Continuing treatment for patients benefiting from palbociclib
A TREATMENT PROTOCOL FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED PALBOCICLIB CLINICAL STUDIES
PHASE2 · Pfizer · NCT05226871
This study is testing if continuing treatment with palbociclib and other medications can help people with advanced breast cancer and head and neck cancer who have already benefited from it.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer (industry) |
| Locations | 22 sites (San Francisco, California and 21 other locations) |
| Trial ID | NCT05226871 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to provide ongoing treatment with palbociclib and other medications for participants who have shown clinical benefit in a previous Pfizer-sponsored study. It is an open-label, Phase 2 trial where eligible patients will continue their treatment regimen while being monitored for safety and efficacy. Participants must comply with scheduled visits and treatment plans, and their experiences will be evaluated to ensure the safety of the study medications. The study focuses on patients with advanced breast cancer and head and neck cancer.
Who should consider this trial
Good fit: Ideal candidates are patients who have benefited from previous treatment with palbociclib in a Pfizer-sponsored study.
Not a fit: Patients who are not deriving clinical benefit from the parent study or have medical reasons preventing their inclusion will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide continued access to effective treatments for patients with advanced cancers.
How similar studies have performed: Other studies involving palbociclib have shown promising results, indicating that this approach is built on previously successful methodologies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study
Where this trial is running
San Francisco, California and 21 other locations
- UCSF Medical Center at Mission Bay — San Francisco, California, United States (RECRUITING)
- The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (RECRUITING)
- Beijing Cancer Hospital — Beijing, Beijing, China (RECRUITING)
- Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
- Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (RECRUITING)
- Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
- Hubei Cancer Hospital — Wuhan, Hubei, China (RECRUITING)
- The First hospital of Jilin University — Changchun, Jilin, China (RECRUITING)
- The First Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (RECRUITING)
- Cancer Hospital Chinese Academy of Medical Science — Beijing, China (RECRUITING)
- National Cancer Center — Goyang-si, Gyeonggi-do, Korea, Republic of (RECRUITING)
- Samsung Medical Center — Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of (RECRUITING)
- Seoul National University Hospital — Seoul, Korea, Republic of (RECRUITING)
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez" — Monterrey, Nuevo LEÓN, Mexico (RECRUITING)
- National Cheng Kung University Hospital — Tainan, Taiwan (RECRUITING)
- Mackay Memorial Hospital — Taipei, Taiwan (RECRUITING)
- Faculty of Medicine, Ramathibodi Hospital, Mahidol University — Ratchathewi, Bangkok, Thailand (RECRUITING)
- Department of Medicine, Faculty of Medicine Siriraj Hospital — Bangkok, Thailand (RECRUITING)
- Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" — Chernivtsi, Chernivetska Oblast, Ukraine (RECRUITING)
- Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council — Dnipro, Ukraine (RECRUITING)
- Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council — Ivano-Frankivsk, Ukraine (ACTIVE_NOT_RECRUITING)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Head and Neck Cancer, Hormone Receptor Positive Advanced Breast Cancer, Squamous Cell Carcinoma of the Head and Neck