A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors
NCT ID: NCT03854227
Last Updated: 2025-01-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
54 participants
INTERVENTIONAL
2019-03-14
2022-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dose Escalation
Participants will receive PF-06939999 orally at escalating doses in 28 day cycles on a continuous basis
PF-06939999 dose escalation
PF-06939999 orally at escalating doses on a continuous basis
Non small cell lung cancer monotherapy
Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
PF-06939999 monotherapy
PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
Urothelial carcinoma
Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
PF-06939999 monotherapy
PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
Head and neck squamous cell carcinoma
Participants will receive PF-06939999 at the recommended Phase 2 dose in 28 day cycles on a continuous basis
PF-06939999 monotherapy
PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
Non small cell lung cancer PF-06939999 plus docetaxel
Participants will receive PF-06939999 on a continuous basis in combination with docetaxel
PF-06939999 in combination with docetaxel
PF-06939999 orally on a continuous basis in combination with docetaxel
Non small cell lung cancer dose finding
Participants will receive PF-06939999 on a continuous basis at escalating doses in combination with docetaxel
PF-06939999 in combination with docetaxel
PF-06939999 orally on a continuous basis in combination with docetaxel
Interventions
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PF-06939999 dose escalation
PF-06939999 orally at escalating doses on a continuous basis
PF-06939999 monotherapy
PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
PF-06939999 in combination with docetaxel
PF-06939999 orally on a continuous basis in combination with docetaxel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progressed after at least 1 line of treatment and no more than 3 lines of treatment
* At least one measurable lesion as defined by RECIST version 1.1
* ECOG Performance Status 0 or 1
* Adequate Bone Marrow Function
* Adequate Renal Function
* Adequate Liver Function
* Resolved acute effects of any prior therapy
Exclusion Criteria
* Major surgery, radiation therapy, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry.
* Active, uncontrolled infection, including COVID-19
* Known or suspected hypersensitivity to PF-06939999
* Inability to consume or absorb study drug
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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Scottsdale Healthcare Hospitals d/b/a HonorHealth
Scottsdale, Arizona, United States
Virginia G. Piper Cancer Pharmacy
Scottsdale, Arizona, United States
Keck Hospital of USC
Los Angeles, California, United States
LAC + USC Medical Center
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Keck Medical Center of USC Pasadena
Pasadena, California, United States
AdventHealth Celebration Infusion Center
Celebration, Florida, United States
AdventHealth Medical Group Oncology Research at Celebration
Celebration, Florida, United States
University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida, United States
AdventHealth Orlando - Investigational Drug Services
Orlando, Florida, United States
AdventHealth Orlando Infusion Center
Orlando, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
St. Joseph Mercy Brighton
Brighton, Michigan, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Oncology IDS Pharmacy
Nashville, Tennessee, United States
The University of Texas
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Guo C, Liao KH, Li M, Wang IM, Shaik N, Yin D. PK/PD model-informed dose selection for oncology phase I expansion: Case study based on PF-06939999, a PRMT5 inhibitor. CPT Pharmacometrics Syst Pharmacol. 2023 Nov;12(11):1619-1625. doi: 10.1002/psp4.12882. Epub 2022 Nov 16.
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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C3851001
Identifier Type: -
Identifier Source: org_study_id
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