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A Study In Patients With Advanced Solid Tumor

Last updated on November 16, 2019

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

- Patients histologically or cytologically diagnosed with advanced solid tumors

- Patients for whom standard therapies have not been effective, or for whom there are no
suitable therapies

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2

- Patients with no uncontrolled hypertension

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

- Patients who have central lung lesions involving major blood vessels

- Patients who require anticoagulant therapy.

- Patients with active epilepsy seizure or symptoms, with brain metastases requiring
treatment, with spinal cord compression and with carcinomatous meningitis.

NCT00726752
Pfizer
Completed
A Study In Patients With Advanced Solid Tumor

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief Title  ICMJE A Study In Patients With Advanced Solid Tumor
Official Title  ICMJE A Phase 1 Study In Patients With Advanced Solid Tumor To Evaluate The Pharmacokinetics And Safety Of AG-013736 At Single Doses Of 5 mg, 7 mg And 10 mg, And At Multiple Doses
Brief SummaryThis study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses and multiple doses
Detailed DescriptionNot 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 Neoplasms
Intervention  ICMJE Drug: Axitinib (AG-013736)
Three single dose level of AG-013736 (5 mg, 7 mg and 10 mg) will be given for all patient. After single dosing at each dose level, multiple doses of 5 mg twice a day (BID) will be started.
Study Arms  ICMJE Experimental: Axitinib
Intervention: Drug: Axitinib (AG-013736)
Publications *Not Provided


*   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: July 30, 2008)
6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion DateApril 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients histologically or cytologically diagnosed with advanced solid tumors
  • Patients for whom standard therapies have not been effective, or for whom there are no suitable therapies
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
  • Patients with no uncontrolled hypertension

Exclusion Criteria:

  • Patients who have central lung lesions involving major blood vessels
  • Patients who require anticoagulant therapy.
  • Patients with active epilepsy seizure or symptoms, with brain metastases requiring treatment, with spinal cord compression and with carcinomatous meningitis.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00726752
Other Study ID Numbers  ICMJE A4061044
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2012

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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