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Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors

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NCT00940498

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Boston, Massachusetts, 02114 United States
See other locations
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
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

- Pathologic diagnosis of any solid tumor

- Incurable cancer, with disease progression following at least 1 therapy with no
further standard treatment available in the opinion of the investigator.

- At least 1 evaluable lesion per RECIST criteria

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

- Clinically unstable primary or metastatic CNS tumors

- Subjects with known diabetes

- QTc interval greater than 470 ms.

NCT00940498
Pfizer
Completed
Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors

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Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors
A Phase 1 Study Of PF-05212384 (Also Known as PKI-587) Administered As An Intravenous Infusion To Subjects With Solid Tumors
This is a two-part study of a compound called PF-05212384 (also known as PKI-587). The purpose of part 1 is to identify the Maximum Tolerated Dose (MTD) of PF-05212384 using a Continual Reassessment Method (CRM). Part 1 will include subjects with any solid tumor. In Part 2 two cohorts will be enrolled. One cohort will assess safety, tolerability and preliminary efficacy in 20 subjects at the MTD and will include subjects with breast cancer, ovarian cancer, endometrial cancer, colorectal cancer renal cancer or glioblastoma (a type of brain tumor). The other cohort will include 5 to 15 subjects with any type of tumor who consent to provide tumor biopsies while participating in the study.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
Drug: PF-05212384 (also known as PKI-587)
Intravenous dosing once weekly infusion
Experimental: 1
PF-05212384 (also known as PKI-587)
Intervention: Drug: PF-05212384 (also known as PKI-587)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
October 2012
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologic diagnosis of any solid tumor
  • Incurable cancer, with disease progression following at least 1 therapy with no further standard treatment available in the opinion of the investigator.
  • At least 1 evaluable lesion per RECIST criteria

Exclusion Criteria:

  • Clinically unstable primary or metastatic CNS tumors
  • Subjects with known diabetes
  • QTc interval greater than 470 ms.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain,   United Kingdom,   United States
 
 
NCT00940498
B2151001
3265K1-1002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the

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

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