A Study Of PF-06647263 In Patients With Advanced Solid Tumors

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NCT02078752

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Study Location
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms, Triple-Negative Breast Cancer
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 solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available

- Performance Status of 0 or 1

- Adequate bone marrow, kidney, and liver function

- Part 2 includes advanced triple negative breast cancer patients.

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


- Brain metastases requiring steroids


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


- Active and clinically significant bacterial, fungal or viral infection

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Neoplasms, Triple-Negative Breast CancerA Study Of PF-06647263 In Patients With Advanced Solid Tumors NCT02078752
  1. Boston, Massachusetts
  2. Boston, Massachusetts
  3. Boston, Massachusetts
  4. Detroit, Michigan
  5. Las Vegas, Nevada
  6. Nashville, Tennessee
  7. Nashville, Tennessee
  8. Houston, Texas
  9. Salt Lake City, Utah
  10. Salt Lake City, Utah
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of PF-06647263 In Patients With Advanced Solid Tumors
Official Title  ICMJE A FIRST-IN-HUMAN PHASE 1, DOSE ESCALATION, SAFETY AND PHARMACOKINETIC STUDY OF PF-06647263 IN ADULT PATIENTS WITH ADVANCED SOLID TUMORS
Brief Summary To assess the safety and tolerability at increasing dose levels of PF-06647263 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Detailed Description The clinical study will include 2 parts. Part 1 will estimate the MTD in dose escalation cohorts in patients with advanced solid tumors for whom no standard therapy is available in order to establish the RP2D. Part 2 will include patients with previously treated metastatic triple negative breast cancer (TNBC).
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
  • Triple-Negative Breast Cancer
Intervention  ICMJE
  • Drug: PF-06647263
    Part 1- PF-06647263 will be administered intravenously in either a 21 day cycle or weekly in cohorts of 2 or more patients starting at a dose of 0.015 mg/kg. Increases in dose will continue until MTD is determined.
  • Drug: PF-06647263
    Part 2- Patients with triple negative breast cancer will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Study Arms  ICMJE Experimental: Part 1
Interventions:
  • Drug: PF-06647263
  • Drug: PF-06647263
Publications * Garrido-Laguna I, Krop I, Burris HA 3rd, Hamilton E, Braiteh F, Weise AM, Abu-Khalaf M, Werner TL, Pirie-Shepherd S, Zopf CJ, Lakshminarayanan M, Holland JS, Baffa R, Hong DS. First-in-human, phase I study of PF-06647263, an anti-EFNA4 calicheamicin antibody-drug conjugate, in patients with advanced solid tumors. Int J Cancer. 2019 Oct 1;145(7):1798-1808. doi: 10.1002/ijc.32154. Epub 2019 Feb 23.

*   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: July 11, 2017)		60
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2014)		100
Actual Study Completion Date  ICMJE May 10, 2017
Actual Primary Completion Date May 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
  • Performance Status of 0 or 1
  • Adequate bone marrow, kidney, and liver function
  • Part 2 includes advanced triple negative breast cancer patients.

Exclusion Criteria:

  • Brain metastases requiring steroids
  • Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
  • Active and clinically significant bacterial, fungal or viral infection
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 NCT02078752
Other Study ID Numbers  ICMJE B7521001
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 January 2019

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