A Study Of PF-06263507 In Patients With Advanced Solid Tumors

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NCT01891669

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Study Location
Brigham and Women's Hospital
Boston, Massachusetts, 02115, 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, Non Small Cell Lung Carcinoma, Breast Neoplasms, Ovarian 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 solid tumor that is advanced/metastatic and resistant to standard therapy or for which no standard therapy is available.

- Performance Status of 0 or 1.

- Adequate bone marrow, kidney, liver, and heart function.

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


- Brain metastases requiring steroids.


- Major surgery or anti-cancer therapy within 4 weeks of study treatment start.


- Active bacterial, fungal or viral infection.

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Neoplasms, Non Small Cell Lung Carcinoma, Breast Neoplasms, Ovarian NeoplasmsA Study Of PF-06263507 In Patients With Advanced Solid Tumors
NCT01891669
  1. Boston, Massachusetts
  2. Boston, Massachusetts
  3. Detroit, Michigan
  4. Philadelphia, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of PF-06263507 In Patients With Advanced Solid Tumors
Official Title  ICMJE A PHASE 1, DOSE ESCALATION STUDY OF PF-06263507 IN PATIENTS WITH ADVANCED SOLID TUMORS
Brief Summary To assess the safety and tolerability at increasing dose levels of PF-06263507 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neoplasms
  • Carcinoma, Non Small Cell Lung
  • Breast Neoplasms
  • Ovarian Neoplasms
Intervention  ICMJE
  • Drug: PF-06263507
    Part 1 - PF-06263507 will be administered intravenously in 21-day cycles in cohorts of 2 or more patients starting at a dose of 0.05 mg/kg. Increases in dose will continue until MTD is determined.
  • Drug: PF-06263507
    Part 2 - Patients with select tumor types will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
Study Arms  ICMJE Experimental: Part 1
Interventions:
  • Drug: PF-06263507
  • Drug: PF-06263507
Publications * Shapiro GI, Vaishampayan UN, LoRusso P, Barton J, Hua S, Reich SD, Shazer R, Taylor CT, Xuan D, Borghaei H. First-in-human trial of an anti-5T4 antibody-monomethylauristatin conjugate, PF-06263507, in patients with advanced solid tumors. Invest New Drugs. 2017 Jun;35(3):315-323. doi: 10.1007/s10637-016-0419-7. Epub 2017 Jan 9.

*   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 16, 2015)		26
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2013)		75
Actual Study Completion Date  ICMJE June 29, 2015
Actual Primary Completion Date June 29, 2015   (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 which no standard therapy is available.
  • Performance Status of 0 or 1.
  • Adequate bone marrow, kidney, liver, and heart function.

Exclusion Criteria:

  • Brain metastases requiring steroids.
  • Major surgery or anti-cancer therapy within 4 weeks of study treatment start.
  • Active 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 NCT01891669
Other Study ID Numbers  ICMJE B4481001
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 December 2018

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