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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04152018
Registration number
NCT04152018
Ethics application status
Date submitted
30/10/2019
Date registered
5/11/2019
Titles & IDs
Public title
Study of PF-06940434 in Patients With Advanced or Metastatic Solid Tumors.
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Scientific title
A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES OF PF-06940434 IN PATIENTS WITH ADVANCED OR METASTATIC SOLID TUMORS
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Secondary ID [1]
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2020-004009-29
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Secondary ID [2]
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C3891001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Head and Neck
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Renal Cell Carcinoma
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Ovarian Cancer
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Gastric Cancer
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0
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Esophageal Cancer
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0
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Lung Squamous Cell Carcinoma
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0
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Pancreatic Cancer
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0
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Bile Duct Cancer
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0
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Endometrial Cancer
0
0
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Melanoma Cancer
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0
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Urothelial Cancer
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0
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Condition category
Condition code
Cancer
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0
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0
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Non melanoma skin cancer
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Cancer
0
0
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0
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Kidney
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Cancer
0
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0
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Womb (Uterine or endometrial cancer)
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Cancer
0
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Head and neck
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Cancer
0
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Biliary tree (gall bladder and bile duct)
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PF-06940434
Treatment: Drugs - PF-06801591
Experimental: Dose Escalation - Single Agent Dose Escalation
Experimental: Dose Finding Anti-PD-1 Combination 1 - Part 1B PF-06940434 plus anti-PD-1
Experimental: Dose Expansion Arm A - PF-06940434 with anti-PD-1 in SCCHN
Experimental: Dose Expansion Arm B - PF-06940434 with anti-PD-1 in RCC
Experimental: Dose Expansion, Arm C - PF-06940434 with anti-PD-1 (both Q3W)
Treatment: Drugs: PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated
Treatment: Drugs: PF-06801591
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with Dose-limiting toxicities (DLT) for Dose Escalation and Dose Finding
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Assessment method [1]
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Timepoint [1]
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Baseline up to 28 Days (Cycle 1)
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Primary outcome [2]
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Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
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Assessment method [2]
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Timepoint [2]
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Baseline up to approximately 24 months
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Primary outcome [3]
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Number of Participants With Adverse Events (AEs) According to Severity
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Assessment method [3]
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Timepoint [3]
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Baseline up to approximately 24 months
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Primary outcome [4]
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Number of Participants With Adverse Events (AEs) According to Seriousness
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Assessment method [4]
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Timepoint [4]
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Baseline up to up to approximately 24 months
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Primary outcome [5]
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Number of Participants With Adverse Events (AEs) by Relationship
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Assessment method [5]
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Timepoint [5]
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Baseline up to approximately 24 months
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Primary outcome [6]
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Progression-Free Survival (PFS) for Dose Expansion
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Assessment method [6]
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The period from study entry until disease progression, death or date of last contact.
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Timepoint [6]
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Baseline up to 24 Months
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Primary outcome [7]
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Objective Response Rate - Percentage of Participants With Objective Response in Dose Expansion
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Assessment method [7]
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Timepoint [7]
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Baseline up to 24 months
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Primary outcome [8]
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Duration of Response (DR) for Dose Expansion
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Assessment method [8]
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Timepoint [8]
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Baseline up to 24 Months
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Secondary outcome [1]
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PF-06940434 after multiple doses PK parameters (Cmax).
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Assessment method [1]
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Maximum observed plasma concentration of PF-06940434.
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Timepoint [1]
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Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
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Secondary outcome [2]
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Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434.
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Assessment method [2]
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Time zero extrapolated to the last quantifiable time point prior to the next dose.
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Timepoint [2]
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Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
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Secondary outcome [3]
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Systemic Clearance (CL)
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Assessment method [3]
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CL is a quantitative measure of the rate at which a drug substance is removed from the body.
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Timepoint [3]
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Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
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Secondary outcome [4]
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Volume of Distribution (Vd)
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Assessment method [4]
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Timepoint [4]
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Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
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Secondary outcome [5]
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Incidence and titers of anti-drug antibodies (ADA) against PF-06940434.
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Assessment method [5]
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Timepoint [5]
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Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
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Secondary outcome [6]
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Incidence and titers of neutralizing antibodies (NAb) against PF-06940434.
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Assessment method [6]
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Titers of neutralizing antibodies (NAb) against PF-06940434.
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Timepoint [6]
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Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
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Secondary outcome [7]
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PK parameters of PF-06940434 and PF-06801591 (Cmax).
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Assessment method [7]
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Maximum observed plasma concentration after multiple doses of PF-06940434 and PD-1 (PF-06801591).
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Timepoint [7]
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Pre-dose on Cycle 1 Day 1 and on day 15 of Cycle 1; Day 1 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days)
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Secondary outcome [8]
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Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591.
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Assessment method [8]
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Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591.
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Timepoint [8]
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Pre-dose on Cycle 1 Day 1 and on day 15 of Cycle 1; Day 1 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days)
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Secondary outcome [9]
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Characterize the multiple dose PK of PF-06940434 following intravenous administration in combination with PF-06801591.
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Assessment method [9]
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Maximum observed plasma concentration of PF-06940434.
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Timepoint [9]
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Cycle 4 Day 1 (each cycle is 28 days)
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Secondary outcome [10]
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Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434.
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Assessment method [10]
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Time zero extrapolated to the last quantifiable time point prior to the next dose.
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Timepoint [10]
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Cycle 4 Day 1 (each cycle is 28 days)
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Secondary outcome [11]
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Number of participants with increased T-cells after PF-06940434 treatment.
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Assessment method [11]
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Timepoint [11]
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Pre-dose on Day 1 of Cycle 1; pre-dose on Day 1 of Cycles 2 and 3 (each cycle is 28 days)
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Secondary outcome [12]
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Progression-Free Survival (PFS) for Dose Expansion
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Assessment method [12]
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The period from study entry until disease progression, death or date of last contact.
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Timepoint [12]
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Baseline to measured progression (up to approximately 24 months)
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Secondary outcome [13]
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Duration of Response (DR)
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Assessment method [13]
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Timepoint [13]
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Baseline up to approximately 24 Months
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Secondary outcome [14]
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Number of Participants With Objective Response for Dose Expansion portion
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Assessment method [14]
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Timepoint [14]
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Baseline up to 24 months
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Secondary outcome [15]
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Disease Control Rate (DCR)
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Assessment method [15]
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DCR is defined as the percent of participants with a confirmed complete response (CR), partial response (PR) or stable disease (SD) according to RECIST 1.1.
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Timepoint [15]
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Every 8 weeks from the time of enrollment up to 2 years
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Secondary outcome [16]
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Trough concentrations of PF-06940434 and PF-06801591 in Dose Expansion
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Assessment method [16]
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Timepoint [16]
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Day 1 of Cycle 1 though 4, Day 1 of every 2 Cycles starting from Cycle 5 up to 24 months (each cycle is 28 days). For Part 2 Cohort 3, Day 1 of Every Cycle (each cycle is 21 days)
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Secondary outcome [17]
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Plasma Decay Half-Life (t1/2)
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Assessment method [17]
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Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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Timepoint [17]
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Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days]
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Secondary outcome [18]
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Incidence and titers of anti-drug antibodies (ADA) against PF-06801591 in Dose Finding and Dose Expansion
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Assessment method [18]
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Incidence and titers of anti-drug antibodies (ADA) against PF-06801591.
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Timepoint [18]
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Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days].
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Secondary outcome [19]
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Incidence and titers of neutralizing antibodies (NAb) against PF-06801591 in Dose Finding and Dose Expansion.
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Assessment method [19]
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Incidence and titers of neutralizing antibodies (NAb) against PF-06801591.
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Timepoint [19]
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Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days].
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Secondary outcome [20]
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Overall Survival
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Assessment method [20]
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The period from study entry until death or date of last contact (24 months)
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Timepoint [20]
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From baseline to up to 2 years after last dose of study drug
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Eligibility
Key inclusion criteria
- Histological or cytological diagnosis of SCCHN, RCC (clear cell and papillary cell), ovarian, gastric, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma, or urothelial cancer.
Part 2:
* Arm A SCCHN:
* Primary tumor location of the oral cavity, oropharynx, hypopharynx or larynx.
* PDL-1 expression positive and CPS =1. No prior systemic therapy administered in the recurrent or metastatic setting (except for systemic therapy given as part of a multimodal treatment for locally advanced disease).
* Arm B RCC (clear cell):
* 1 or 2 prior lines of therapy including PD-L1/PD-1 immunotherapy in combination or sequentially with antiangiogenic directed treatment
* Adequate bone marrow, kidney and liver function.
* Performance status of 0 or 1.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participant disease status is suitable for local therapy administered with curative intent.
* Hypertension that cannot be controlled by medications.
* Active or prior autoimmune disease
* Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) Hepatitis B, Hepatitis C, and known Human Immunodeficiency Virus infection or Acquired Immunodeficiency Syndrome-related illness
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/11/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
85
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Southern Medical Day Care Centre - Wollongong
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Arizona
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Country [2]
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0
United States of America
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State/province [2]
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California
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Country [3]
0
0
United States of America
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State/province [3]
0
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Maryland
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Missouri
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Country [5]
0
0
United States of America
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State/province [5]
0
0
New York
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Country [6]
0
0
United States of America
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State/province [6]
0
0
North Carolina
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Texas
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Washington
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Country [9]
0
0
Korea, Republic of
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State/province [9]
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0
Seoul-teukbyeolsi [seoul]
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Country [10]
0
0
Korea, Republic of
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State/province [10]
0
0
Seoul
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Country [11]
0
0
Slovakia
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State/province [11]
0
0
Bratislava
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Country [12]
0
0
Slovakia
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State/province [12]
0
0
Komárno
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Country [13]
0
0
Slovakia
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State/province [13]
0
0
Poprad
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Country [14]
0
0
Taiwan
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State/province [14]
0
0
Tainan
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Country [15]
0
0
Taiwan
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State/province [15]
0
0
Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06940434 (Integrin alpha-V/beta-8 Antagonist) in patients with SCCHN (Squamous Cell Carcinoma of the Head and Neck), renal cell carcinoma (RCC - clear cell and papillary), ovarian, gastric, esophageal, esophageal (adeno and squamous), lung squamous cell, pancreatic and biliary duct, endometrial, melanoma and urothelial tumors. This study contains two parts, single agent dose escalation (Part 1A), dose finding of PF 06940434 in combination with anti-PD-1 (Part 1B) and dose expansion (Part 2). Part 2 Dose Combination Expansion will enroll participants into 3 cohorts at doses determined from Part 1B in order to further evaluate the safety of PF-06940434 in combination with anti-PD-1.
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Trial website
https://clinicaltrials.gov/study/NCT04152018
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Pfizer CT.gov Call Center
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Address
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0
Pfizer
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Country
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0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04152018