CLINICAL TRIALS PROFILE FOR XELODA

505(b)(2) Clinical Trials for Xeloda

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	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.
OTC	NCT00496366 ↗	Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer	Terminated	Rutgers Cancer Institute of New Jersey	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.
OTC	NCT00496366 ↗	Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer	Terminated	Rutgers, The State University of New Jersey	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 Xeloda

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.
NCT00004183 ↗	Capecitabine in Treating Patients With Malignant Mesothelioma	Completed	National Cancer Institute (NCI)	Phase 2	2000-11-01	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 malignant mesothelioma.
NCT00004183 ↗	Capecitabine in Treating Patients With Malignant Mesothelioma	Completed	Alliance for Clinical Trials in Oncology	Phase 2	2000-11-01	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 malignant mesothelioma.
NCT00006108 ↗	Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	1999-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine, paclitaxel, and trastuzumab in treating patients who have metastatic breast cancer.
NCT00006108 ↗	Capecitabine, Paclitaxel, and Trastuzumab in Treating Patients With Metastatic Breast Cancer	Completed	UNC Lineberger Comprehensive Cancer Center	Phase 1/Phase 2	1999-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining capecitabine, paclitaxel, and trastuzumab in treating patients who have metastatic breast cancer.
NCT00008034 ↗	Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 1	2000-02-01	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 and shrink tumors so they can be removed during surgery. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy before surgery in treating women who have locally advanced, inflammatory, or large surgically removable breast cancer.

Clinical Trial Conditions for Xeloda

Condition Name

Condition Name for Xeloda
Intervention	Trials
Breast Cancer	103
Colorectal Cancer	65
Gastric Cancer	43
Pancreatic Cancer	36

Condition MeSH

Condition MeSH for Xeloda
Intervention	Trials
Breast Neoplasms	175
Colorectal Neoplasms	128
Rectal Neoplasms	83
Stomach Neoplasms	74

Clinical Trial Locations for Xeloda

Trials by Country

Trials by Country for Xeloda
Location	Trials
Spain	138
China	132
Canada	107
Italy	82
Brazil	64

Trials by US State

Trials by US State for Xeloda
Location	Trials
Texas	91
California	88
New York	72
Florida	70
Pennsylvania	59

Clinical Trial Progress for Xeloda

Clinical Trial Phase

Clinical Trial Phase for Xeloda
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	8

Clinical Trial Status

Clinical Trial Status for Xeloda
Clinical Trial Phase	Trials
Completed	288
Terminated	90
Recruiting	87

Clinical Trial Sponsors for Xeloda

Sponsor Name

Sponsor Name for Xeloda
Sponsor	Trials
Hoffmann-La Roche	96
National Cancer Institute (NCI)	93
M.D. Anderson Cancer Center	29

Sponsor Type

Sponsor Type for Xeloda
Sponsor	Trials
Other	687
Industry	347
NIH	94

Clinical Trials Update, Market Analysis, and Projection for XELODA (Capecitabine)

Last updated: November 3, 2025

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Introduction

XELODA, branded as Capecitabine, is an oral chemotherapeutic agent developed by Roche that is primarily used in the treatment of various cancers, including colorectal, breast, gastric, and pancreatic cancers. As an essential component of oncology pharmacotherapy, XELODA’s clinical development, market dynamics, and future projections are vital for stakeholders, including pharmaceutical companies, investors, healthcare providers, and policymakers. This report delivers a comprehensive update on ongoing and upcoming clinical trials, examines market trends, and presents a strategic outlook for XELODA’s future.

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Clinical Trials Update

Current Clinical Landscape

As of 2023, XELODA remains actively involved in multiple clinical trials, underscoring its vital role in ongoing oncology research. ClinicalTrials.gov lists approximately 15 active studies exploring its safety, efficacy, and combinatorial regimens across various cancer types. Notably:

• Combination Therapies: Several trials are assessing XELODA combined with immune checkpoint inhibitors (e.g., pembrolizumab and nivolumab). These studies intend to evaluate synergistic effects in advanced or metastatic settings for colorectal and gastric cancers. For instance, a Phase II study (NCT04564820) is investigating XELODA with pembrolizumab in metastatic colorectal carcinoma refractory to standard therapy.

• Adjuvant Settings: Trials focusing on XELODA’s use as an adjuvant or maintenance therapy, especially in metastatic breast and gastric cancers, are ongoing. A Phase III trial (NCT04323788) is examining XELODA versus placebo as maintenance therapy in metastatic gastric cancer.

• Novel Formulations and Dosing: Research into novel delivery systems aims to optimize pharmacokinetics and reduce toxicity. For example, studies are exploring nanoparticle-linked formulations to improve tumor targeting.

Pipeline and Regulatory Milestones

While no new formulations have received recent regulatory approvals, Roche persists in submitting supplemental data to regulatory agencies for expanded indications and optimized dosing regimens. Recently, the European Medicines Agency (EMA) approved XELODA in combination with bevacizumab for metastatic colorectal cancer, solidifying its backbone role in combination regimens.

Emerging Research

Emerging studies suggest potential in combining XELODA with targeted therapies and immunotherapies, capitalizing on its mechanism that activates tumor-specific cytotoxicity via thymidine phosphorylase activity.

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Market Analysis

Global Market Overview

The global capecitabine market, anchored by XELODA, was valued at approximately USD 950 million in 2022. The oncology drug segment's growth is driven by rising cancer incidence, expanding therapeutic indications, and shifts toward oral chemotherapy options.

Regional Market Dynamics

• North America: The largest market, fueled by advanced healthcare infrastructure, high cancer prevalence (e.g., colorectal and breast), and ongoing clinical applications of XELODA in combination treatments. The U.S. accounts for over 45% of the global market share.

• Europe: Growing adoption of oral chemotherapies, with increased approval for combination regimens, supports steady growth. Notably, the EMA’s recent approval of XELODA plus bevacizumab in colorectal cancer sustains demand.

• Asia-Pacific: Fastest-growing region, driven by increasing cancer burdens in China and India, expanding healthcare access, and local manufacturing capabilities.

Market Drivers and Challenges

Drivers:

• Broadening indications and combination therapy approvals.
• Preference for oral chemotherapeutics, improving patient compliance.
• Ongoing clinical research promising new indications.

Challenges:

• Competition from alternatives like S-1, capecitabine’s chemical cousin, with similar efficacy.
• Patent expirations and generic penetration reducing revenue potential.
• Side effect profile, including hand-foot syndrome and diarrhea, posing adherence challenges.

Competitive Landscape

Major competitors include S-1 (an oral fluoropyrimidine used in Asia), U.S.-based generic capecitabine producers, and emerging targeted therapies. Roche maintains a dominant market position due to its early market entry and established clinical record.

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Market Projection and Future Outlook

Forecast Overview (2023-2030)

The capecitabine market is projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 6.2%. By 2030, the market value is expected to surpass USD 1.6 billion, driven by:

• Expanded indications: Clinical trials might lead to approvals for additional cancer types, such as pancreatic or lung cancers.
• Combination therapies: The increasing success of combinatorial regimens with immune checkpoint inhibitors or targeted therapies could amplify market share.
• Regulatory approvals: Streamlined approval processes and expanded indication submissions could boost adoption.

Potential Growth Opportunities

• Personalized oncology: Biomarker-driven approaches could optimize XELODA utilization, leading to tailored treatment regimens.
• Oral chemotherapy adherence: Innovations that improve tolerability and reduce side effects can increase patient adherence and expand market uptake.
• Emerging markets: Rapid economic growth and healthcare infrastructure development in Asia and Latin America present vast opportunities.

Risks to Market Growth

• Development of novel agents offering superior efficacy or safety profiles.
• Patent cliffs leading to price erosion due to generic competition.
• Regulatory hurdles, especially in emerging markets, could impede rapid adoption.

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Strategic Recommendations

• Investment in Clinical Research: Prioritize trials that investigate innovative combination regimens, emphasizing immunotherapy synergy.
• Market Expansion: Engage regulatory authorities proactively to secure approvals for broader indications, especially in Asian markets.
• Patient-Centric Formulations: Invest in developing reduced-toxicity formulations to improve tolerability.
• Competitive Positioning: Leverage Roche’s established reputation and clinical data to differentiate XELODA within the oral chemotherapy landscape.

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Key Takeaways

• XELODA remains a cornerstone in oral chemotherapy, with ongoing clinical trials exploring its potential in combination with immunotherapies, aiming to enhance efficacy.

• The global capecitabine market is poised for steady growth, driven by expanding indications, increased cancer incidence, and patient preference for oral regimens.

• Strategic investments in combination therapy trials and formulation improvements can secure competitive advantage amid declining patent protections and emerging generic competition.

• Regulatory expansion, especially in Asia and Latin America, offers significant growth avenues, contingent on demonstrating efficacy and safety in diverse populations.

• Continuous surveillance of clinical developments and regulatory trends is vital for stakeholders seeking to optimize XELODA’s commercial and therapeutic footprint.

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FAQs

1. What are the key indications for XELODA?
XELODA is primarily indicated for metastatic colorectal, breast, gastric, and pancreatic cancers, often in combination with other agents or as a maintenance therapy.

2. Are there ongoing trials exploring new uses for XELODA?
Yes. Current clinical trials are investigating XELODA’s efficacy in combination with immunotherapy agents and in different cancer settings, potentially broadening its therapeutic indications.

3. How does XELODA compare with other oral chemotherapies?
XELODA offers convenience as an oral agent with a well-established efficacy profile. However, competition from drugs like S-1 and emerging targeted agents challenge its market share, emphasizing the need for combination therapies and improved formulations.

4. What are the main challenges facing XELODA’s market growth?
Patent expirations leading to generics, competition from similar drugs, side effect management, and regulatory delays are primary hurdles.

5. What is the outlook for XELODA in emerging markets?
The outlook remains positive, with increasing cancer prevalence and healthcare expansion presenting opportunities. Strategic regulatory engagement and affordability initiatives can accelerate penetration.

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References

[1] ClinicalTrials.gov. “Capecitabine Clinical Trials.” Accessed 2023.
[2] MarketWatch. “Capecitabine Market Size and Forecast.” 2023.
[3] European Medicines Agency. “XELODA (Capecitabine) European Approval Records.” 2022.
[4] Oncology Drug Market Reports. “Global Oral Chemotherapy Market Analysis.” 2023.
[5] Roche Reports. “Annual Oncology Portfolio Update.” 2023.