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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00666926
Registration number
NCT00666926
Ethics application status
Date submitted
26/03/2008
Date registered
25/04/2008
Date last updated
21/03/2013
Titles & IDs
Public title
Study Of PF-00562271, Including Patients With Pancreatic, Head And Neck, Prostatic Neoplasms
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Scientific title
A Phase 1, Open-Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of PF-00562271 In Patients With Advanced Non-Hematologic Malignancies
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Secondary ID [1]
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A8031001
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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:
Head and Neck Neoplasm
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Prostatic Neoplasm
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Pancreatic Neoplasm
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Condition category
Condition code
Cancer
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Prostate
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Cancer
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Pancreatic
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Cancer
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Head and neck
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PF00562271
Treatment: Drugs - PF00562271
Treatment: Drugs - PF00562271
Treatment: Drugs - PF00562271
Experimental: 1 -
Experimental: 2 -
Experimental: 3 -
Experimental: 4 -
Treatment: Drugs: PF00562271
125 mg twice daily [BID] with food, tablet
Treatment: Drugs: PF00562271
125 mg BID with food, tablet
Treatment: Drugs: PF00562271
125 mg BID with food, tablet
Treatment: Drugs: PF00562271
125 mg BID with food, tablet
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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 First Cycle Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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At least possibly attributable to study treatment (Tx): Grade (Gr) 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) for >7 days or Gr 3 febrile neutropenia (ANC <1000/mm^3, fever =38 degrees Celsius; Gr 4 thrombocytopenia (platelets <25,000 cells/mm^3); Gr =3 non-hematologic toxicity despite adequate medical intervention; Gr =3 confirmed prolonged QTc interval (>500 milliseconds [msec]); confirmed cardiac troponin I =99 percentile of reference range; Tx related toxicities with failure to receive =18 days Tx in 21-day cycle or inability to resume current dose level =14 days.
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Timepoint [1]
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Baseline up to Cycle 1 Day 21 (C1.D21)
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Primary outcome [2]
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Percentage of Participants With Tumor Metabolic Response (Reduction of =15%) in Positron Emission Tomography With F-18-fluorodeoxyglucose (FDG-PET)
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Assessment method [2]
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Metabolic response demonstrated in any tumor reduction of =15% in tumor FDG standardized uptake value (SUV) in Cycle 1; based on the recommendations of the European Organization for Research and Treatment of Cancer (EORTC) PET Study Group. Participant must have had a baseline PET with at least 1 tumor lesion demonstrating an FDG SUV of =5.
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Timepoint [2]
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Baseline, C1.D14
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Secondary outcome [1]
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Maximum Serum Concentration (Cmax): PF-00562271 C0.D1, C1.D1
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Assessment method [1]
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Timepoint [1]
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Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 morning (am) dose
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Secondary outcome [2]
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Maximum Serum Concentration (Cmax): PF-00562271 C1.D14
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Assessment method [2]
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Timepoint [2]
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Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose
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Secondary outcome [3]
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Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C0.D1, C1.D1
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Assessment method [3]
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Timepoint [3]
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Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose
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Secondary outcome [4]
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Time to Reach Maximum Observed Serum Concentration (Tmax): PF-00562271 C1.D14
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Assessment method [4]
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Timepoint [4]
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Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose
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Secondary outcome [5]
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-00562271 C0.D1, C1.D1
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Assessment method [5]
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Area under the serum concentration time-curve from zero to the last measured concentration; nanograms multiplied by hours per milliliters (ng*hr/mL).
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Timepoint [5]
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Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose
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Secondary outcome [6]
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Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): PF-00562271 C0.D1, C1.D1
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Assessment method [6]
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AUCinf = area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
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Timepoint [6]
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Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose
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Secondary outcome [7]
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Serum Decay Half-life (t 1/2): PF-00562271 C0.D1, C1.D1
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Assessment method [7]
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Serum decay half-life is the time measured for the serum concentration to decrease by one half.
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Timepoint [7]
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Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose
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Secondary outcome [8]
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Apparent Oral Clearance (CL/F): PF-00562271 C0. D1, C1.D1
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Assessment method [8]
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Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
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Timepoint [8]
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Escalation cohorts: C0.D1 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hrs post dose; Expansion E1 US cohort: C1.D1 0 hr (prior to MDZ dose); E1 non-US and E2 cohort: C1.D1 0 hr and 0.5, 1, 2, 4 hrs post C1.D1 am dose
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Secondary outcome [9]
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Minimum Observed Serum Trough Concentration (Cmin): PF-00562271 C1.D14
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Assessment method [9]
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Timepoint [9]
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Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose
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Secondary outcome [10]
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Area Under the Curve From Time Zero to the End of the Dosing Interval (AUCtau): PF-00562271 C1.D14
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Assessment method [10]
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Timepoint [10]
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Escalation and Expansion E1 and E2 cohorts: C1.D14 0 hour (0 hr=pre-dose PF-00562271), and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose
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Secondary outcome [11]
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Observed Accumulation Ratio (Rac): PF-00562271 C1.D14
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Assessment method [11]
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Rac was the ratio of the Day 14 AUC0-tau (0 hour to last dose interval) and AUC during the corresponding time period after the lead-in dose (AUCtau C1.D14/AUCtau C0.D1).
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Timepoint [11]
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Escalation (Esc) cohort: C0.D1: 0 hr, and 0.5, 1, 2, 4, 6, 7,12 hrs post dose; Expansion (Exp) cohort: C0:D1: 0 hr, and 1, 2, 4, 8 hrs post dose; Esc and Exp cohorts: C1.D14 0 hour, and 0.5, 1, 2, 4, 6, 8, 12 (if BID) or 24 (if QD) hrs post am dose
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Secondary outcome [12]
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Maximum Serum Concentration (Cmax): MDZ
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Assessment method [12]
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Timepoint [12]
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C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose
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Secondary outcome [13]
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): MDZ
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Assessment method [13]
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Area under the serum concentration time-curve from zero to the last measured concentration.
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Timepoint [13]
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C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose
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Secondary outcome [14]
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Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf): MDZ
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Assessment method [14]
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AUCinf = area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
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Timepoint [14]
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C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose
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Secondary outcome [15]
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Time to Reach Maximum Observed Serum Concentration (Tmax): MDZ
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Assessment method [15]
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Timepoint [15]
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C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose
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Secondary outcome [16]
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Serum Decay Half-life (t 1/2): MDZ
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Assessment method [16]
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Serum decay half-life is the time measured for the serum concentration to decrease by one half.
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Timepoint [16]
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C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose
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Secondary outcome [17]
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Apparent Oral Clearance (CL/F): MDZ
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Assessment method [17]
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Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
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Timepoint [17]
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C0.D1, C1.D21 Expansion cohort E1 US sites only: 0 hr (prior to MDZ dosing) and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hrs post MDZ dose
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Secondary outcome [18]
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Percentage of Participants With Best Overall Response as Measured Using the Response Evaluation Criteria in Solid Tumors (RECIST)
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Assessment method [18]
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Best response recorded from start of treatment (Tx) until disease progression. Complete response: disappearance of all target lesions. Partial response: =30% decrease in sum of longest dimensions (LD) of target lesions referencing baseline sum LD. Progressive disease: =20% increase in sum LD of target lesions from smallest sum LD recorded since Tx start or appearance of =1 new lesions. Stable disease: neither sufficient shrinkage to=PR nor sufficient increase to=PD during first 6 weeks after Tx start referencing smallest sum LD since Tx start.
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Timepoint [18]
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Baseline up to 12 cycles (cycle=21days)
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Secondary outcome [19]
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Phosphorylated Focal Adhesion Kinase (pFAK)
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Assessment method [19]
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Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; FAK is overexpressed in a variety of human cancers. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.
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Timepoint [19]
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Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)
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Secondary outcome [20]
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Phosphorylated Mitogen Activated Pathway Kinase (pMAPK)
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Assessment method [20]
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Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; MAPK regulates activities of several transcription factors. A defect in MAPK pathway leads to uncontrolled cell growth. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.
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Timepoint [20]
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Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)
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Secondary outcome [21]
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Phospho-SRC (pSRC)
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Assessment method [21]
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Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; SRC proto-oncogenes are regulators of growth and differentiation of eukaryotic cells and are implicated in development of human tumors. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose; on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.
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Timepoint [21]
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Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)
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Secondary outcome [22]
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Caspase-3
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Assessment method [22]
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Analysis of tumor specimens to assess FAK-related biomarkers for potential predictors of response markers to PF-00562271; sequential activation of caspases plays a central role in the execution-phase of cell apoptosis. For dose escalation cohorts and expansion cohort E1, pre-treatment tumor biopsy collected between Day -28 and first PF-00562271 dose and on-treatment tumor biopsy collected 2 to 8 hours after PF-00562271 dose during Cycle 1 between day 12 and 16. In addition, up to 10 participants in cohort E2 were to be enrolled for serial biopsies.
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Timepoint [22]
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Baseline (up to 28 days prior to first dose) up to 12 cycles (cycle=21days)
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Eligibility
Key inclusion criteria
- Pancreatic, head and neck, and prostatic neoplasms, and patients with non-hematologic
malignancies who have tumor appropriate for serial biopsy.
- Adequate organ function, including bilirubin less than 1.5 x ULN, and [Eastern
Cooperative Oncology Group] ECOG performance status of 0-2.
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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
- Clinically significant gastrointestinal abnormalities, requirement for systemic
anticoagulants or potent CYP 3A4 inhibitors, and history of clinically significant
cardiac or pulmonary disorders.
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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
Crossover
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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
Completed
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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
1/12/2005
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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
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Actual
1/04/2009
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Sample size
Target
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Accrual to date
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Final
99
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Pfizer Investigational Site - East Melbourne
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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Country [2]
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United States of America
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State/province [2]
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Tennessee
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Country [3]
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Canada
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State/province [3]
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Ontario
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Verastem, Inc.
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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
Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase
(FAK) inhibitor PF-00562271 in patients with positive Positron Emission Tomography [PET]
scans due to advanced non-hematologic malignancies, including pancreatic, head and neck, and
prostatic neoplasms, and patients with other malignancies appropriate for serial biopsy.
Screening consists of a Fluorodeoxyglucose Positron Emission Tomography [FDG-PET] and tumor
imaging, medical history, physical examination, Eastern Cooperative Oncology Group [ECOG]
performance status, blood draws, a pregnancy test for female patients of childbearing
potential. Treatment consists of PF00562271 tablets continued until progression of disease,
unacceptable toxicity, or patient request. Evaluations for bioactivity are measured by serial
FDG-PET and blood tests for biomarkers related to FAK and PYK2 kinase activities.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00666926
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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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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
0
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00666926
Download to PDF