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 CancerHormone Receptor (HR) Positive Breast CancerEstrogen receptor (ER) positiveProgesterone receptor (PR) positiveCyclin-dependent kinase (CDK)Human epidermal growth factor receptor 2 (HER2) negativeAdvanced breast cancerMetastatic breast cancer (MBC)Triple negative breast cancer (TNBC)Epithelial ovarian cancer (EOC)Fallopian tube cancerPrimary peritoneal cancer (PPC)CDK4/6 inhibitorEndocrine Therapy (ET)Measurable diseaseLuteinizing Hormone Releasing Hormone (LHRH) AgonistGoserelinLeuprolide acetateBreast NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian EpithelialFallopian Tube NeoplasmsTriple Negative Breast NeoplasmsBreast Neoplasms, MalePF-06873600Endocrine Therapy 1Endocrine Therapy 2Dose 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 Centernot yet accepting patients
    San FranciscoCalifornia94115United States
  • University of California -San Francisconot yet accepting patients
    San FranciscoCalifornia94115United 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