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

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NCT02078752

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Massachusetts General Hospital
Boston, Massachusetts, 02114 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT02078752
Pfizer
Completed
A Study Of PF-06647263 In Patients With Advanced Solid Tumors

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A Study Of PF-06647263 In Patients With Advanced Solid Tumors
A First-in-human Phase 1, Dose Escalation, Safety And Pharmacokinetic Study Of Pf-06647263 In Adult Patients With Advanced Solid Tumors
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.
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).
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
  • Neoplasms
  • Triple-Negative Breast Cancer
  • 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.
Experimental: Part 1
Interventions:
  • Drug: PF-06647263
  • Drug: PF-06647263
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2017
May 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02078752
B7521001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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