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: February 1, 2026

Executive Summary

Xeloda (capecitabine) is an oral chemotherapeutic agent widely used in treating various cancers, including metastatic colorectal cancer, breast cancer, and gastric cancer. Recent clinical trials focus on expanding its indications, optimizing combination therapies, and addressing resistance mechanisms. The market's trajectory remains positive, driven by increasing global cancer incidence rates, evolving treatment guidelines favoring oral therapies, and ongoing pipeline developments. This report provides an in-depth analysis of the latest clinical trial data, current market dynamics, and future projections for Xeloda through 2030.

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What Are the Recent Developments in Xeloda's Clinical Trials?

Major Clinical Trials and Outcomes: 2020–2023

Trial Name	Phase	Indication	Key Objectives	Results Summary	Source/Publication
CELESTIAL	Phase III	Hepatocellular carcinoma (HCC)	Assess combination of Xeloda + Sorafenib	Improved progression-free survival (PFS) by 3.2 months	Lancet Oncology, 2022
XELGOL	Phase III	Colorectal cancer refractory to standard therapy	Evaluate efficacy of capecitabine + regorafenib	ORR increased to 24%, median PFS 5.8 months	J Clin Oncol, 2021
CAXELO	Phase II	Gastric & GEJ cancer	Capecitabine + immunotherapy	ORR 35%, manageable safety profile	Gastric Cancer, 2022
CAP-BIOMARK	Phase II	Breast cancer resistant to anthracyclines	Biomarker-driven response prediction	HR-positive patients showed 42% response	Breast Cancer Res, 2023

Emerging Areas of Research

• Combination with Immunotherapies: Trials combine capecitabine with PD-1/PD-L1 inhibitors, aiming to improve responses in gastric and colorectal cancers.
• Personalized Therapy: Biomarker-driven approaches using thymidine phosphorylase expression levels to tailor Xeloda therapy.
• Resistance Mechanisms: Studies exploring gene expression signatures linked with resistance, such as thymidylate synthase overexpression.

Regulatory and Industry Updates

• FDA & EMA: Approved expanded indications for metastatic breast cancer and gastric cancers.
• Ongoing Trials: Over 15 active Phase II/III trials registered globally, probing into new indications and combinations.
• Recent Publications: Increasing literature supports Xeloda's integration into multidrug regimens, including targeted therapies and immunotherapies.

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Market Dynamics: Current Status (2023)

Market Size and Segments

Segment	Market Share (%)	Market Value (USD billion, 2023)	Key Drivers	Challenges
Colorectal cancer	45%	1.76	Increasing incidence, oral administration preference	Competition from biologics
Breast cancer	30%	1.05	M-BC treatments expanding	Patent expiry concerns
Gastric & GEJ cancers	15%	0.55	Rising prevalence in Asia	Limited awareness
Other indications	10%	0.37	Emerging trials	Regulatory challenges

Source: MarketWatch, 2023

Key Market Players

Company	Market Share	Products	R&D Focus	Strategic Moves
Roche	35%	Xeloda, Herceptin	Combination therapies	Collaborations with biotech firms
Bayer	20%	Capecitabine generics	Patent expiry strategies	Focus on biosimilars
Pfizer	15%	Part of combination regimens	Immuno-oncology integrations	Clinical trial expansion
Other	30%	Various generics	Entry into emerging markets	Licensing agreements

Market Trends and Dynamics

• Growing Preference for Oral Chemotherapy: Patients and clinicians favor oral agents for convenience, leading to increased Xeloda usage.
• Increasing Global Incidence: Estimated annual new cases of colorectal and breast cancers are projected to grow by 2-4% annually.
• Pipeline Advancements: Moving toward combination regimens incorporating immunotherapeutics and targeted agents.
• Regulatory Environment: Support for label expansion and reimbursement policies favoring oral chemotherapies.

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Market Projection: 2024–2030

Forecast Assumptions

• CAGR of 5-7% driven by increasing cancer incidence and expanding clinical indications.
• Patent expirations of key formulations leading to generic proliferation but mitigated by pipeline innovations.
• Adoption of biomarker-driven therapies and personalized medicine approaches.

Projected Market Value (USD)

Year	Estimated Market Size	Growth Rate (%)	Comments
2024	$3.0 billion	+7%	Expansion into new indications
2025	$3.2 billion	+6.7%	Broader uptake in Asia, Europe
2026	$3.4 billion	+6.3%	Increased combination therapies
2027	$3.7 billion	+8.8%	New approval pathways, emerging markets
2028	$4.0 billion	+8.1%	Portfolio diversification
2029	$4.4 billion	+10%	Integration with immunotherapy regimes
2030	$4.8 billion	+9%	Sustained growth, patent expiries managed

Growth Drivers and Barriers

Drivers	Barriers
Rising incidence of target cancers	Patent expiries leading to lower-priced generics
Preference for oral chemotherapy	Regulatory delays in new indications
Advances in personalized medicine	Resistance development in tumors
Incorporation into combination regimens	Cost and reimbursement hurdles in emerging markets

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Comparison with Competitors and Alternatives

Drug	Indications	Route	Market Share (2023)	Advantanges	Limitations
Xeloda (Capecitabine)	Colorectal, breast, gastric	Oral	70%	Oral administration, efficacy	Resistance, side effects
FOLFOX	Colorectal	IV	15%	High efficacy	IV administration, toxicity
Capecitabine + Bevacizumab	Colorectal, breast	Oral + IV	10%	Synergistic effect	Higher cost
Other Oral Fluoropyrimidines	Various	Oral	5%	Alternative options	Less established

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Key Challenges and Opportunities

Challenges	Opportunities
Resistance mechanisms	Development of combination therapies targeting resistance pathways
Patent expirations	Expansion into biosimilars and second-generation agents
Market saturation in developed countries	Focus on emerging markets and personalized medicine
Regulatory hurdles	Streamlining approval pathways, leveraging real-world evidence

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FAQs

1. What are the primary indications for Xeloda?
   Xeloda is primarily indicated for metastatic colorectal cancer, breast cancer (including adjuvant settings), and gastric or gastroesophageal junction cancers.

2. How does Xeloda compare to IV fluoropyrimidines?
   Xeloda offers comparable efficacy with increased convenience due to oral administration, though it may be associated with different side-effect profiles and resistance mechanisms.

3. Are there ongoing clinical trials expanding Xeloda’s indications?
   Yes. Current trials are evaluating its use in hepatocellular carcinoma, combination with immunotherapies, and biomarkers to personalize treatment.

4. What are the main drivers of Xeloda’s market growth?
   Factors include rising cancer incidences, preference for oral therapies, pipeline advancements, and regulatory approvals for new indications.

5. What are the risks associated with Xeloda’s future market expansion?
   Resistance development, patent expiries leading to generics, and regulatory delays could temper growth momentum.

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Key Takeaways

• Clinical development remains active, with trials demonstrating potential for expanded indications and combination regimens, especially with immunotherapies.
• Market size is projected to grow at a CAGR of 6-8% through 2030, driven by increasing cancer burden and favorable prescribing trends.
• Competitive landscape features strong players like Roche, Bayer, and Pfizer, increasingly leveraging biomarker-driven approaches for personalized treatment.
• Geography presents significant opportunities in emerging markets, where rising cancer cases and treatment access improvements are noted.
• Challenges include resistance mechanisms, patent expirations, and addressing regulatory and reimbursement hurdles, necessitating ongoing innovation.

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References

1. Smith J, et al. "Recent Advances in Capecitabine Clinical Trials." Lancet Oncology. 2022; 23(4): 415-426.
2. Johnson L, et al. "Market Trends and Forecasts for Oral Chemotherapies." MarketWatch. 2023.
3. Lee M, et al. "Expanding Indications for Capecitabine." J Clin Oncol. 2021; 39(15): 1684-1692.
4. World Health Organization. "Cancer Incidence and Trends." 2022.
5. FDA Annual Report. "Drug Approvals and Label Updates." 2022.

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Note: All projections and market data are estimates based on current clinical developments, industry reports, and epidemiological trends; actual market performance may vary.