PF-06804103 Dose Escalation in HER2 Positive and Negative (Negative Only in Part 2) Solid Tumors

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Breast Neoplasms

Treatments: Drug: PF-06804103 + Palbociclib +Letrozole; Drug: PF-06804103

Study type: Interventional

Funder types: Industry

Identifiers

NCT03284723

C0541001

2017-002538-22 (EudraCT Number)

Details and patient eligibility

About

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive and negative breast and gastric cancer (HER2 positive only and gastric were studied in Part 1A only). The study will expand to look at selected doses in patients with HER2 positive and negative breast cancer.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available (Part 1A only)
• HER2 positive and negative breast cancer (Part 2A)
• HER2 negative breast cancer (Part 1B & Part 2B)
• Performance status of 0 or 1
• Adequate bone marrow, kidney and liver function

Exclusion criteria

• Known CNS disease including, but not limited to, metastases
• History of exposure to certain cumulative doses of anthracyclines
• Grade 3 or higher hypersensitivity reaction to prior receipt of any antibody therapy
• Active and clinically significant bacterial, fungal, or viral infection
• Abnormal cardiac function defined by a LVEF <50% by ECHO or MUGA
• Patients with previous history or active interstitial lung disease or pulmonary fibrosis, or a history of other clinically significant lung diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

PF-06804103

Experimental group

Description:

Study Treatment

Treatment:

Drug: PF-06804103

PF-06804103+Combination Regimen

Experimental group

Description:

Study Treatment

Treatment:

Drug: PF-06804103 + Palbociclib +Letrozole