CLINICAL TRIALS PROFILE FOR CAPECITABINE

505(b)(2) Clinical Trials for Capecitabine

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	NCT00215982 ↗	Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer	Completed	Roche Pharma AG	Phase 2	2004-12-01	The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
New Combination	NCT00215982 ↗	Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer	Completed	H. Lee Moffitt Cancer Center and Research Institute	Phase 2	2004-12-01	The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
New Combination	NCT00230399 ↗	Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer	Completed	University of Michigan Cancer Center	Phase 2	2003-06-01	This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
New Combination	NCT00230399 ↗	Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer	Completed	University of Michigan Rogel Cancer Center	Phase 2	2003-06-01	This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.
New Combination	NCT00251329 ↗	Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery	Unknown status	Sanofi	Phase 2	2003-05-01	The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response (PCR). Women with large tumors and or lymph node involvement at the time of initial diagnosis may benefit from receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of tumor involvement before surgery. If chemotherapy given before breast surgery is effective in decreasing the size of the tumor, breast conserving surgery (lumpectomy) may be possible. This new combination may be better tolerated than other commonly used regimens and, to date, appears to be at least as effective.
New Combination	NCT00251329 ↗	Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery	Unknown status	Cancer Research Network	Phase 2	2003-05-01	The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response (PCR). Women with large tumors and or lymph node involvement at the time of initial diagnosis may benefit from receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of tumor involvement before surgery. If chemotherapy given before breast surgery is effective in decreasing the size of the tumor, breast conserving surgery (lumpectomy) may be possible. This new combination may be better tolerated than other commonly used regimens and, to date, appears to be at least as effective.
OTC	NCT00496366 ↗	Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer	Terminated	National Cancer Institute (NCI)	Phase 2	2007-07-23	Subjects with advanced or metastatic (spread to other parts of the body) breast cancer that is HER2/neu-positive will take part in this study. This type of breast cancer has a high amount of a protein called HER2. HER2 is part of a family of receptors found on both cancer and normal cells. This family of receptors is important for cell growth and is found in many tumor types. The purpose of this research study is to compare an approved treatment for breast cancer capecitabine, also called Xeloda®, to the combination of capecitabine plus an experimental drug, lapatinib also known as Tykerb®, for treatment of advanced or metastatic breast cancer that is HER2/neu-positive.Capecitabine is an approved type of chemotherapy used to treat certain cancers including breast cancer. Capecitabine fights cancer by interfering with the ability of cells to divide and tumor growth. Lapatinib (Tykerb®) is considered "investigational", which means the drug has not been approved by the US Food and Drug Administration (FDA) for sale as a prescription or over-the-counter medication. Lapatinib may slow or stop cancer cells from growing by inhibiting the growth of cancer cells. However, this theory has not been proven. The addition of the study drug (lapatinib) to capecitabine may help stop cancer cells as well as or better than capecitabine alone. Other studies have demonstrated activity and tolerability of lapatinib either alone or in combination with capecitabine in the treatment of breast cancer.Subjects will receive capecitabine and lapatinib. A treatment period will be 21 days long. This period is known as a "cycle". All medications will be given by mouth. Subjects will take capecitabine for 2 weeks straight (Day 1-14) followed by a 1 week without capecitabine (Day 15-21). Doses of lapatinib will be taken daily continuously for 21 days (Day 1-Day 21) which means that subjects will still take lapatinib on the week that they do not take capecitabine (Day 15-21). Subjects will continue to receive these medications unless they experience severe, serious and/or excessive side effects, the cancer becomes worse, the subjects wishes to no longer participate or the study doctor feels it is not in the best interest to continue treatment.Tests and procedures such as physical exam, blood tests, CT or MRI, ECG, ECHO and/or MUGA tests will be conducted at one or more of the following time points: before the study starts, before each cycle, every 6 and 12 weeks, and after the last dose of capecitabine/lapatinib treatment.

All Clinical Trials for Capecitabine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003704 ↗	Chemotherapy Plus Radiation Therapy in Treating Patients With Unresectable, Residual, or Recurrent Colorectal Cancer	Completed	National Cancer Institute (NCI)	Phase 1	1999-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs such as capecitabine may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of capecitabine in combination with radiation therapy in treating patients who have unresectable, residual, or recurrent colorectal cancer located in the pelvis.
NCT00003704 ↗	Chemotherapy Plus Radiation Therapy in Treating Patients With Unresectable, Residual, or Recurrent Colorectal Cancer	Completed	Alliance for Clinical Trials in Oncology	Phase 1	1999-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses x-rays to damage tumor cells. Drugs such as capecitabine may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of capecitabine in combination with radiation therapy in treating patients who have unresectable, residual, or recurrent colorectal cancer located in the pelvis.
NCT00003867 ↗	Irinotecan and Capecitabine in Treating Patients With Solid Tumors	Completed	National Cancer Institute (NCI)	Phase 1	1999-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.
NCT00003867 ↗	Irinotecan and Capecitabine in Treating Patients With Solid Tumors	Completed	Albert Einstein College of Medicine of Yeshiva University	Phase 1	1999-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.
NCT00003867 ↗	Irinotecan and Capecitabine in Treating Patients With Solid Tumors	Completed	Montefiore Medical Center	Phase 1	1999-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment.
NCT00003902 ↗	Capecitabine and Vinorelbine in Treating Older Women Who Have Metastatic Breast Cancer With or Without Bone Involvement	Completed	Swiss Group for Clinical Cancer Research	Phase 1/Phase 2	1999-03-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine and vinorelbine and to see how well they work in treating older women with metastatic breast cancer with or without bone involvement.
NCT00004012 ↗	Capecitabine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1998-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.

Clinical Trial Conditions for Capecitabine

Condition Name

Condition Name for Capecitabine
Intervention	Trials
Breast Cancer	238
Colorectal Cancer	171
Gastric Cancer	134
Rectal Cancer	87

Condition MeSH

Condition MeSH for Capecitabine
Intervention	Trials
Breast Neoplasms	451
Colorectal Neoplasms	348
Stomach Neoplasms	224
Adenocarcinoma	211

Clinical Trial Locations for Capecitabine

Trials by Country

Trials by Country for Capecitabine
Location	Trials
China	680
Taiwan	85
Poland	81
Austria	80
Netherlands	76

Trials by US State

Trials by US State for Capecitabine
Location	Trials
California	225
Texas	196
New York	189
Florida	156
Pennsylvania	144

Clinical Trial Progress for Capecitabine

Clinical Trial Phase

Clinical Trial Phase for Capecitabine
Clinical Trial Phase	Trials
Phase 4	24
Phase 3	339
Phase 2/Phase 3	57

Clinical Trial Status

Clinical Trial Status for Capecitabine
Clinical Trial Phase	Trials
Completed	688
Recruiting	346
Unknown status	211

Clinical Trial Sponsors for Capecitabine

Sponsor Name

Sponsor Name for Capecitabine
Sponsor	Trials
National Cancer Institute (NCI)	185
Hoffmann-La Roche	138
Sanofi	62

Sponsor Type

Sponsor Type for Capecitabine
Sponsor	Trials
Other	2017
Industry	945
NIH	188

Capecitabine: Clinical Trials, Market Analysis, and Projections

Introduction to Capecitabine

Capecitabine is an oral chemotherapy medication that has been widely used in the treatment of various types of cancer, including breast, colon, and rectal cancers. Its efficacy and convenience of oral administration have made it a significant player in the oncology landscape.

Clinical Trials Update

Adjuvant Capecitabine in Locally Advanced Nasopharyngeal Carcinoma (LA-NPC)

A recent randomized clinical trial highlighted the benefits of adjuvant capecitabine following concurrent chemoradiotherapy (CCRT) in patients with LA-NPC. The trial, which involved 180 patients, demonstrated that the addition of capecitabine improved failure-free survival (FFS) compared to CCRT alone. With a median follow-up of 58 months, the capecitabine group showed a 3-year FFS rate of 83.3% and a 5-year FFS rate of 78.5%, significantly better than the control group's rates of 72.2% and 65.9%, respectively[1].

Combination Therapy with Tucatinib, Trastuzumab, and Capecitabine

The HER2CLIMB trial evaluated the efficacy of tucatinib in combination with trastuzumab and capecitabine in patients with ERBB2-positive metastatic breast cancer (MBC). The results showed that this combination prolonged median overall survival by 9.1 months and improved progression-free survival compared to the placebo group. This combination was particularly beneficial for patients with brain metastases, reducing the risk of intracranial progression or death by 68%[4].

Market Analysis

Current Market Size and Growth

The global capecitabine market has been experiencing strong growth driven by several factors, including advancements in chemotherapy, the convenience of oral administration, and increasing demand for targeted therapies. As of 2023, the market size was valued at approximately $2.06 billion and is expected to grow to $2.25 billion in 2024 at a compound annual growth rate (CAGR) of 9.4%. By 2028, the market is projected to reach $3.14 billion at a CAGR of 8.7%[3].

Market Trends

• Targeted Therapy Combinations: The market is seeing a rise in the use of capecitabine in combination therapies, such as with tucatinib and trastuzumab, which has shown significant benefits in treating specific types of cancer[4].
• Expanded Use in Adjuvant Settings: Capecitabine is increasingly being used in adjuvant settings, as seen in the trial for LA-NPC, which improves treatment outcomes and patient survival rates[1].
• Biomarker-Driven Treatment: There is a growing focus on biomarker-driven treatments, which enhance the efficacy and safety profiles of capecitabine by tailoring treatment to individual patient characteristics[3].
• Healthcare Infrastructure Development: Improvements in healthcare infrastructure, particularly in developing countries, are expanding access to capecitabine and driving market growth[5].

Regional Market Dynamics

• North America: This region dominates the capecitabine market due to the high prevalence of cancer, robust healthcare systems, and favorable reimbursement policies. The region is expected to continue its dominance in the forecast period[2][5].
• Asia-Pacific and Latin America: These regions are experiencing rapid growth due to increasing cancer incidence rates, expanding healthcare services, and rising healthcare expenditure. Governments and healthcare providers are increasingly adopting capecitabine in clinical practice[5].

Market Projections

Forecast Period

The global capecitabine market is projected to grow at a CAGR of 5% from 2024 to 2033, reaching a market size of $0.7 billion by 2033. This growth is driven by the surge in cancer prevalence, improved healthcare access, and ongoing research and development activities to enhance the efficacy and safety of capecitabine[5].

Key Drivers

• Rising Cancer Prevalence: The increasing number of cancer cases globally, particularly in breast, colon, and rectal cancers, is driving the demand for effective treatment options like capecitabine[5].
• Geriatric Population: The growing geriatric population, which is more susceptible to cancer, is another key driver of the market[5].
• Research and Development: Continuous R&D activities to evaluate new pharmacological applications of capecitabine and improve its safety and efficacy profiles are expected to propel market growth[3][5].

Key Market Players

The capecitabine market is competitive, with several major pharmaceutical companies involved. Key players include Novartis AG, Teva Pharmaceutical Industries Ltd., Sanofi, Pfizer Inc., Bayer AG, Dr. Reddy’s Laboratories Ltd., Merck & Co., Inc., Eli Lilly and Company, F. Hoffmann-La Roche Ltd., and Mylan N.V.[5].

Conclusion

Capecitabine remains a crucial drug in the treatment of various cancers, with ongoing clinical trials and market trends indicating strong growth potential. The drug's efficacy, convenience, and expanding use in combination therapies and adjuvant settings are key factors driving its market.

Key Takeaways

• Clinical Trials: Capecitabine has shown significant benefits in clinical trials, particularly in combination therapies and adjuvant settings.
• Market Growth: The global capecitabine market is expected to grow at a CAGR of 8.7% to 2028 and 5% from 2024 to 2033.
• Regional Dynamics: North America dominates the market, but Asia-Pacific and Latin America are experiencing rapid growth.
• Key Drivers: Rising cancer prevalence, growing geriatric population, and ongoing R&D activities are driving market growth.
• Key Players: Major pharmaceutical companies are actively involved in the capecitabine market.

FAQs

Q1: What is the primary use of capecitabine in cancer treatment? Capecitabine is primarily used in the treatment of breast, colon, and rectal cancers. It is an oral chemotherapy medication that interferes with DNA synthesis, minimizing severe adverse effects on normal cells.

Q2: What are the key findings from the clinical trial on adjuvant capecitabine in LA-NPC? The clinical trial showed that adjuvant capecitabine following concurrent chemoradiotherapy improved failure-free survival in patients with locally advanced nasopharyngeal carcinoma, with a 3-year FFS rate of 83.3% and a 5-year FFS rate of 78.5%[1].

Q3: How does the combination of tucatinib, trastuzumab, and capecitabine benefit patients with MBC? This combination prolongs median overall survival by 9.1 months and improves progression-free survival, particularly in patients with brain metastases, reducing the risk of intracranial progression or death by 68%[4].

Q4: What are the major factors driving the growth of the capecitabine market? The growth is driven by the rising prevalence of cancer, growing geriatric population, and ongoing research and development activities to enhance the efficacy and safety profiles of capecitabine[5].

Q5: Which region dominates the capecitabine market and why? North America dominates the capecitabine market due to the high prevalence of cancer, robust healthcare systems, and favorable reimbursement policies[2][5].

Sources

1. JAMA Oncology: "Adjuvant Capecitabine Following Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma: A Randomized Clinical Trial"[1].
2. Mordor Intelligence: "Capecitabine Market - Size, Share & Industry Analysis"[2].
3. The Business Research Company: "Global Capecitabine Market Report 2024"[3].
4. JAMA Oncology: "Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for ERBB2-Positive Metastatic Breast Cancer: A Randomized Clinical Trial"[4].
5. Allied Market Research: "Capecitabine Market Statistics, Trends | Forecast - 2033"[5].

Last updated: 2025-01-01