A Study Of PF-06263507 In Patients With Advanced Solid Tumors

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-08

Study Completion Date

2015-06-29

Brief Summary

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To assess the safety and tolerability at increasing dose levels of PF-06263507 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

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Detailed Description

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Conditions

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Neoplasms Carcinoma, Non Small Cell Lung Breast Neoplasms Ovarian Neoplasms

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1

Group Type EXPERIMENTAL

PF-06263507

Intervention Type DRUG

Part 1 - PF-06263507 will be administered intravenously in 21-day cycles in cohorts of 2 or more patients starting at a dose of 0.05 mg/kg. Increases in dose will continue until MTD is determined.

PF-06263507

Intervention Type DRUG

Part 2 - Patients with select tumor types will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.

Interventions

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PF-06263507

Part 1 - PF-06263507 will be administered intravenously in 21-day cycles in cohorts of 2 or more patients starting at a dose of 0.05 mg/kg. Increases in dose will continue until MTD is determined.

Intervention Type DRUG

PF-06263507

Part 2 - Patients with select tumor types will be treated at the MTD or Recommended Phase 2 dose 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 which no standard therapy is available.
* Performance Status of 0 or 1.
* Adequate bone marrow, kidney, liver, and heart function.

Exclusion Criteria

* Brain metastases requiring steroids.
* Major surgery or anti-cancer therapy within 4 weeks of study treatment start.
* Active bacterial, fungal or viral infection.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No