This study is in progress, not accepting new patients

Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies

a study on Breast Cancer Head and Neck Cancer Head and Neck Tumor Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Michelle Melisko (ucsf)
Headshot of Michelle Melisko
Michelle Melisko

Description

Summary

The purpose of this clinical trial is to provide study medicine(s) and learn about their safety. This study is seeking participants who:

  • Have benefited from ongoing study treatment as determined by the study doctor in a Pfizer-sponsored palbociclib Parent Study
  • Must agree to follow the reproductive criteria
  • Are willing and able to comply with all scheduled visits, treatment plans, and other study procedures
  • Can give signed informed consent documents

Participants in this study will continue to receive treatment as they were in the parent study. The time by which participants will take part in this study is retrospective (after completed parent study). We will examine the experiences of people receiving the study medicine(s). This will help us determine if the study medicine(s) are safe. During this time, the participants will be monitored for the safety of the study medicine(s).

Official Title

A TREATMENT PROTOCOL FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED PALBOCICLIB CLINICAL STUDIES

Details

This is an open-label study to provide continued access to treatment for eligible participants who continue to derive clinical benefit as determined by the investigator from study intervention(s) in a Pfizer-sponsored palbociclib clinical study (Parent Study)

Keywords

Breast Cancer, Head and Neck Cancer, Hormone Receptor Positive Advanced Breast Cancer, Squamous Cell Carcinoma of the Head and Neck, Breast Neoplasms, Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, palbociclib, Cetuximab, Fulvestrant, Letrozole

Eligibility

You can join if…

Open to people ages 18 years and up

  • Any participant who is receiving study treatment and deriving clinical benefit as determined by the investigator in a Pfizer-sponsored palbociclib Parent Study
  • Participants must agree to follow the reproductive criteria
  • Participants who are willing and able to comply with all scheduled visits, treatment plans, and other study procedures
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document and protocol

You CAN'T join if...

  • Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study

Locations

  • UCSF Medical Center at Mission Bay
    San Francisco California 94158 United States
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
    Monterrey Nuevo León 64460 Mexico

Lead Scientist at University of California Health

  • Michelle Melisko (ucsf)
    Dr. Michelle E. Melisko is a cancer specialist with expertise in breast cancer treatment and research. She is interested in testing new chemotherapy combinations, biological therapies and immunotherapies for breast cancer, with a particular focus on treatment of cancer that has spread to the brain.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT05226871
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 35 people participating
Last Updated