Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01839773
Other study ID # 107CS-3
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT02291211 - S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis Phase 2
Terminated NCT01705340 - Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery Phase 1
Completed NCT01178944 - Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer Phase 2
Completed NCT00982592 - Combination Chemotherapy With or Without Vismodegib in Treating Patients With Advanced Stomach Cancer or Gastroesophageal Junction Cancer Phase 2
Completed NCT00991952 - Irinotecan Hydrochloride With or Without Alvocidib in Treating Patients With Advanced Stomach or Gastroesophageal Junction Cancer That Cannot Be Removed By Surgery Phase 2
Completed NCT01846520 - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers N/A
Completed NCT01191684 - Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer Phase 1
Terminated NCT01233505 - Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT00006389 - Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer Phase 2
Terminated NCT01249443 - Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection Phase 1
Completed NCT01612546 - Pilot Trial of CRLX101 in Treatment of Patients With Advanced or Metastatic Stomach, Gastroesophageal, or Esophageal Cancer That Cannot be Removed by Surgery Phase 2
Completed NCT00028496 - Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer Phase 1
Active, not recruiting NCT01939275 - 64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer N/A
Active, not recruiting NCT01637805 - Clinical Safety and Preliminary Efficacy of AAV-DC-CTL Treatment in Stage IV Gastric Cancer Phase 1
Terminated NCT00087191 - EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer N/A
Withdrawn NCT02344810 - C-Met Inhibitor AMG 337, Oxaliplatin, Leucovorin Calcium, and Fluorouracil in Treating Patients With Advanced Stomach or Esophageal Cancer Phase 1/Phase 2
Completed NCT01643499 - Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies Phase 1
Completed NCT00084617 - Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma Phase 2
Completed NCT00068380 - A Phase II Trial of STI571 in the Treatment of Metastatic Gastric Cancer Phase 2
Terminated NCT00064259 - A Phase I/II Study of Oblimersen Plus Cisplatin and Fluorouracil in Gastric & Esophageal Junction Cancer Phase 1/Phase 2