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A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors

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NCT00557856

Last updated on November 12, 2019
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FOR MORE INFORMATION
Study Location
Fox Chase Cancer Center
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 Solid Tumors
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

- Advanced measurable or non-measurable solid tumors

- Adequate bone marrow function

- Adequate liver function

- Adequate renal function

- Be able and willing to comply with the study scheduled visits, treatment plans,
laboratory tests and other procedures

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

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

- Any of the following within the 12 months prior to starting study treatment:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, congestive heart failure, cerebrovascular accident including transient ischemic
attack, or pulmonary embolus; or any other active thromboembolic event

- QTc prolongation defined as QTc >450 msec

- Patients with known brain metastasis

- Patients with peritoneal carcinosis at risk of bleeding

- Major surgical procedure within 4 weeks of treatment

- Pregnancy or breastfeeding

NCT00557856
Pfizer
Completed
A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors

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Descriptive Information
Brief Title  ICMJE A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of Pf-03446962 In Patients With Advanced Solid Tumors
Brief SummaryThe purpose of this study is to test the safety and effectiveness of PF-03446962 when given as a single agent. Tumors require new blood vessels to support their ability to grow and to spread (metastasize). New treatments aimed at preventing these blood vessels have the ability to improve the clinical management of cancer.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Drug: PF-03446962
To determine the maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of PF-03446962 administered in patients with advanced solid tumors.
Study Arms  ICMJE Experimental: 1
Intervention: Drug: PF-03446962
Publications *


*   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: September 27, 2015)		70
Original Enrollment  ICMJE
 (submitted: November 12, 2007)		60
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion DateMarch 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Advanced measurable or non-measurable solid tumors
  • Adequate bone marrow function
  • Adequate liver function
  • Adequate renal function
  • Be able and willing to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures

Exclusion Criteria:

  • Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication
  • Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, hemoptysis or melena in the past 6 months
  • Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus; or any other active thromboembolic event
  • QTc prolongation defined as QTc >450 msec
  • Patients with known brain metastasis
  • Patients with peritoneal carcinosis at risk of bleeding
  • Major surgical procedure within 4 weeks of treatment
  • Pregnancy or breastfeeding
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 Italy,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00557856
Other Study ID Numbers  ICMJE A8471001
2007-001422-27 ( EudraCT Number )
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 DateSeptember 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 the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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