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A Study of PF-07265807 In Participants With Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04458259
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
First-in-human study to assess safety, tolerability, PK, and preliminary activity of PF-07265807 in participants with selected advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Drug: PF-07265807 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose Escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic, Safety, and Tolerability Study of PF 07265807 in Participants With Advanced or Metastatic Solid Tumors
Estimated Study Start Date : July 8, 2020
Estimated Primary Completion Date : March 17, 2023
Estimated Study Completion Date : March 17, 2023

Arm Intervention/treatment
Experimental: Dose Level 1
Participants will receive PF-07265807 at 25 mg once a day (QD) 2 weeks on/1 week off
Drug: PF-07265807
25 mg QD 2 weeks on/1 week off

Experimental: Dose Level 2
Participants will receive PF-07265807 at 50 mg QD 2 weeks on/1 week off
Drug: PF-07265807
50 mg QD 2 weeks on/1 week off

Experimental: Dose Level 3
Participants will receive PF-07265807 at 100 mg QD 2 weeks on/1 week off
Drug: PF-07265807
100 mg QD 2 weeks on/1 week off

Experimental: Dose Level 4
Participants will receive PF-07265807 at 200 mg QD 2 weeks on/1 week off
Drug: PF-07265807
200 mg QD 2 weeks on/1 week off

Experimental: Dose Level 5
Participants will receive PF-07265807 at 300 mg QD 2 weeks on/1 week off
Drug: PF-07265807
300 mg QD 2 weeks on/1 week off




Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Baseline through day 42 ]
    DLTs will be evaluated during the first two cycles (day 42). The number of DLTs will be used to determine the maximum tolerated dose (MTD)

  2. Number of participants with treatment emergent adverse events (AEs) [ Time Frame: Baseline through approximately 2 years ]
    AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy

  3. Number of participants with laboratory abnormalities [ Time Frame: Baseline through approximately 2 years ]
    Laboratory abnormalities as characterized by type, frequency, severity, and timing.


Secondary Outcome Measures :
  1. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Single dose PK will be calculated including Maximum Observed Plasma Concentration (Cmax)

  2. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Single dose PK will be calculated including time to reach Maximum Observed Plasma Concentration (Tmax)

  3. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Single dose PK will be calculated including Area Under the Curve from time 0 to the last sampling time point within the dose interval (AUClast)

  4. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Single dose PK will be calculated including, as data permit, terminal elimination half life (t1/2)

  5. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Single dose PK will be calculated including, as data permit, Area Under the Curve from time 0 extrapolated to infinity (AUCinf)

  6. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Single dose PK will be calculated including, as data permit, Area Under the Curve from the time of dose to the time of the subsequent dose (AUCtau)

  7. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Single dose PK will be calculated including, as data permit, apparent oral plasma clearance (CL/F)

  8. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Single dose PK will be calculated including, as data permit, apparent volume of distribution (Vz/F)

  9. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Multiple dose PK will be calculated including Maximum Observed Steady State Plasma Concentration (Css,max)

  10. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Multiple dose PK will be calculated including Time to reach Maximum Observed Steady State Plasma Concentration (Tss,max)

  11. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Multiple dose PK will be calculated including Area Under the Curve from the time of dose to the time of the subsequent dose at steady state (AUCss,tau)

  12. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Multiple dose PK will be calculated including, as data permit, apparent oral plasma clearance (CL/F)

  13. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Multiple dose PK will be calculated including, as data permit, apparent volume of distribution at steady state (Vss/F)

  14. Pharmacokinetic Parameters [ Time Frame: Each cycle is 21 days. Cycle 1 Days 1 and 14, predose, 0.5,1,2,4,8 and 24 hours post dose; Day 7 predose and 2 hours post dose; Cycle 2 Days 1 and 14, predose and 2 hours post dose; Cycles 3-6 Days 1 and 14 predose ]
    Multiple dose PK will be calculated including, as data permit, accumulation ratio (Rac)

  15. Objective Response Rate [ Time Frame: Baseline through up to 24 months ]
    Tumor response as assessed using RECIST 1.1

  16. Duration of Response (DOR) [ Time Frame: Baseline through up to 24 months ]
    Duration of response as assessed using RECIST 1.1



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who are intolerant or resistant to standard treatment for selected solid tumors
  • at least one measurable or non-measurable lesion, not previously irradiated, as defined by RECIST 1.1
  • ECOG Performance Status 0 or 1, 2 with approval
  • Adequate Bone Marrow Function
  • Adequate Renal Function
  • Adequate Liver Function
  • Resolved acute effects of any prior therapy

Exclusion Criteria:

  • Known active uncontrolled or symptomatic CNS metastases
  • Major surgery within 6 weeks, radiation therapy within 4 weeks, systemic anti-cancer therapy within 2 week or 5 half-lives (4 weeks or 5 half-lives for antibody therapies or investigational drug(s) taken on another study) prior to study entry
  • Active or history of autoimmune disease requiring >10mg/day prednisone or other concurrent immunosuppressive therapy
  • Active, uncontrolled infection (controlled HBV, HCV, HIV/AIDS may be allowed) as defined in protocol
  • Retinal or other serious ophthalmic disorders as defined in protocol
  • Clinically significant cardiac disease as defined in protocol
  • Inability to consume or absorb study drug
  • Known or suspected hypersensitivity to PF-07265807
  • Prohibited concomitant medications as defined in protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458259


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04458259    
Other Study ID Numbers: C4201002
ARRAY-067-102 ( Other Identifier: Alias Study Number )
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
TAMK (TAM kinase)
MER (mer proto-oncogene)
MERTK (mer proto-oncogene tyrosine kinase)
AXL (AXL receptor tyrosine kinase)
AXL/MER
selective kinase inhibitor
PD-1 (programmed cell death protein 1)
PD-L1 (programmed cell death ligand 1)
immune modulator
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes