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

NCT ID: NCT00940498

Last Updated: 2018-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

PF-05212384 (also known as PKI-587)

Group Type EXPERIMENTAL

PF-05212384 (also known as PKI-587)

Intervention Type DRUG

Intravenous dosing once weekly infusion

Interventions

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PF-05212384 (also known as PKI-587)

Intravenous dosing once weekly infusion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Dana-Farber Cancer Insitute

Boston, Massachusetts, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Sarah Cannon Research Institute, Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

Hospital General Vall D'Hebron

Barcelona, , Spain

Site Status

King's College London

London, England, United Kingdom

Site Status

Countries

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United States Spain United Kingdom

References

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Shapiro GI, Bell-McGuinn KM, Molina JR, Bendell J, Spicer J, Kwak EL, Pandya SS, Millham R, Borzillo G, Pierce KJ, Han L, Houk BE, Gallo JD, Alsina M, Brana I, Tabernero J. First-in-Human Study of PF-05212384 (PKI-587), a Small-Molecule, Intravenous, Dual Inhibitor of PI3K and mTOR in Patients with Advanced Cancer. Clin Cancer Res. 2015 Apr 15;21(8):1888-95. doi: 10.1158/1078-0432.CCR-14-1306. Epub 2015 Feb 4.

Reference Type DERIVED
PMID: 25652454 (View on PubMed)

Related Links

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Other Identifiers

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3265K1-1002

Identifier Type: OTHER

Identifier Source: secondary_id

2009-012379-85

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B2151001

Identifier Type: -

Identifier Source: org_study_id

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