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Last Updated: December 1, 2021

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CLINICAL TRIALS PROFILE FOR PALBOCICLIB

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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.
>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 VelcadeĀ® [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
NCT01111188 ↗ Trial of PD 0332991 Plus Bortezomib in Patients With Relapsed Mantle Cell Lymphoma Terminated Millennium Pharmaceuticals, Inc. Phase 1 2010-08-23 Mantle cell lymphoma (MCL) is characterized by cell cycle dysregulation. PD 0332991 is a cyclin-dependent kinase 4 and 6 inhibitor capable of inhibiting cell cycling of MCL. A phase I study has demonstrated the safety and anti-lymphoma activity of PD 0332991. Bortezomib is a first generation proteasome inhibitor approved for treatment of patients with recurrent MCL. Preclinical data suggests that PD 0332991 and bortezomib may act synergistically in MCL. PD 0332991 will be administered continuously for 12 days followed by a 9 day period without treatment. Bortezomib will be administered by intravenous bolus on days 8, 11, 15, and 18 of each cycle. One cycle is defined as three weeks. A maximum of ten cycles will be administered.
NCT01111188 ↗ Trial of PD 0332991 Plus Bortezomib in Patients With Relapsed Mantle Cell Lymphoma Terminated Pfizer Phase 1 2010-08-23 Mantle cell lymphoma (MCL) is characterized by cell cycle dysregulation. PD 0332991 is a cyclin-dependent kinase 4 and 6 inhibitor capable of inhibiting cell cycling of MCL. A phase I study has demonstrated the safety and anti-lymphoma activity of PD 0332991. Bortezomib is a first generation proteasome inhibitor approved for treatment of patients with recurrent MCL. Preclinical data suggests that PD 0332991 and bortezomib may act synergistically in MCL. PD 0332991 will be administered continuously for 12 days followed by a 9 day period without treatment. Bortezomib will be administered by intravenous bolus on days 8, 11, 15, and 18 of each cycle. One cycle is defined as three weeks. A maximum of ten cycles will be administered.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for palbociclib

Condition Name

Condition Name for palbociclib
Intervention Trials
Breast Cancer 52
Metastatic Breast Cancer 29
Healthy 14
Breast Neoplasms 13
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Condition MeSH

Condition MeSH for palbociclib
Intervention Trials
Breast Neoplasms 142
Neoplasms 24
Carcinoma 18
Lymphoma 9
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Clinical Trial Locations for palbociclib

Trials by Country

Trials by Country for palbociclib
Location Trials
United States 994
Spain 86
Canada 79
Italy 72
Japan 63
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Trials by US State

Trials by US State for palbociclib
Location Trials
California 58
Texas 49
New York 46
Tennessee 43
Massachusetts 43
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Clinical Trial Progress for palbociclib

Clinical Trial Phase

Clinical Trial Phase for palbociclib
Clinical Trial Phase Trials
Phase 4 5
Phase 3 23
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for palbociclib
Clinical Trial Phase Trials
Recruiting 101
Completed 46
Active, not recruiting 43
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Clinical Trial Sponsors for palbociclib

Sponsor Name

Sponsor Name for palbociclib
Sponsor Trials
Pfizer 114
National Cancer Institute (NCI) 21
AstraZeneca 15
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Sponsor Type

Sponsor Type for palbociclib
Sponsor Trials
Other 276
Industry 203
NIH 22
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