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

Stage IV Gastric Cancer Clinical Trial

— DREAM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839773
• Other study ID #: 107CS-3
• Status: Completed
• Phase: Phase 3
• First received: April 12, 2013
• Last updated: August 9, 2015
• Start date: March 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Daehwa Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stage IV Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Paclitaxel
Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
• Paclitaxel
Premedication, IV infusion on day 1 of 3-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

Locations

Country	Name	City	State
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Kyungpook National University Medical Center	Daegu
Korea, Republic of	National Cancer Center	Goyang-si, Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si, Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Gangnam Severance Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Daehwa Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	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.	No
Secondary	Overall Survival (OS)	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.	No
Secondary	Overall Response Rate (ORR)	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.	No
Secondary	Safety	Number and Description of Adverse Events	Up to 24 months	Yes