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A Safety Study Of A Monoclonal Antibody Against A5B1 Integrin In Solid Tumors

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NCT00915278

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111 United States
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.
Advanced Non-Hematologic Malignancies
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

- Histologically or cytologically confirmed advanced measurable or evaluable solid
tumors unresponsive to currently available therapies, or for which there is no
curative therapy

- Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1

- Life expectancy more than12 weeks

- Adequate bone marrow, liver and renal function

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

- Known brain metastasis

- Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of
start of screening procedures

- Major surgical procedure within 4 weeks of start of screening procedures

- Active bleeding disorder, including gastrointestinal bleeding, as evidenced by
hematemesis, significant hemoptysis or melena in the past 6 months

NCT00915278
Pfizer
Terminated
A Safety Study Of A Monoclonal Antibody Against A5B1 Integrin In Solid Tumors

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A Safety Study Of A Monoclonal Antibody Against A5B1 Integrin In Solid Tumors
A Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Anti-A5B1 Integrin Monoclonal Antibody PF-04605412 Administered Intravenously To Adult Patients With Advanced Or Metastatic Solid Tumors
Dose finding study of the MoaB PF-04605412 directed against the alpha5beta1 integrin. Main objective is to define the MTD (maximum tolerated dose) or MAD (maximum administrable dose) in cancer patients pre treated or unresponsive to standard therapies.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Non-Hematologic Malignancies
Drug: PF-04605412
PF-04605412 will be administered as 2 hr IV infusion every 4 or 2 weeks. Start dose is 7.5 mg. Multiple doses are foreseen. Treatment will continue until intolerable toxicity, progression of disease or patient's refusal
Experimental: PF-04605412
Intervention: Drug: PF-04605412
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
33
January 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced measurable or evaluable solid tumors unresponsive to currently available therapies, or for which there is no curative therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1
  • Life expectancy more than12 weeks
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Known brain metastasis
  • Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of start of screening procedures
  • Major surgical procedure within 4 weeks of start of screening procedures
  • Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 6 months
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom,   United States
 
 
NCT00915278
B1001001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2014

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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1-800-718-1021

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[email protected]



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