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Study of PF-05212384 (Also Known as PKI-587)Administered Intravenously To Subjects With Solid Tumors (B2151001)

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: July 14, 2009
Last updated: November 8, 2012
Last verified: November 2012
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.

Condition Intervention Phase
Neoplasms Drug: PF-05212384 (also known as PKI-587) Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study Of PF-05212384 (Also Known as PKI-587) Administered As An Intravenous Infusion To Subjects With Solid Tumors

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Assessment of Dose Limiting Toxicities (DLTs), Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Assess safety and tolerability at the MTD [ Time Frame: 2 years ]
  • Assess how the study drug enters the body and what the body does with it [ Time Frame: 2 years ]
  • Assess how well the study drug works [ Time Frame: 2 years ]
  • Assess the effect of the study drug on tumors and other tissues [ Time Frame: 2 years ]

Enrollment: 78
Study Start Date: January 2010
Study Completion Date: October 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PF-05212384 (also known as PKI-587)
Drug: PF-05212384 (also known as PKI-587)
Intravenous dosing once weekly infusion


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00940498

United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10022
Pfizer Investigational Site
New York, New York, United States, 10065
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203-1632
Pfizer Investigational Site
Barcelona, Spain, 08035
United Kingdom
Pfizer Investigational Site
London, England, United Kingdom, SE1 9RT
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT00940498     History of Changes
Other Study ID Numbers: B2151001
Study First Received: July 14, 2009
Last Updated: November 8, 2012

Keywords provided by Pfizer:
Phase 1
Dose Finding
Solid Tumors
PF-05212384 processed this record on June 23, 2017