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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.
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
History of Changes

July 14, 2009
November 8, 2012
January 2010
August 2011   (final data collection date for primary outcome measure)
Assessment of Dose Limiting Toxicities (DLTs), Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00940498 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: Yes ]
  • Assess how well the study drug works [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Spain,   United Kingdom
 
NCT00940498
B2151001, 3265K1-1002
No
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