CLINICAL TRIALS PROFILE FOR LAPATINIB DITOSYLATE

All Clinical Trials for Lapatinib Ditosylate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00085020 ↗	GW572016 and Trastuzumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2/Neu	Completed	GlaxoSmithKline	Phase 1	2004-03-01	RATIONALE: GW572016 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving GW572016 with trastuzumab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of GW572016 when given together with trastuzumab in treating patients with metastatic breast cancer that overexpresses HER2/neu.
NCT00085020 ↗	GW572016 and Trastuzumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2/Neu	Completed	National Cancer Institute (NCI)	Phase 1	2004-03-01	RATIONALE: GW572016 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving GW572016 with trastuzumab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of GW572016 when given together with trastuzumab in treating patients with metastatic breast cancer that overexpresses HER2/neu.
NCT00085020 ↗	GW572016 and Trastuzumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2/Neu	Completed	Jonsson Comprehensive Cancer Center	Phase 1	2004-03-01	RATIONALE: GW572016 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving GW572016 with trastuzumab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of GW572016 when given together with trastuzumab in treating patients with metastatic breast cancer that overexpresses HER2/neu.
NCT00095563 ↗	Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers	Completed	National Cancer Institute (NCI)	Phase 2	2004-09-01	Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent and/or metastatic adenoid cystic cancer or other salivary gland cancers. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
NCT00095667 ↗	Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2004-11-01	Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent or metastatic prostate cancer.
NCT00095940 ↗	Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2004-10-01	This phase I/II trial studies lapatinib to see how well it works in treating young patients with recurrent or refractory central nervous system (CNS) tumors. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
NCT00096447 ↗	Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer	Completed	Gynecologic Oncology Group	Phase 2	2004-11-01	This phase II trial is studying how well lapatinib works in treating patients with recurrent or persistent endometrial cancer. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Clinical Trial Conditions for Lapatinib Ditosylate

Condition Name

Condition Name for Lapatinib Ditosylate
Intervention	Trials
Breast Cancer	21
Stage IV Breast Cancer	11
Stage IIIC Breast Cancer	7
HER2-positive Breast Cancer	7

Condition MeSH

Condition MeSH for Lapatinib Ditosylate
Intervention	Trials
Breast Neoplasms	38
Carcinoma	14
Breast Neoplasms, Male	7
Neoplasms	6

Clinical Trial Locations for Lapatinib Ditosylate

Trials by Country

Trials by Country for Lapatinib Ditosylate
Location	Trials
United States	279
Canada	17
Germany	13
Italy	8
Korea, Republic of	7

Trials by US State

Trials by US State for Lapatinib Ditosylate
Location	Trials
California	19
Ohio	11
Pennsylvania	11
New York	11
Florida	9

Clinical Trial Progress for Lapatinib Ditosylate

Clinical Trial Phase

Clinical Trial Phase for Lapatinib Ditosylate
Clinical Trial Phase	Trials
Phase 3	5
Phase 2/Phase 3	1
Phase 2	32

Clinical Trial Status

Clinical Trial Status for Lapatinib Ditosylate
Clinical Trial Phase	Trials
Completed	46
Terminated	9
Active, not recruiting	7

Clinical Trial Sponsors for Lapatinib Ditosylate

Sponsor Name

Sponsor Name for Lapatinib Ditosylate
Sponsor	Trials
National Cancer Institute (NCI)	48
GlaxoSmithKline	10
European Organisation for Research and Treatment of Cancer - EORTC	5

Sponsor Type

Sponsor Type for Lapatinib Ditosylate
Sponsor	Trials
Other	57
NIH	48
Industry	17

Lapatinib Ditosylate: Clinical Trials, Market Analysis, and Projections

Introduction to Lapatinib Ditosylate

Lapatinib ditosylate, marketed under the brand name Tykerb or Tyverb, is a dual tyrosine kinase inhibitor that targets the epidermal growth factor receptor (EGFR) and ErbB-2 (HER2/neu). Developed by GlaxoSmithKline, this drug has been a significant addition to the treatment arsenal for various types of cancer, particularly breast cancer.

Clinical Trials and Efficacy

Approval and Initial Trials

Lapatinib ditosylate was approved by the US FDA and the European Medicines Agency (EMEA) in 2007 for the treatment of patients with metastatic HER2-positive breast cancer who had previously been treated with other anticancer drugs, including trastuzumab (Herceptin). It is typically used in combination with capecitabine[1].

Combination Therapies

Several clinical trials have explored the efficacy of lapatinib ditosylate in combination with other drugs. For instance, a phase II trial investigated the combination of lapatinib with pazopanib, an angiogenesis inhibitor. While there was no significant difference in the progressive disease rate at week 12, the response rates were higher in the combination treatment arm, suggesting potential benefits for further studies[1].

Another trial combined lapatinib with Avastin (bevacizumab), showing a 34.4% clinical benefit at week 24 and a 62.5% progression-free rate at week 12 in heavily pre-treated patients[1].

Inflammatory Breast Cancer

Lapatinib has also shown promise in treating inflammatory breast cancer, a rare and aggressive form of the disease. In a large prospective clinical trial involving 126 patients refractory to anthracyclines and taxanes, lapatinib demonstrated a response rate approaching 40%, with a median duration of response of 20.9 weeks and overall progression-free survival of 14.6 weeks[1].

Ongoing and Recent Trials

A phase 3 randomized clinical trial compared lapatinib in combination with a taxane versus trastuzumab in combination with a taxane in patients with metastatic breast cancer that overexpresses the HER2 receptor. The primary endpoint was superiority in overall survival, with the trial aiming to assess the efficacy and safety of these combinations[3].

Another phase II trial is studying the side effects and efficacy of lapatinib ditosylate and trastuzumab in treating older patients with HER2-positive breast cancer. This trial aims to determine how well the combination works in treating locally advanced or metastatic breast cancer[4].

Market Analysis

Market Size and Growth

The global lapatinib ditosylate API market has experienced significant growth in recent years. As of 2024, the market size was valued at approximately $13 million and is projected to reach $17 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.4% during the forecast period[5].

Market Segmentation

The market is segmented based on type (min purity less than 98%, min purity 98-99%, min purity more than 99%), application (research, pharmaceutical), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2][5].

Key Players

The main players in the lapatinib ditosylate API market include Hetero, Vannsh Life Sciences, Natco Pharma, Huirui Pharma, Shengda Pharmaceutical, Shijiazhuang Dingmin Pharmaceutical Sciences, ScinoPharm Taiwan, and Shandong Boyuan Pharmaceutical. These companies collectively hold a significant share of the market, with the top three players holding over 29% of the market share[5].

Market Projections

Forecasted Growth

The lapatinib ditosylate API market is expected to continue its upward trend due to increasing demand for targeted cancer therapies. The market dynamics are influenced by factors such as product pricing, national GDP, and the broader market landscape. The forecast indicates robust growth rates throughout the period from 2023 to 2031, driven by the expanding need for effective cancer treatments[2][5].

Regional Outlook

The market analysis includes a detailed examination of regional trends and growth prospects. Asia-Pacific is expected to be a significant contributor to the market growth due to the increasing incidence of cancer and the growing healthcare infrastructure in this region[2].

Safety and Tolerability

Lapatinib ditosylate is generally well-tolerated, with the most common treatment-related adverse events being rash, fatigue, and diarrhea. These side effects are manageable and do not significantly impact the quality of life for most patients[1].

Future Perspectives

New Therapeutic Paradigms

The introduction of targeted cancer therapies like lapatinib ditosylate has opened new avenues for cancer treatment. These therapies aim to halt disease progression, ameliorate symptoms, and improve patient quality of life. The goal is to transform cancers from life-threatening diseases into manageable chronic conditions[1].

Ongoing Research

Ongoing clinical trials and research are focused on optimizing treatment regimens and exploring new combinations of drugs to enhance efficacy and reduce side effects. For instance, the combination of lapatinib with other targeted therapies or immunotherapies is being investigated to improve outcomes for patients with HER2-positive breast cancer[3][4].

Key Takeaways

• Clinical Efficacy: Lapatinib ditosylate has shown significant efficacy in treating HER2-positive breast cancer, particularly in combination with other drugs.
• Market Growth: The global lapatinib ditosylate API market is projected to grow at a CAGR of 4.4% from 2024 to 2030.
• Key Players: Major pharmaceutical companies such as Hetero, Vannsh Life Sciences, and Natco Pharma are key players in the market.
• Safety: The drug is generally well-tolerated with manageable side effects.
• Future Perspectives: Ongoing research aims to optimize treatment regimens and transform cancers into manageable chronic conditions.

FAQs

What is lapatinib ditosylate used for?

Lapatinib ditosylate is used for the treatment of patients with metastatic HER2-positive breast cancer who have previously been treated with other anticancer drugs, including trastuzumab.

What are the common side effects of lapatinib ditosylate?

The most common treatment-related adverse events associated with lapatinib ditosylate are rash, fatigue, and diarrhea.

What is the current market size of the lapatinib ditosylate API market?

As of 2024, the global lapatinib ditosylate API market size is approximately $13 million.

Who are the main players in the lapatinib ditosylate API market?

The main players include Hetero, Vannsh Life Sciences, Natco Pharma, Huirui Pharma, Shengda Pharmaceutical, and others.

What is the projected growth rate of the lapatinib ditosylate API market?

The market is projected to grow at a CAGR of 4.4% from 2024 to 2030.

Sources

1. Clinical Trials Arena: Tykerb - Dual Tyrosine Kinase Inhibitor - Clinical Trials Arena.
2. Market Research Intellect: Lapatinib Ditosylate API Market Size, Scope And Forecast Report.
3. FDA: 022059Orig1s007 | FDA.
4. My Cancer Genome: Clinical Trial: NCT01273610.
5. Valuates Reports: Global Lapatinib Ditosylate API Market Insights, Forecast to 2030.

Last updated: 2025-01-01