A First In Patient, Study Of Investigational Drug PF-03446962 In Patients With Advanced Solid Tumors
NCT ID: NCT00557856
Last Updated: 2015-10-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
70 participants
INTERVENTIONAL
2007-11-30
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Hollings Cancer Center
Charleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
S.C Diagnostica Radiologica 2
Milan, , Italy
S.C. Chirurgia Generale Indirizzo Oncologico 1 (epato-gastro-pancreatica)
Milan, , Italy
S.C. Medicina Oncologica I, Fondazione IRCCS Istituto Nazionale Tumori
Milan, , Italy
Dipartimento di Medicina
Milan, , Italy
UO di Oncologia ed Ematologia, Istituto Clinico Humanitas-Humanitas Cancer Center
Rozzano (MI), , Italy
Seoul National University Hospital / Department of Internal Medicine
Seoul, , South Korea
Countries
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References
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Simonelli M, Zucali P, Santoro A, Thomas MB, de Braud FG, Borghaei H, Berlin J, Denlinger CS, Noberasco C, Rimassa L, Kim TY, English PA, Abbattista A, Gallo Stampino C, Carpentieri M, Williams JA. Phase I study of PF-03446962, a fully human monoclonal antibody against activin receptor-like kinase-1, in patients with hepatocellular carcinoma. Ann Oncol. 2016 Sep;27(9):1782-7. doi: 10.1093/annonc/mdw240. Epub 2016 Jun 20.
Goff LW, Cohen RB, Berlin JD, de Braud FG, Lyshchik A, Noberasco C, Bertolini F, Carpentieri M, Stampino CG, Abbattista A, Wang E, Borghaei H. A Phase I Study of the Anti-Activin Receptor-Like Kinase 1 (ALK-1) Monoclonal Antibody PF-03446962 in Patients with Advanced Solid Tumors. Clin Cancer Res. 2016 May 1;22(9):2146-54. doi: 10.1158/1078-0432.CCR-15-1622. Epub 2015 Dec 11.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2007-001422-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A8471001
Identifier Type: -
Identifier Source: org_study_id
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