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A Phase 1 Study Of PF-05212384 (Also Known as PKI-587) Administered As An Intravenous Infusion To Subjects With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

A Phase 1 Study Of PF-05212384 (Also Known as PKI-587) Administered As An Intravenous Infusion To Subjects With Solid Tumors


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of Dose Limiting Toxicities (DLTs), Adverse Events (AEs) and Serious Adverse Events (SAEs)

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

B2151001

NCT ID:

NCT00940498

Start Date:

January 2010

Completion Date:

October 2012

Related Keywords:

  • Neoplasms
  • Phase 1
  • Dose Finding
  • Solid Tumors
  • Tumors
  • PF-05212384
  • Neoplasms

Name

Location

Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteBristol, Tennessee  37620