A Study Of PF-06664178 In Patients With Advanced Solid Tumors

NCT ID: NCT02122146

Last Updated: 2018-02-19

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-06-30

Brief Summary

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To assess the safety and tolerability at increasing dose levels of PF-06664178 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

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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PF-06664178

Experimental

Group Type EXPERIMENTAL

PF-06664178

Intervention Type DRUG

Part 1 - PF-06664178 will be administered intravenously every 21 days in cohorts of 2 or more patients starting at a dose of 0.15 mg/kg. Increases in dose will continue until MTD is determined.

PF-06664178

Intervention Type DRUG

Part 2 - patients with select tumor types (Non Small Cell Lung Cancer ovarian cancer, and breast cancer ) will be treated at the MTD selected in Part 1.

Interventions

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PF-06664178

Part 1 - PF-06664178 will be administered intravenously every 21 days in cohorts of 2 or more patients starting at a dose of 0.15 mg/kg. Increases in dose will continue until MTD is determined.

Intervention Type DRUG

PF-06664178

Part 2 - patients with select tumor types (Non Small Cell Lung Cancer ovarian cancer, and breast cancer ) will be treated at the MTD selected in Part 1.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
* Performance Status of 0 or 1
* Adequate bone marrow, kidney and liver function
* Part 2 includes target expressing NSCLC, ovarian or breast cancer patients

Exclusion Criteria

* Brain metastases requiring steroids
* Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
* Active and clinically significant bacterial, fungal, or viral infection
Minimum Eligible Age

18 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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Keck Hospital of USC

Los Angeles, California, United States

Site Status

LAC&USC Medical Center

Los Angeles, California, United States

Site Status

USC/Norris Comprehensive Cancer Center / Investigational Drug Services

Los Angeles, California, United States

Site Status

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Anschutz Cancer Pavilion

Aurora, Colorado, United States

Site Status

University of Colorado Denver CTO (CTRC)

Aurora, Colorado, United States

Site Status

University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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2015-002704-84

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B7401001

Identifier Type: -

Identifier Source: org_study_id

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