PF-06671008 Dose Escalation Study in Advanced Solid Tumors

NCT02659631

Last updated date
Study Location
Memorial Sloan Kettering Cancer Center - Westchester
Harrison, New York, 10604, United States
Contact
1-800-718-1021

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By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
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

- Diagnosis of tumor type with the potential to have P-cadherin expression that is resistant to standard therapy or for which no standard therapy is available

- Performance status of 0 or 1

- Adequate bone marrow, kidney and liver function

Key

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


- Known CNS disease including, but not limited to, metastases


- Current or history of seizure disorder


- History of or active autoimmune disorders


- Active bacterial, fungal or viral infection


- Major surgery, anti-cancer therapy, or radiation therapy within 4 weeks of study
treatment


- Requirement for systemic immune suppressive medication


- Grade 2 or greater peripheral neuropathy

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Advanced Information
Descriptive Information
Brief Title  ICMJE PF-06671008 Dose Escalation Study in Advanced Solid Tumors
Official Title  ICMJE A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06671008 IN PATIENTS WITH ADVANCED SOLID TUMORS
Brief Summary The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06671008 in patients with advanced solid tumors with the potential to have P-cadherin expression. The study will then expand to look at the selected dose in patients with P-cadherin expressing TNBC, CRC or NSCLC.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • Drug: PF-06671008
    Dose Escalation Phase - Part 1
  • Drug: PF-06671008
    Dose Expansion Phase - Part 2
Study Arms  ICMJE Experimental: PF-06671008
Interventions:
  • Drug: PF-06671008
  • Drug: PF-06671008
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 Terminated
Actual Enrollment  ICMJE
 (submitted: November 9, 2018)
28
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2016)
110
Actual Study Completion Date  ICMJE March 29, 2019
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria

  • Diagnosis of tumor type with the potential to have P-cadherin expression that is resistant to standard therapy or for which no standard therapy is available
  • Performance status of 0 or 1
  • Adequate bone marrow, kidney and liver function

Key Exclusion Criteria

  • Known CNS disease including, but not limited to, metastases
  • Current or history of seizure disorder
  • History of or active autoimmune disorders
  • Active bacterial, fungal or viral infection
  • Major surgery, anti-cancer therapy, or radiation therapy within 4 weeks of study treatment
  • Requirement for systemic immune suppressive medication
  • Grade 2 or greater peripheral neuropathy
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02659631
Other Study ID Numbers  ICMJE B7831001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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 April 2020

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