A Study Of PF-06647263 In Patients With Advanced Solid Tumors

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Neoplasms; Triple-Negative Breast Cancer

Treatments: Drug: PF-06647263

Study type: Interventional

Funder types: Industry

Identifiers

NCT02078752

B7521001

Details and patient eligibility

About

To assess the safety and tolerability at increasing dose levels of PF-06647263 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Full description

The clinical study will include 2 parts. Part 1 will estimate the MTD in dose escalation cohorts in patients with advanced solid tumors for whom no standard therapy is available in order to establish the RP2D. Part 2 will include patients with previously treated metastatic triple negative breast cancer (TNBC).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 advanced triple negative 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
• Active and clinically significant bacterial, fungal or viral infection

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Part 1

Experimental group

Treatment:

Drug: PF-06647263

Drug: PF-06647263