Asian Phase I Study Of PF-03446962

Back to Search
Print
Bookmark Trial

NCT01337050

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

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]

Call Now

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
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/metastasis solid tumor refractory or intolerant to established therapy

- adequate blood chemistry, blood counts and kidney/liver 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


- Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of
first dose of study medication


- excessive toxicities related to prior therapies


- pregnant or breastfeeding patients

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

NeoplasmsSTUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS
NCT04635631
  1. Changchun, Jilin
  2. Beijing,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
NeoplasmsBRAF V600E-mutant Colorectal Cancer Study of Encorafenib Taken With Cetuximab Plus or Minus Chemotherapy (BREAKWATER)
NCT04607421
  1. Duarte, California
  2. Creve Coeur, Missouri
  3. Florissant, Missouri
  4. Saint Louis, Missouri
  5. Saint Louis, Missouri
  6. Saint Louis, Missouri
  7. Saint Louis, Missouri
  8. Saint Peters, Missouri
  9. Germantown, Tennessee
  10. Memphis, Tennessee
  11. Houston, Texas
  12. Houston, Texas
  13. Woodville, South Australia
  14. Clayton, Victoria
  15. Melbourne, Victoria
ALL GENDERS
16 Years+
years
MULTIPLE SITES
NeoplasmsPharmacodynamic Study of Axitinib in Patients With Advanced Solid Malignancies
NCT00859118
  1. Madison, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
NeoplasmsSafety Study of an Immune Response Modifier in Patients With Refractory Solid Organ Tumors
NCT00095160
  1. Minneapolis, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Asian Phase I Study Of PF-03446962
Official Title  ICMJE A Phase I Pharmacokinetic And Pharmacodynamic Study Of Pf-03446962 In Asian Patient With Advanced Solid Tumors
Brief Summary This is an Asian Phase 1, multi center, open label, single arm study of PF 03446962 with dose escalation and designed to define the Maximum Tolerated Dose [MTD] and the Recommended Phase 2 Dose [RP2D].
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: Basic Science
Condition  ICMJE Neoplasms
Intervention  ICMJE Drug: PF-03446962
PF 03446962 given by a 1 hour IV infusion. Each patient will initially receive the first dose on Cycle 1 Day 1 with a 28 day observation period. Cycle 2 will start on Day 29. The dosing interval will be 14 days for Cycle 2 and subsequent cycles.
Study Arms  ICMJE Experimental: A
PF-03446962
Intervention: Drug: PF-03446962
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: April 7, 2014)		36
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2011)		38
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of stomach cancer
  • advanced/metastasis solid tumor refractory or intolerant to established therapy
  • adequate blood chemistry, blood counts and kidney/liver function
  • willing to participate to study requirements and sign an informed consent document

Exclusion Criteria:

  • Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication
  • 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 NCT01337050
Other Study ID Numbers  ICMJE A8471004
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 CenterPfizer
PRS Account Pfizer
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP