug 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

South Korea13 sites

  • Inje University Haeundae Paik Hospital

    Busan, 612-896

  • Kyungpook National University Medical Center

    Daegu, 702-210

  • National Cancer Center

    Goyang-si, 410-769

  • Chonnam National University Hwasun Hospital

    Jungnam, 519-763

  • Seoul National University Bundang Hospital

    Seongnam-si

  • Yonsei University Severance Hospital

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Yonsei University Gangnam Severance Hospital

    Seoul, 135-720

  • Seoul St. Mary's Hospital

    Seoul, 137-701

  • Asan Medical Center, University of Ulsan College of Medicine

    Seoul, 138-736

  • Asan Medical Center

    Seoul, 138-736

  • Korea University Guro Hospital

    Seoul, 152-703

  • Ajou University Hospital

    Suwon, 443-380

Other trials in South Korea

About this study

Official title: 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.

Being tested
Paclitaxel
Keywords
Stomach Neoplasms, Cancer of Stomach, Gastric Cancer, Gastric Neoplasms, Neoplasms, Gastric, Neoplasms, Stomach, Stomach Cancer, paclitaxel, Taxol
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called DHP107

    Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

  • PaclitaxelDrug

    Also called Taxol®

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

Study groups in NCT01839773
Study groupRoleWhat they receive
DHP107 (oral paclitaxel)ExperimentalDHP107 (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.
Receives: Drug: Paclitaxel
Taxol® (IV paclitaxel)Active comparatorTaxol® (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.
Receives: Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Participants will be followed until progression, an expected average of 4 months.

Secondary outcomes (2)

  1. Overall Survival

    OS is defined as the time from the date of inclusion to the date of death, regardless of the cause of death.

    Measured: Until 6 months after the last participant is enrolled, assessed up to 24 months.

  2. Overall Response Rate

    ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.

    Measured: Participants will be followed every 6 weeks until progression, an expected average of 4 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
238 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01839773
Sponsor's protocol ID
107CS-3
Acronym
DREAM
Status last verified
Jul 2024
First submitted
12 Apr 2013
Last updated
25 Jul 2024
Results posted
No
Data monitoring committee
No

Publications

  • Kang YK, Ryu MH, Park SH, Kim JG, Kim JW, Cho SH, Park YI, Park SR, Rha SY, Kang MJ, Cho JY, Kang SY, Roh SY, Ryoo BY, Nam BH, Jo YW, Yoon KE, Oh SC. Efficacy and safety findings from DREAM: a phase III study of DHP107 (oral paclitaxel) versus i.v. paclitaxel in patients with advanced gastric cancer after failure of first-line chemotherapy. Ann Oncol. 2018 May 1;29(5):1220-1226. doi: 10.1093/annonc/mdy055.

    PubMed 29438463

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paclitaxel in people with Stage IV Gastric Cancer, run by Daehwa Pharmaceutical Co., Ltd. at 13 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Participants will be followed until progression, an expected average of 4 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01839773, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in