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	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.

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.
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.

Clinical Trial Conditions for palbociclib

Condition Name

Condition Name for palbociclib
Intervention	Trials
Breast Cancer	76
Metastatic Breast Cancer	43
Advanced Breast Cancer	16
Breast Neoplasms	15

Condition MeSH

Condition MeSH for palbociclib
Intervention	Trials
Breast Neoplasms	186
Neoplasms	36
Carcinoma	27
Lymphoma	12

Clinical Trial Locations for palbociclib

Trials by Country

Trials by Country for palbociclib
Location	Trials
Spain	115
Italy	97
Canada	89
Japan	85
China	80

Trials by US State

Trials by US State for palbociclib
Location	Trials
California	73
Texas	63
New York	58
Massachusetts	55
Tennessee	52

Clinical Trial Progress for palbociclib

Clinical Trial Phase

Clinical Trial Phase for palbociclib
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	7
PHASE2	7

Clinical Trial Status

Clinical Trial Status for palbociclib
Clinical Trial Phase	Trials
Recruiting	140
Completed	49
Active, not recruiting	48

Clinical Trial Sponsors for palbociclib

Sponsor Name

Sponsor Name for palbociclib
Sponsor	Trials
Pfizer	127
National Cancer Institute (NCI)	30
AstraZeneca	18

Sponsor Type

Sponsor Type for palbociclib
Sponsor	Trials
Other	342
Industry	267
NIH	31

Palbociclib: Clinical Trials Update, Market Analysis, and Future Projection

Last updated: February 20, 2026

What is the current status of clinical trials for palbociclib?

Palbociclib, marketed as Ibrance by Pfizer, remains under extensive clinical evaluation. As of 2023, over 100 clinical trials involving palbociclib are registered globally. These trials primarily target breast cancer but extend into other cancers, including lung, ovarian, and pancreatic cancers.

Active Clinical Trials (as of 2023):

Trial Phase	Number of Trials	Focus Areas	Major Objectives
Phase I	10	Dose escalation, safety, pharmacokinetics	Establish maximum tolerated dose, initial safety profile
Phase II	45	Efficacy in specific tumor types	Assess response rates, progression-free survival
Phase III	40	Comparative studies against standard care	Confirm efficacy, safety, and overall survival benefit

Major Trials:

• NATALEE (Nab-paclitaxel and Palbociclib in Early Breast Cancer): A phase III trial evaluating palbociclib in early-stage hormone receptor-positive, HER2-negative breast cancer.
• PALOMA Series: Multiple phase III trials comparing palbociclib combined with endocrine therapy versus endocrine therapy alone across advanced breast cancer settings.

What recent clinical data suggest about palbociclib’s efficacy?

Recent data from the PALOMA-3 trial show that adding palbociclib to fulvestrant improves median progression-free survival (PFS) from 4.6 months (control) to 9.5 months (with palbociclib). Overall response rates increased from 16.3% to 42.4% in the combination arm.

In early-phase trials for other cancers:

• Lung cancer studies demonstrate disease stabilization in a subset of patients.
• Ovarian cancer trials report manageable safety profiles with some indications of activity.

How does the market for palbociclib look today?

Market Size and Competition:

• The global market for CDK4/6 inhibitors, including palbociclib, was valued at approximately US$3.2 billion in 2022.
• The market is segmented by indication: breast, lung, ovarian, pancreatic.
• Major competitors include Ribociclib (Kisqali, Novartis) and abemaciclib (Verzenio, Eli Lilly).

Market Share Distribution (2022):

Product	Estimated Market Share	Estimated Revenue (USD millions)
Palbociclib	60%	1,920
Ribociclib	25%	800
Abemaciclib	15%	480

Pricing and Reimbursement:

• Wholesale price per 21-day cycle: approximately US$10,000.
• Reimbursement policies remain favorable in major markets like U.S., EU, Japan, depending on approval for specific indications.

Uptake Drivers:

• FDA and EMA approvals for hormone receptor-positive, HER2-negative advanced breast cancer.
• Positive trial results extending potential indications to earlier disease stages.
• Growing prevalence of breast cancer globally, projected to reach 2.3 million new cases in 2023 (WHO).

What is the future projection for the palbociclib market?

Market Growth Forecast (2023-2028):

• Compound Annual Growth Rate (CAGR): approximately 8.9%.
• Factors influencing growth include approval of new indications, expanded lines of therapy, and combination regimen approvals.

Key Drivers:

• Regulatory approvals for adjuvant and early-stage treatment.
• Pipeline success in other cancers like gastric and pancreatic.
• Pricing stabilization consistent with drug efficacy and safety profiles.

Barriers:

• Patent expirations expected around 2027.
• Rising competition from biosimilars and generics.
• Cost considerations and payer restrictions in emerging markets.

Strategic Outlook:

• Pfizer plans to file new drug applications based on promising data from ongoing trials.
• Expansion into combination therapies may sustain market share.
• Geographic expansion in Asian markets remains a priority.

Key Takeaways

• Clinical trials confirm palbociclib’s efficacy in breast cancer, with ongoing evaluations in other tumor types.
• The global CDK4/6 inhibitor market is mature but growing, with palbociclib holding significant share.
• Future growth depends on regulatory approvals for additional indications and geographic expansion.
• Competition and patent timelines will influence long-term positioning.

FAQs

1. What new indications are under development for palbociclib?

Clinical trials assess its use in non-small cell lung cancer, ovarian cancer, and early-stage breast cancer.

2. Are there biosimilars or generics available for palbociclib?

No biosimilars or generics are currently approved; patent protection extends until 2027.

3. How does palbociclib compare to other CDK4/6 inhibitors?

It has similar efficacy but variations in safety profiles, dosing, and approved indications among competitors.

4. What are the main safety concerns with palbociclib?

Hematologic toxicity, particularly neutropenia, is the most common adverse event.

5. Which markets are projected to show the fastest growth for palbociclib?

Emerging markets in Asia, driven by increasing breast cancer prevalence and expanding healthcare infrastructure.

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References

[1] Pfizer. (2023). Ibrance (palbociclib) Prescribing Information. Retrieved from Pfizer official site.

[2] MarketWatch. (2023). “Global CDK4/6 inhibitors market size and forecast.” Retrieved from MarketWatch database.

[3] World Health Organization. (2023). Cancer statistics 2023. WHO Publications.

[4] ClinicalTrials.gov. (2023). Palbociclib clinical trial registry entries. Retrieved from https://clinicaltrials.gov

[5] Grand View Research. (2022). CDK4/6 Inhibitors Market Size, Share & Trends.