A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors
NCT00557856
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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
- 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
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Descriptive Information | ||||
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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 Summary | The 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 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 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 * |
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* 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 | 70 | |||
Original Enrollment ICMJE | 60 | |||
Actual Study Completion Date ICMJE | March 2013 | |||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
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 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 |
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PRS Account | Pfizer | |||
Verification Date | September 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |