Clinical Trial Details

NCT ID: NCT03042611
Date Last Changed: September 27, 2017

Overview

Research Study Summary

A clinical trial to evaluate treatments using Apatinib and Placebo for patients with Gastric Cancer or Gastric Adenocarcinoma

Research Study Title

A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Multinational, Multicenter, Parallel-group, Phase III Study to Evaluate the Efficacy and Safety of Apatinib Plus Best Supportive Care (BSC) Compared to Placebo Plus BSC in Patients With Advanced or Metastatic Gastric Cancer

Purpose

The purpose of this study is to evaluate the clinical benefit and safety of Apatinib plus Best Supportive Care in comparison to Placebo plus Best Supportive Care in patients with advanced or metastatic gastric cancer

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
LSK BioPartners Inc.
Duration
18 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  1. Male or female ≥ 18 years of age.

  2. Documented primary diagnosis of histologic- or cytologic-confirmed adenocarcinoma of the stomach or gastroesophageal junction.

  3. Locally advanced unresectable or metastatic disease that has progressed since last treatment.

  4. One or more measurable or nonmeasurable evaluable lesions per RECIST 1.1.

  5. Failure or intolerance to at least two prior lines of standard chemotherapies with each containing one or more of the following agents:

  6. fluoropyrimidine (IV 5-FU capecitabine, or S-1),

  7. platinum (cisplatin or oxaliplatin),

  8. taxanes (paclitaxel or docetaxel) or epirubicin,

  9. irinotecan,

  10. trastuzumab in case of HER2-positive

  11. ramucirumab

  12. Disease progression within 6 months after the last treatment.

  13. Adequate bone-marrow, renal and liver function.

  14. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

  15. Expected survival of ≥ 12 weeks, in the opinion of the investigator.

  16. Ability to swallow the investigational product tablets.

  17. Female patients with negative pregnancy test at Screening and use of acceptable method of birth control for study duration, unless surgically sterile or postmenopausal for at least 1 year prior to Screening.

  18. Ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures.

Exclusion Criteria:

  1. Malignancies other than adenocarcinoma of the stomach or gastroesophageal junction (including hematologic malignancies) within 3 years.

  2. CNS metastases as shown by radiology records or clinical evidence of symptomatic CNS involvement in the last 3 months prior to randomization.

  3. Cytotoxic chemotherapy, surgery, immunotherapy, radiotherapy or other targeted therapies within 4 weeks (6 weeks in cases of ramucirumab, mitomycin C, nitrosourea, lomustine; 2 weeks in case of biopsy) prior to randomization (Adjuvant radiotherapy given to local area for non-curative symptom relief is allowed until 2 weeks before randomization.).

  4. Therapy with clinically significant systemic anticoagulant or antithrombotic agents within 7 days prior to randomization that may prevent blood clotting and, in the investigator's opinion, could place the subject at risk.

  5. Patients who had therapeutic paracentesis of ascites ( > 1L) within the 3 months prior to starting study treatment or who, in the opinion of the investigator, will likely need therapeutic paracentesis of ascites ( > 1L) within 3 months of starting study treatment.

  6. Previous treatment with Apatinib.

  7. Known hypersensitivity to Apatinib or components of the formulation.

  8. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19.

  9. Active bacterial infections.

  10. Substance abuse or medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.

  11. Participation in any other clinical trial within 4 weeks prior to randomization.

  12. Pregnant or breast-feeding women.

  13. History of drug or alcohol abuse within past 5 years.

  14. Medical or psychiatric illnesses that, in the investigator's opinion, may impact the safety of the subject or the objectives of the study.

  15. History of uncontrolled hypertension (Blood pressure ≥ _140/90 mmHg and change in antihypertensive medication within 7 days prior to randomization) that is not well managed by medication and the risk of which may be precipitated by a VEGF inhibitor therapy.

  16. Known history of symptomatic congestive heart failure (New York Heart Association III-IV), symptomatic or poorly controlled cardiac arrhythmia, complete left bundle branch block, bifascicular block, or any clinically significant ST segment and/or T-wave abnormalities, QTcF > 450 msec prior to randomization.

  17. Prior major surgery or fracture within 3 weeks prior to randomization or presence of any non-healing wound.

  18. History of bleeding diathesis or clinically significant bleeding within 14 days prior to randomization.

  19. History of clinically significant thrombosis within the past 3 months prior to randomization that, in the investigator's opinion, may place the patient at risk of side effects from anti-angiogenesis products.

  20. History of gastrointestinal bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3 months prior to randomization that, in the investigator's opinion, may place the patient at risk of side effects from anti-angiogenesis products.

  21. Myocardial infarction or unstable angina pectoris within 6 months prior to randomization.

  22. History of severe adverse events, in the investigator's opinion, related to ramucirumab.

  23. History of other significant cardiovascular diseases or vascular diseases within the last 6 months prior to randomization that, in the investigator's opinion, may pose a risk to the patient on VEGF inhibitor therapy.

  24. History of clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies.

  25. Gastrointestinal malabsorption, or any other condition that in the opinion of the investigator might affect the absorption of the study drug.

Site Locations (48)

Country State City Zip Facility and Contact
United States Arkansas Fayetteville 72703 Highlands Oncology Group
United States Michigan Detroit 48201 Karmanos Cancer Institute
United States Minnesota Rochester 55905 Mayo Clinic Cancer Center
Japan Akasi-city Hyogo 673-0021 Hyogo Cancer Center
Japan Chiba City Chiba 260-8717 Chiba Cancer Center
Japan Chuo-ku Tokyo 104-0045 National Cancer Center Hospital
Japan Higashi-ku Fukuoka 812-8582 Kyushu University Hospital
Japan Kashiwa Chiba 277-8577 National Cancer Center Hospital East
Japan Kawasaki-shi Kanagawa 216-8511 St. Marianna University Hospital
Japan Kitaadachi-gun Saitama 362-0806 Saitama Cancer Center
Japan Kitakyushu-shi Fukuoka 806-8501 Japan Community Health Care Organization Kyushu Hospital
Japan Koto-ku Tokyo 135-8550 The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Japan Matsuyama Ehime 791-0280 Shikoku Cancer Center
Japan Saku-shi Nagano 385-0051 Saku Central Hospital Advanced Care Center
Japan Sapporo Hokkaido 060-8648 Hokkaido University Hospital
Japan Shinjuku-ku Tokyo 160-8582 Keio University Hospital
Japan Suita Osaka 565-0871 Osaka University Hospital
Japan Nagoya 464-8681 Aichi Cancer Center Hospital
Korea, Republic of Busan Haeundae-gu 48108 Inje University Haeundae Paik Hospital
Korea, Republic of Busan Seo-gu 49201 Dong-A University Hospital
Korea, Republic of Busan Seo-gu 49241 Pusan National University Hospital
Korea, Republic of Chungcheongbuk-do Seowon-gu 41404 Chungbuk National University Medical Center
Korea, Republic of Daegu Buk-gu 41404 Kyungpook National University Medical Center
Korea, Republic of Daegu Jung-gu 41931 Keimyung University Dongsan Medical Center
Korea, Republic of Daegu Nam-gu 42415 Yeungnam University Medical Center
Korea, Republic of Daejeon Jung-gu 35015 Chungnam National University Hospital
Korea, Republic of Gyeonggi-do Anyang-si 14069 Hallym University Sacred Heart Hospital
Korea, Republic of Gyeonggi-do Bundang-gu 13620 Seoul National University Bundang Hospital
Korea, Republic of Gyeonggi-do Goyang-si 10408 National Cancer Center
Korea, Republic of Gyonggi-do Suwon-si 16499 Ajou University Hospital
Korea, Republic of Incheon Namdong-gu 21555 Gachon University Gil Medical Center
Korea, Republic of Jeollabuk-do Jeonju-si 54907 Chonbuk National University Hospital
Korea, Republic of Seoul Gangdong-gu 05368 Veterans Health Service (VHS) Medical Center
Korea, Republic of Seoul Gangnam-gu 06273 Gangnam Severance Hospital
Korea, Republic of Seoul Gangnam-gu 06351 Samsung Medical Center
Korea, Republic of Seoul Guro-gu 08308 Korea University Guro Hospital
Korea, Republic of Seoul Seodaemun-gu 03722 Severence Hospital, Yonsei University Health System
Korea, Republic of Seoul Seongbuk-gu 02841 Korea University Anam Hospital
Korea, Republic of Seoul Songpagu 05505 ASAN Medical Center
Korea, Republic of Ulsan Dong-gu 44033 Ulsan University Hospital
Taiwan Beitou Dist Taipei 11217 Taipei Veterans General Hospital
Taiwan Kuei Shan Hsiang Taoyuan 333 Chang Gung Memorial Hospital - Linko Branch
Taiwan Liuying DIst Tainan 736 Chi Mei Medical Center - LiouYing Branch
Taiwan Niaosong Dist Kaohsiung 83301 Chang Gung Memorial Hospital - Kaohsiung Branch
Taiwan Sanmin Dist Kaohsiung 80708 Kaohsiung Medical University Hospital
Taiwan Taichung City Taichung 40447 China Medical University Hospital
Taiwan Tainan City Tainan 70403 National CHeng Kung University Hospital
Taiwan Zhongzheng Dist Taipei 100 National Taiwan University Hospital

Contact

Rahul Gowda (South Korea)
+82-2-546-1008
E-mail:

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