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Asian Phase I Study Of PF-03446962

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NCT01337050

Last updated on May 9, 2018
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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
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

NCT01337050
Pfizer
Completed
Asian Phase I Study Of PF-03446962

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Asian Phase I Study Of PF-03446962
A Phase I Pharmacokinetic And Pharmacodynamic Study Of Pf-03446962 In Asian Patient With Advanced Solid Tumors
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].
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Neoplasms
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.
Experimental: A
PF-03446962
Intervention: Drug: PF-03446962
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2014
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of
 
 
NCT01337050
A8471004
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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