DREAM: 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

Sponsor

Daehwa Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01839773

Collaborator

(none)

238

Enrollment

Locations

Arms

Duration (Months)

19.8

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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 Drug: Paclitaxel	Phase 3

Study Design

Study Type:

Interventional

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 :

Mar 1, 2013

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

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
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 Names: Taxol®

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

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 Names:

Taxol®

Outcome Measures

Primary Outcome Measures

Progression Free Survival (PFS) [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

Overall Survival (OS) [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.
Overall Response Rate (ORR) [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.
Safety [Up to 24 months]
Number and Description of Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Inje University Haeundae Paik Hospital	Busan	Korea, Republic of	612-896
2	Kyungpook National University Medical Center	Daegu	Korea, Republic of	702-210
3	National Cancer Center	Goyang-si, Gyeonggi-do	Korea, Republic of	410-769
4	Chonnam National University Hwasun Hospital	Jeollanam-do	Korea, Republic of	519-763
5	Seoul National University Bundang Hospital	Seongnam-si, Gyeonggi-do	Korea, Republic of
6	Yonsei University Severance Hospital	Seoul	Korea, Republic of	120-752
7	Samsung Medical Center	Seoul	Korea, Republic of	135-710
8	Yonsei University Gangnam Severance Hospital	Seoul	Korea, Republic of	135-720
9	Seoul St. Mary's Hospital	Seoul	Korea, Republic of	137-701
10	Asan Medical Center	Seoul	Korea, Republic of	138-736
11	Korea University Guro Hospital	Seoul	Korea, Republic of	152-703
12	Ajou University Hospital	Suwon	Korea, Republic of	443-380