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

NCT03284723 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2024-09-03

Study results available
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Summary

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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

PF-06804103

Dose Escalation Part - 1A Dose Expansion Part - 2A

DRUG

PF-06804103 + Palbociclib +Letrozole

Dose Escalation - Part 1B Dose Expansion - Part 2B

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2021-08-31
Completion
2021-08-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Italy
  • Russia
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03284723 on ClinicalTrials.gov