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Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer

Last updated on December 12, 2019

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Study Location
Pfizer Investigational Site
Kashiwa, Chiba, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Stomach Neoplasms, Advanced Gastric Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- confirmed diagnosis of stomach cancer

- advanced stomach cancer of stage IV

- adequate blood chemistry, blood counts and kidney function

- willing to participate to study requirements and sign an informed consent document

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- prior chemotherapy for stomach cancer in its advanced stage

- excessive toxicities related to prior therapies

- pregnant or breastfeeding patients

NCT00842244
Pfizer
Completed
Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief Title  ICMJE Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer
Official Title  ICMJE A Phase 1 Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer
Brief Summary The purpose of this study is to determine the safe and tolerable dose of axitinib given together with cisplatin and capecitabine in patients with advanced gastric cancer who have not received prior chemotherapy for their advanced cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stomach Neoplasms
  • Advanced Gastric Cancer
Intervention  ICMJE
  • Drug: axitinib
    Twice daily oral dose of axitinib continuously depending upon side effects observed. Starting dose is 5mg twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
  • Drug: capecitabine
    Given orally twice daily for 14 days followed by 7 days of drug free period. Starting dose is 1000mg/m^2 twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
  • Drug: cisplatin
    Given through a vein on Day 1 of every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. The starting dose is 80 mg/m^2 on day 1.
Study Arms  ICMJE Experimental: A
Interventions:
  • Drug: axitinib
  • Drug: capecitabine
  • Drug: cisplatin
Publications * Oh DY, Doi T, Shirao K, Lee KW, Park SR, Chen Y, Yang L, Valota O, Bang YJ. Phase I Study of Axitinib in Combination with Cisplatin and Capecitabine in Patients with Previously Untreated Advanced Gastric Cancer. Cancer Res Treat. 2015 Oct;47(4):687-96. doi: 10.4143/crt.2014.225. Epub 2015 Feb 12.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2012)
22
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2009)
30
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • confirmed diagnosis of stomach cancer
  • advanced stomach cancer of stage IV
  • adequate blood chemistry, blood counts and kidney function
  • willing to participate to study requirements and sign an informed consent document

Exclusion Criteria:

  • prior chemotherapy for stomach cancer in its advanced stage
  • excessive toxicities related to prior therapies
  • pregnant or breastfeeding patients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00842244
Other Study ID Numbers  ICMJE A4061055
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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