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

NCT04458259

Last updated date
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasm Metastasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Neoplasm MetastasisA Study of PF-07265807 In Participants With Advanced or Metastatic Solid Tumors
NCT04458259
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of PF-07265807 In Participants With Advanced or Metastatic Solid Tumors
Official Title  ICMJE A Pharmacokinetic, Safety, and Tolerability Study of PF 07265807 in Participants With Advanced or Metastatic Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Dose Escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasm Metastasis
Intervention  ICMJE
  • Drug: PF-07265807
    25 mg QD 2 weeks on/1 week off
  • Drug: PF-07265807
    50 mg QD 2 weeks on/1 week off
  • Drug: PF-07265807
    100 mg QD 2 weeks on/1 week off
  • Drug: PF-07265807
    200 mg QD 2 weeks on/1 week off
  • Drug: PF-07265807
    300 mg QD 2 weeks on/1 week off
Study Arms  ICMJE
  • Experimental: Dose Level 1
    Participants will receive PF-07265807 at 25 mg once a day (QD) 2 weeks on/1 week off
    Intervention: Drug: PF-07265807
  • Experimental: Dose Level 2
    Participants will receive PF-07265807 at 50 mg QD 2 weeks on/1 week off
    Intervention: Drug: PF-07265807
  • Experimental: Dose Level 3
    Participants will receive PF-07265807 at 100 mg QD 2 weeks on/1 week off
    Intervention: Drug: PF-07265807
  • Experimental: Dose Level 4
    Participants will receive PF-07265807 at 200 mg QD 2 weeks on/1 week off
    Intervention: Drug: PF-07265807
  • Experimental: Dose Level 5
    Participants will receive PF-07265807 at 300 mg QD 2 weeks on/1 week off
    Intervention: Drug: PF-07265807
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2020)
37
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 17, 2023
Estimated Primary Completion Date March 17, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04458259
Other Study ID Numbers  ICMJE C4201002
ARRAY-067-102 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP