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

NCT01839773 | Completed Phase 3

• 1 other identifier: 107CS-3
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 13

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.

Conditions

Stage IV Gastric Cancer

Keywords

Stomach Neoplasms; Cancer of Stomach; Gastric Cancer; Gastric Neoplasms; Neoplasms, Gastric; Neoplasms, Stomach; Stomach Cancer; paclitaxel; Taxol

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

• Overall Survival

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

• Overall Response Rate

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

Study Arms (2)

DHP107 (oral paclitaxel)

EXPERIMENTAL

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

Taxol® (IV paclitaxel)

ACTIVE COMPARATOR

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

Interventions

Paclitaxel DRUG

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

Also known as: DHP107

DHP107 (oral paclitaxel)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Daehwa Pharmaceutical Co., Ltd.: lead

Study Sites (13)

Inje University Haeundae Paik Hospital

Busan, 612-896, South Korea

Location

Kyungpook National University Medical Center

Daegu, 702-210, South Korea

Location

National Cancer Center

Goyang-si, 410-769, South Korea

Location

Chonnam National University Hwasun Hospital

Jungnam, 519-763, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Yonsei University Severance Hospital

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Yonsei University Gangnam Severance Hospital

Seoul, 135-720, South Korea

Location

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Ajou University Hospital

Suwon, 443-380, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29438463 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 25, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

KR (13)