You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

CLINICAL TRIALS PROFILE FOR PALBOCICLIB


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for palbociclib

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT01522989 ↗ PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies Unknown status Pfizer Phase 1 2011-12-01 This study is for patients with advanced solid tumor malignancies (cancer that has spread to other parts of the body). The purpose of this study is to test the safety and effectiveness of a new combination of drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus decreasing the tumors in the body. PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in colorectal cancer. It is given as a pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved for and used as chemotherapy for several cancers.
New Combination NCT01522989 ↗ PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies Unknown status Georgetown University Phase 1 2011-12-01 This study is for patients with advanced solid tumor malignancies (cancer that has spread to other parts of the body). The purpose of this study is to test the safety and effectiveness of a new combination of drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus decreasing the tumors in the body. PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in colorectal cancer. It is given as a pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved for and used as chemotherapy for several cancers.
New Combination NCT04012918 ↗ Capecitabine in Combination With Aromatase Inhibitor Versus Aromatase Inhibitors, in Hormonal Receptor Positive Recurrent or Metastatic Breast Cancer Patients, Randomized Controlled Study Unknown status Ain Shams University Phase 2 2018-08-30 Women with recurrent or metastatic breast cancer who are hormone receptor positive are candidates for first line hormonal therapy including aromatase inhibitors. In the past few years new combination therapies became available as fulvastrant or palbociclib with letrezole; increasing the progression free survival (PFS). A retrospective study showed that combination of capecitabine with aromatase inhibitors increase PFS as 1st and 2nd line line treatment another prospective study showed the same results. The aim of our study is confirm such data by a randomized controlled trial.
New Combination NCT05721443 ↗ Cetuximab Plus Dalpicilib in Patients With HPV Negative, PD-1 Resistant R/M HNSCC Recruiting Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Phase 2 2023-04-01 This study is the first clinical study in PD-1 resistant patients with head and neck squamous cell carcinoma with drugs targeting EGFR signaling pathway combined with CDK4/6 inhibitors, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for palbociclib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00141297 ↗ A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer Completed Pfizer Phase 1 2004-09-01 PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.
NCT00420056 ↗ An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma. Completed Pfizer Phase 1 2007-05-01 This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is also known as a "PET scan". This study will assess the safety of using PD-0332991 in patients with mantle cell lymphoma.
NCT00555906 ↗ An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma. Completed Pfizer Phase 2 2008-01-01 This is a Phase 1/2 study evaluating the safety and anti-tumor activity of PD 0332991 in combination with Velcade® [bortezomib] and dexamethasone in patients who have received at least one previous treatment for multiple myeloma.
NCT00721409 ↗ Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer Completed Pfizer Phase 2 2008-09-15 The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer
NCT01037790 ↗ Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer Completed Abramson Cancer Center of the University of Pennsylvania Phase 2 2009-10-01 RATIONALE: PD 0332991 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects and how well PD 0332991 works in treating patients with refractory solid tumors.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for palbociclib

Condition Name

Condition Name for palbociclib
Intervention Trials
Breast Cancer 68
Metastatic Breast Cancer 38
Healthy 14
Breast Neoplasms 13
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for palbociclib
Intervention Trials
Breast Neoplasms 170
Neoplasms 32
Carcinoma 25
Carcinoma, Squamous Cell 11
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for palbociclib

Trials by Country

Trials by Country for palbociclib
Location Trials
Spain 94
Italy 79
Canada 79
Japan 67
Australia 58
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for palbociclib
Location Trials
California 66
Texas 55
New York 51
Tennessee 48
Massachusetts 47
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for palbociclib

Clinical Trial Phase

Clinical Trial Phase for palbociclib
Clinical Trial Phase Trials
Phase 4 6
Phase 3 31
Phase 2/Phase 3 3
[disabled in preview] 167
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for palbociclib
Clinical Trial Phase Trials
Recruiting 116
Active, not recruiting 48
Completed 48
[disabled in preview] 56
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for palbociclib

Sponsor Name

Sponsor Name for palbociclib
Sponsor Trials
Pfizer 123
National Cancer Institute (NCI) 27
AstraZeneca 16
[disabled in preview] 19
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for palbociclib
Sponsor Trials
Other 313
Industry 247
NIH 28
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.