CLINICAL TRIALS PROFILE FOR PALBOCICLIB

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	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.
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	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.

All Clinical Trials for palbociclib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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
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.
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.
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.

Clinical Trial Conditions for palbociclib

Condition Name

Condition Name for palbociclib
Intervention	Trials
Breast Cancer	69
Metastatic Breast Cancer	40
Healthy	14
Breast Neoplasms	13

Condition MeSH

Condition MeSH for palbociclib
Intervention	Trials
Breast Neoplasms	175
Neoplasms	34
Carcinoma	27
Carcinoma, Squamous Cell	11

Clinical Trial Locations for palbociclib

Trials by Country

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−

Trials by Country for palbociclib
Location	Trials
Spain	101
Italy	88
Canada	81
Japan	67
Australia	63

Trials by US State

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−

Trials by US State for palbociclib
Location	Trials
California	68
Texas	58
New York	52
Tennessee	50
Massachusetts	48

Clinical Trial Progress for palbociclib

Clinical Trial Phase

Clinical Trial Phase for palbociclib
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	32
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for palbociclib
Clinical Trial Phase	Trials
Recruiting	125
Completed	48
Active, not recruiting	48

Clinical Trial Sponsors for palbociclib

Sponsor Name

Sponsor Name for palbociclib
Sponsor	Trials
Pfizer	124
National Cancer Institute (NCI)	29
AstraZeneca	17

Sponsor Type

Sponsor Type for palbociclib
Sponsor	Trials
Other	320
Industry	252
NIH	30

Palbociclib: Clinical Trials, Market Analysis, and Projections

Introduction to Palbociclib

Palbociclib, marketed as IBRANCE by Pfizer, is a selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). It has revolutionized the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer since its initial approval in 2015.

Clinical Trials Update

PATINA Trial

The PATINA trial is a significant milestone in the clinical development of palbociclib. This phase III study demonstrated the benefit of adding palbociclib to standard-of-care first-line maintenance therapy for patients with HR+, HER2+ metastatic breast cancer. The trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) when palbociclib was combined with anti-HER2 therapy and endocrine therapy. The median PFS was 44.3 months for patients treated with palbociclib, compared to 29.1 months for those treated without it[1].

PALLAS Trial

The PALLAS trial, although not as positive, provides valuable insights into the use of palbociclib in early breast cancer. This phase III trial compared palbociclib plus standard adjuvant endocrine therapy to standard adjuvant endocrine therapy alone in women and men with HR+, HER2- early invasive breast cancer. The trial was determined unlikely to show a statistically significant improvement in the primary endpoint of invasive disease-free survival (iDFS). However, no unexpected new safety signals were observed, and the study continues to follow patients for long-term outcomes[4].

Vepdegestrant + Palbociclib Phase 1b Study

A recent Phase 1b study evaluated the combination of vepdegestrant, an investigational oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, with palbociclib in heavily pre-treated patients with ER+/HER2- metastatic breast cancer. The study showed promising clinical activity, with a median progression-free survival of 13.9 months at the recommended Phase 3 dose of vepdegestrant. This combination demonstrates potential as an additional treatment option for this patient population[3].

Safety and Tolerability

The safety profile of palbociclib has been consistent across various studies. Common adverse events include hematologic toxicities such as neutropenia and leukopenia, as well as non-hematologic events like fatigue, stomatitis, and diarrhea, which are generally mild to moderate in severity[1][3].

Market Analysis

Global Market Trends

The global palbociclib market is expected to grow steadily, driven by the increasing prevalence of breast cancer and the expanding use of CDK4/6 inhibitors. The global breast cancer drugs market is projected to grow with a CAGR of about 11% during the forecast period, with palbociclib holding a significant portion of this market[5].

Regional Performance

In China, palbociclib entered the market in 2018 and saw rapid sales growth, despite a decline in 2020 due to the COVID-19 pandemic. Sales are expected to recover and grow as the market expands and new indications are approved. Pfizer's decision to reduce the price of palbociclib by about 54% in 2021 is also expected to boost sales volume and revenue[2].

Competitive Landscape

The palbociclib market is dominated by Pfizer, but other players such as Beacon Pharmaceuticals, Incepta Pharmaceuticals, Bluepharma, and NANO DARU are also present. The emergence of new CDK4/6 inhibitors and generic drugs may lead to increased competition and potentially lower prices, making palbociclib more affordable for patients[5].

Market Projections

Growth Forecast

The global palbociclib market is anticipated to expand significantly over the next few years. Asia Pacific is expected to be the fastest-growing region, with a CAGR of 12% during the forecast period. The market growth will be driven by increasing demand for effective breast cancer treatments and the expansion of therapeutic options[5].

Impact of New Indications and Price Adjustments

The approval of new indications for palbociclib, such as its potential use in HR+, HER2+ metastatic breast cancer as shown in the PATINA trial, is expected to increase sales. Additionally, Pfizer's price reduction for palbociclib in China and other regions will make the drug more accessible, further driving market growth[1][2].

Key Takeaways

• Clinical Efficacy: Palbociclib has demonstrated significant clinical benefits in HR+, HER2- and HR+, HER2+ metastatic breast cancer, as evidenced by the PATINA trial.
• Safety Profile: The drug has a consistent safety profile with manageable adverse events.
• Market Growth: The global palbociclib market is expected to grow steadily, driven by increasing demand and expanding therapeutic options.
• Regional Performance: China and other regions are expected to see significant growth, influenced by price adjustments and new indications.
• Competitive Landscape: Pfizer dominates the market, but competition from new CDK4/6 inhibitors and generic drugs is anticipated.

FAQs

What is palbociclib used for?

Palbociclib is used to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, and it is being investigated for use in HR+, HER2+ metastatic breast cancer.

What are the common side effects of palbociclib?

Common side effects include hematologic toxicities such as neutropenia and leukopenia, as well as non-hematologic events like fatigue, stomatitis, and diarrhea.

How has the COVID-19 pandemic affected palbociclib sales in China?

The COVID-19 pandemic led to a decline in palbociclib sales in China in 2020, but sales are expected to recover as the market expands and hospital operations resume.

What is the current market trend for palbociclib?

The global palbociclib market is expected to grow steadily, with Asia Pacific being the fastest-growing region, driven by increasing demand and expanding therapeutic options.

Who are the key players in the palbociclib market?

Pfizer is the dominant player, but other companies such as Beacon Pharmaceuticals, Incepta Pharmaceuticals, Bluepharma, and NANO DARU are also present in the market.

Sources

1. News-Medical.Net: "PATINA trial demonstrates benefit of palbociclib in HR+ HER2+ metastatic breast cancer" - December 12, 2024.
2. BusinessWire: "Investigation Report on China's Palbociclib Markets, 2021-2025" - March 7, 2022.
3. Pfizer: "Arvinas and Pfizer Announce Updated Clinical Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®)" - May 16, 2024.
4. Pfizer: "Pfizer Provides Update on Phase 3 PALLAS Trial of IBRANCE® (palbociclib) Plus Endocrine Therapy in HR+, HER2- Early Breast Cancer" - May 29, 2020.
5. Reports and Data: "Palbociclib Market - Reports and Data" - Accessed January 1, 2025.