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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: PF-05212384 (also known as PKI-587)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00940498

3265K1-1002 (Other Identifier)

B2151001

2009-012379-85 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

78 participants in 1 patient group

1

Experimental group

Description:

PF-05212384 (also known as PKI-587)

Treatment:

Drug: PF-05212384 (also known as PKI-587)