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

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NCT00915278

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Study Location
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111, United States
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Safety Study Of A Monoclonal Antibody Against A5B1 Integrin In Solid Tumors
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Non-Hematologic Malignancies
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: PF-04605412
Intervention: Drug: PF-04605412
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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 28, 2013)		33
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2009)		60
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00915278
Other Study ID Numbers  ICMJE B1001001
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 February 2014

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