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

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ClinicalTrials.gov Identifier: NCT00940498
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : November 12, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasms Drug: PF-05212384 (also known as PKI-587) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Primary Completion Date : August 2011
Study Completion Date : October 2012

Arm Intervention/treatment
Experimental: 1
PF-05212384 (also known as PKI-587)
Drug: PF-05212384 (also known as PKI-587)
Intravenous dosing once weekly infusion

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

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

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00940498     History of Changes
Other Study ID Numbers: B2151001
First Posted: July 16, 2009    Key Record Dates
Last Update Posted: November 12, 2012
Last Verified: November 2012

Keywords provided by Pfizer:
Phase 1
Dose Finding
Solid Tumors