A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors
NCT ID: NCT02222922
Last Updated: 2020-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
138 participants
INTERVENTIONAL
2014-10-17
2019-11-05
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Study Groups
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PF-06647020 Q3W
Investigational drug infused over 60 minutes once every 21 days.
PF-06647020 Q3W
Part 1: PF-06647020 will be administered intravenously every 21 days in cohorts of 2-4 patients starting at a dose of 0.20mg/kg. Increases in dose will continue until MTD is determined.
Part 2: Patients with triple negative breast cancer (pre-selected for PTK7 moderately high to high expression), non small cell lung cancer (pre-selected with moderate to high PTK7 expression) and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.
Drug-drug interaction (DDI)
PF-06647020 combined with fluconazole
fluconazole
combination drug used for drug-drug interaction sub-study
PF-06647020 Q2W
Investigational drug infused over 60 minutes once every 14 days (28 day cycle)
PF-06647020 Q2W
Part 1: PF-06647020 will be administered intravenously every 14 days in cohorts of 2-4 patients starting at a dose of 2.1 mg/kg. Increases in dose will continue until MTD is determined.
Part 2: Patients with non-small cell lung cancer (pre-selected for PTK7 moderate to high expression and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.
PF-06647020 combined with Avelumab
PF-06647020 combined with Avelumab administered by infusion
PF-06647020 combined with Avelumab
Part 2: Patients with ovarian cancer (unselected for PTK7 expression) will be treated with PF-0664702 plus Avelumab.
Interventions
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PF-06647020 Q3W
Part 1: PF-06647020 will be administered intravenously every 21 days in cohorts of 2-4 patients starting at a dose of 0.20mg/kg. Increases in dose will continue until MTD is determined.
Part 2: Patients with triple negative breast cancer (pre-selected for PTK7 moderately high to high expression), non small cell lung cancer (pre-selected with moderate to high PTK7 expression) and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.
fluconazole
combination drug used for drug-drug interaction sub-study
PF-06647020 Q2W
Part 1: PF-06647020 will be administered intravenously every 14 days in cohorts of 2-4 patients starting at a dose of 2.1 mg/kg. Increases in dose will continue until MTD is determined.
Part 2: Patients with non-small cell lung cancer (pre-selected for PTK7 moderate to high expression and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.
PF-06647020 combined with Avelumab
Part 2: Patients with ovarian cancer (unselected for PTK7 expression) will be treated with PF-0664702 plus Avelumab.
Eligibility Criteria
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Inclusion Criteria
* Performance Status of 0, 1, or 2
* Adequate bone marrow, kidney, and liver function
* Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
* Performance Status of 0 or 1
* Adequate bone marrow, kidney, and liver function
* Part 2 includes ovarian cancer, target expressing triple negative breast cancer and non small cell lung cancer patients
Exclusion Criteria
* Brain metastases requiring steroids
* Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
* Active and clinically significant bacterial, fungal, or viral infection
* OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, prior radiotherapy to pelvis/abdomen, pts with CA-125 only disease, unresolved bowel obstruction
* Brain metastases requiring steroids
* Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
* Active and clinically significant bacterial, fungal, or viral infection
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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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Stanford Cancer Center
Stanford, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
University of Chicago Medicine
Chicago, Illinois, United States
START Midwest
Grand Rapids, Michigan, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Inova Fairfax Hospital Woodburn GYN Infusion Center
Annandale, Virginia, United States
Mid Atlantic Gynecologic Oncology and Pelvic Surgery Associates (MAGOPSA)
Annandale, Virginia, United States
Fairfax Radiological Consultants
Fairfax, Virginia, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Inova Loudon Hospital
Leesburg, Virginia, United States
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario Madrid Sanchinarro
Madrid, , Spain
Countries
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References
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Johnson M, El-Khoueiry A, Hafez N, Lakhani N, Mamdani H, Rodon J, Sanborn RE, Garcia-Corbacho J, Boni V, Stroh M, Hannah AL, Wang S, Castro H, Spira A. Phase I, First-in-Human Study of the Probody Therapeutic CX-2029 in Adults with Advanced Solid Tumor Malignancies. Clin Cancer Res. 2021 Aug 15;27(16):4521-4530. doi: 10.1158/1078-0432.CCR-21-0194. Epub 2021 Jun 3.
Maitland ML, Sachdev JC, Sharma MR, Moreno V, Boni V, Kummar S, Stringer-Reasor E, Lakhani N, Moreau AR, Xuan D, Li R, Powell EL, Jackson-Fisher A, Bowers M, Alekar S, Xin X, Tolcher AW, Calvo E. First-in-Human Study of PF-06647020 (Cofetuzumab Pelidotin), an Antibody-Drug Conjugate Targeting Protein Tyrosine Kinase 7, in Advanced Solid Tumors. Clin Cancer Res. 2021 Aug 15;27(16):4511-4520. doi: 10.1158/1078-0432.CCR-20-3757. Epub 2021 Jun 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2014-003296-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7661001
Identifier Type: -
Identifier Source: org_study_id