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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00940498
First received: July 14, 2009
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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: Endpoint Classification: Safety Study
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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess safety and tolerability at the MTD [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Assess how the study drug enters the body and what the body does with it [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Assess how well the study drug works [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Assess the effect of the study drug on tumors and other tissues [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00940498

Locations
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
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
Spain
Pfizer Investigational Site
Barcelona, Spain, 08035
United Kingdom
Pfizer Investigational Site
London, England, United Kingdom, SE1 9RT
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00940498     History of Changes
Other Study ID Numbers: B2151001, 3265K1-1002
Study First Received: July 14, 2009
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
Dose Finding
Solid Tumors
Tumors
PF-05212384

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 31, 2014