A Safety, Pharmacokinetic, Pharmacodynamic and Anti-Tumor Study of PF-06873600 as a Single Agent and in Combination With Endocrine Therapy

a study on Breast Cancer Fallopian Tube Cancer HER2 Ovarian Cancer Peritoneal Cancer

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06873600 administered as a single agent and then in combination with endocrine therapy. The study contains two parts, a Part 1 single agent dose escalation and combination endocrine therapy dose finding component and a Part 2 dose expansion as both a single agent and in combination with endocrine therapy.

Official Title

PHASE 1/2A DOSE ESCALATION AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMICS AND ANTI-TUMOR ACTIVITY OF PF-06873600 AS A SINGLE AGENT AND IN COMBINATION WITH ENDOCRINE THERAPY

Details

This is a Phase 1/2a, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of PF-06873600 administered as a single agent in sequential dose levels and then in combination with endocrine therapy. In Part 1A, successive cohorts of patients will receive escalating doses of PF-06873600 and then in dose finding (Part 1B) with PF-06873600 in combination with endocrine therapy (ET). This study contains 2 parts, dose escalation with single agent (Part 1A) and then dose finding with PF-06873600 in combination with endocrine therapy (Part 1B) followed by dose expansion arms as a single agent and PF-06873600 in combination with endocrine therapy (Part 2).

Keywords

HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer Hormone Receptor (HR) Positive Breast Cancer Estrogen receptor (ER) positive Progesterone receptor (PR) positive Cyclin-dependent kinase (CDK) Human epidermal growth factor receptor 2 (HER2) negative Advanced breast cancer Metastatic breast cancer (MBC) Triple negative breast cancer (TNBC) Epithelial ovarian cancer (EOC) Fallopian tube cancer Primary peritoneal cancer (PPC) CDK4/6 inhibitor Endocrine Therapy (ET) Measurable disease Luteinizing Hormone Releasing Hormone (LHRH) Agonist Goserelin Leuprolide acetate Breast Neoplasms Ovarian Neoplasms Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms Triple Negative Breast Neoplasms Breast Neoplasms, Male Endocrine Therapy 1 Endocrine Therapy 2 Dose Escalation

Eligibility

You can join if…

Open to people ages 18 years and up

  • Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer

• Prior combined CDK 4/6 inhibitor and endocrine therapy and 1 or 2 prior lines of chemotherapy

  • Have a diagnosis of metastatic triple negative breast cancer (TNBC)

• Up to 1-2 prior lines of chemotherapy

  • Have a diagnosis of advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC)

• Up to 2-3 prior lines of therapy

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  • Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1)
  • Measurable disease as defined by RECIST 1.1 is required (Part 2)

You CAN'T join if...

  • Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases
  • Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
  • Major surgery or radiation within 4 weeks prior to study entry
  • Last anti-cancer treatment within 2 weeks prior to study entry
  • Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
  • Pregnant or breastfeeding female patients
  • Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastro intestinal function or GI disease

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94115 United States
  • University of California -San Francisco accepting new patients
    San Francisco California 94115 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
To obtain contact information for a study center near you, click here.
ID
NCT03519178
Phase
Phase 2
Study Type
Interventional
Last Updated