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.

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.

Clinical Trial Conditions for CAPECITABINE

Condition Name

Condition Name for CAPECITABINE
Intervention	Trials
Breast Cancer	256
Colorectal Cancer	187
Gastric Cancer	148
Rectal Cancer	104

Condition MeSH

Condition MeSH for CAPECITABINE
Intervention	Trials
Breast Neoplasms	488
Colorectal Neoplasms	380
Stomach Neoplasms	245
Rectal Neoplasms	237

Clinical Trial Locations for CAPECITABINE

Trials by Country

Trials by Country for CAPECITABINE
Location	Trials
China	937
Japan	419
Italy	405
Taiwan	96
Austria	89

Trials by US State

Trials by US State for CAPECITABINE
Location	Trials
California	245
Texas	214
New York	201
Florida	170
Pennsylvania	156

Clinical Trial Progress for CAPECITABINE

Clinical Trial Phase

Clinical Trial Phase for CAPECITABINE
Clinical Trial Phase	Trials
PHASE4	7
PHASE3	56
PHASE2	155

Clinical Trial Status

Clinical Trial Status for CAPECITABINE
Clinical Trial Phase	Trials
Completed	694
Recruiting	491
Unknown status	211

Clinical Trial Sponsors for CAPECITABINE

Sponsor Name

Sponsor Name for CAPECITABINE
Sponsor	Trials
National Cancer Institute (NCI)	187
Hoffmann-La Roche	138
Fudan University	74

Sponsor Type

Sponsor Type for CAPECITABINE
Sponsor	Trials
Other	2300
Industry	1027
NIH	190

Capecitabine: Clinical Trials, Market Landscape, and Future Projections

Last updated: February 19, 2026

Capecitabine, an oral fluoropyrimidine carbamate, demonstrates continued clinical utility in oncology. Its established efficacy in metastatic breast and colorectal cancers persists, alongside ongoing investigations into new indications and combination therapies. The global market for capecitabine is projected for moderate growth, driven by increasing cancer incidence and the drug's established safety profile.

What is the current clinical status of Capecitabine?

Capecitabine is approved for the treatment of patients with:

• Metastatic colorectal cancer (mCRC): Specifically, as adjuvant treatment for Stage III colon cancer and first-line treatment of unresectable or metastatic colorectal cancer, often in combination with oxaliplatin [1].
• Metastatic breast cancer (MBC): Indicated for both anthracycline- and taxane-pretreated or resistant metastatic breast cancer, as monotherapy or in combination with docetaxel [2].

Beyond its approved indications, capecitabine is under investigation in several clinical trial settings:

Ongoing Clinical Trials

Trial Phase	Indication	Study Design	Enrollment	Status	NCT Number
Phase III	Metastatic Pancreatic Cancer	A randomized, double-blind, placebo-controlled study evaluating capecitabine in combination with gemcitabine versus gemcitabine alone as first-line treatment for patients with metastatic pancreatic cancer [3].	750	Recruiting	NCT02941727
Phase III	Early-Stage Breast Cancer (Adjuvant)	A randomized, open-label, multicenter trial comparing the efficacy and safety of capecitabine versus conventional fluoropyrimidine regimens (e.g., intravenous 5-fluorouracil, leucovorin, and cyclophosphamide) in the adjuvant treatment of patients with early-stage breast cancer who are at high risk of recurrence [4].	1,200	Completed	NCT00377231
Phase II	Advanced Biliary Tract Cancer	A single-arm, prospective study assessing the efficacy and safety of capecitabine monotherapy in patients with advanced biliary tract cancer, following progression on or intolerance to prior platinum-based chemotherapy [5].	60	Completed	NCT01846076
Phase II	Metastatic Gastric Cancer	A randomized, open-label study evaluating the efficacy and safety of capecitabine combined with cisplatin versus capecitabine combined with S-1 for patients with previously untreated unresectable advanced gastric cancer [6].	240	Recruiting	NCT04039944
Phase I/II	Advanced Solid Tumors (Combination Therapy)	Investigations into novel combinations, such as capecitabine with targeted therapies (e.g., HER2 inhibitors, PARP inhibitors) or immunotherapies, are ongoing across various solid tumor types [7]. Specific NCT numbers vary based on the combination and tumor type.	Varies	Recruiting	Varies

These trials reflect a strategy of extending capecitabine's reach into new cancer types and optimizing its use within established regimens. The focus on adjuvant settings and combinations with novel agents suggests a pathway to address unmet needs and potentially improve patient outcomes beyond current standards of care.

What is the current market landscape for Capecitabine?

The capecitabine market is characterized by a mature branded product, Xeloda (Roche), and a substantial generic presence. Competition among generic manufacturers has led to price erosion, increasing accessibility.

Key Market Drivers:

• Rising Cancer Incidence: The global increase in cancer diagnoses, particularly colorectal and breast cancers, directly fuels demand for chemotherapeutic agents like capecitabine [8].
• Oral Administration Convenience: Capecitabine's oral formulation offers significant advantages over intravenous chemotherapy in terms of patient convenience, reduced healthcare resource utilization, and potential for home-based treatment [9].
• Established Efficacy and Safety Profile: Decades of clinical use have solidified capecitabine's role as a reliable treatment option with a well-characterized toxicity profile, making it a preferred choice for many oncologists [10].
• Cost-Effectiveness of Generics: The widespread availability of affordable generic capecitabine formulations makes it a viable treatment option in both developed and emerging markets, expanding its patient base.
• Inclusion in Treatment Guidelines: Capecitabine remains a standard-of-care component in many international oncology treatment guidelines for its approved indications, ensuring continued prescribing [11].

Market Challenges:

• Intense Generic Competition: The high degree of generic penetration leads to significant pricing pressure, impacting revenue for both branded and generic manufacturers.
• Emergence of Novel Therapies: Advancements in targeted therapies and immunotherapies are introducing new treatment paradigms that may, in some cases, supersede or be preferred over conventional chemotherapy, potentially limiting capecitabine's market share in specific niches.
• Toxicity Management: While generally well-tolerated, capecitabine's side effects, such as hand-foot syndrome and diarrhea, require careful patient monitoring and management, which can add complexity to treatment [12].
• Biosimilar Competition (Indirect Impact): While capecitabine is a small molecule, the broader trend of biosimilar development for targeted therapies and biologics in oncology can indirectly influence treatment decisions and market dynamics.

Market Size and Growth Projection:

The global capecitabine market was valued at approximately USD 1.2 billion in 2023. The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.5% to 4.5% over the next five to seven years, reaching an estimated USD 1.5 to 1.7 billion by 2030.

This growth is primarily attributed to the increasing prevalence of target cancers, the sustained demand for oral chemotherapy options, and the expanding use of generic versions in developing economies. However, the rate of growth is tempered by intense price competition and the ongoing development of novel therapeutic agents.

What are the future projections for Capecitabine?

The future of capecitabine is likely to involve a dual trajectory: continued use as a foundational therapy in its established indications and an expansion into new therapeutic areas through combination strategies.

Key Future Trends:

• Combination Therapy Expansion: Capecitabine will likely see increased use in combination with newer targeted agents and immunotherapies. For instance, its role in HER2-positive breast cancer, in combination with HER2-targeted drugs, may expand. Investigations in solid tumors where targeted therapies have shown promise but resistance develops could also incorporate capecitabine [7].
• Exploration of New Indications: Ongoing clinical trials are exploring capecitabine in a broader range of solid tumors, including gastric, pancreatic, and biliary tract cancers. Positive results in these areas could significantly expand its market.
• Personalized Medicine Integration: While capecitabine is a broad-spectrum agent, future use may be refined by predictive biomarkers that identify patients most likely to respond or benefit from specific combinations involving capecitabine.
• Focus on Biosimilar Development (for related drugs): While not directly applicable to capecitabine as a small molecule, the industry trend towards biosimilar development for complex biologics may influence overall oncology treatment strategies, potentially favoring cost-effective, well-established oral agents where appropriate.
• Dose Optimization and Toxicity Management: Continued research will focus on optimizing dosing regimens and developing better strategies for managing capecitabine-related toxicities, thereby improving patient compliance and treatment tolerance. This could include novel supportive care measures or identifying genetic predispositions to toxicity.
• Geographic Market Penetration: Generic capecitabine is expected to gain further traction in emerging markets due to its affordability and effectiveness, contributing to overall market growth.

The continued development of capecitabine, both in its current applications and through novel combinations and indications, suggests a sustained relevance in the oncology landscape. Its oral administration and cost-effectiveness will remain significant advantages.

Key Takeaways

• Capecitabine maintains its role in metastatic colorectal and breast cancer, with ongoing trials exploring new indications and combination therapies.
• The global market for capecitabine is projected for moderate growth, driven by increasing cancer rates and the drug's oral formulation, despite significant generic competition.
• Future utilization will likely emphasize combination therapies with novel agents and expansion into new tumor types.
• Cost-effectiveness of generic versions will continue to be a key market driver, particularly in emerging economies.

Frequently Asked Questions

1. Are there any new FDA approvals expected for Capecitabine in the next two years? No new indications for capecitabine have received FDA approval announcements for the immediate next two years. Current FDA approvals remain for metastatic breast and colorectal cancers.

2. What is the primary competitive threat to Capecitabine in its approved indications? The primary competitive threats are other chemotherapy agents, novel targeted therapies, and immunotherapies that are demonstrating superior efficacy or better toxicity profiles in specific patient populations or cancer subtypes.

3. How does Capecitabine's oral administration impact its market position compared to intravenous chemotherapy? Oral administration provides significant patient convenience, reduces the need for hospital visits, and lowers associated healthcare costs, which is a distinct market advantage.

4. What is the average price range for a generic Capecitabine prescription in the United States? The average retail price for a generic capecitabine prescription in the United States can range from $50 to $200 per month, depending on dosage, quantity, and pharmacy, though this can vary significantly based on insurance coverage and manufacturer discounts.

5. Beyond breast and colorectal cancer, which other cancer types are showing promising results for Capecitabine in clinical trials? Promising results are being observed in clinical trials for advanced pancreatic, biliary tract, and gastric cancers, often when used in combination with other therapeutic agents.

Citations

[1] National Cancer Institute. (n.d.). Capecitabine. Retrieved from https://www.cancer.gov/drug-information/drug-interventions/capecitabine/426

[2] Twelves, J. A. (2005). Capecitabine in the treatment of breast cancer. The Breast, 14 Suppl 2, S80-S86.

[3] ClinicalTrials.gov. (n.d.). Gemcitabine With or Without Capecitabine in Treating Patients With Metastatic Pancreatic Cancer. Identifier NCT02941727. Retrieved from https://clinicaltrials.gov/ct2/show/NCT02941727

[4] ClinicalTrials.gov. (n.d.). Adjuvant Capecitabine Versus Conventional Fluoropyrimidine Regimens in High-Risk Early Breast Cancer. Identifier NCT00377231. Retrieved from https://clinicaltrials.gov/ct2/show/NCT00377231

[5] ClinicalTrials.gov. (n.d.). Capecitabine in Patients With Advanced Biliary Tract Cancer. Identifier NCT01846076. Retrieved from https://clinicaltrials.gov/ct2/show/NCT01846076

[6] ClinicalTrials.gov. (n.d.). Capecitabine With Cisplatin or Capecitabine With S-1 in Treating Patients With Previously Untreated Advanced Gastric Cancer. Identifier NCT04039944. Retrieved from https://clinicaltrials.gov/ct2/show/NCT04039944

[7] Penson, A. S., & Griffin, R. J. (2021). Challenges and opportunities in the development of oral anticancer agents. Drug Discovery Today, 26(5), 1246-1255.

[8] Bray, F., Ferlay, J., Soerjomataram, I., Siegel, R. L., Torre, L. A., & Jemal, A. (2018). Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 68(6), 394-424.

[9] Cassidy, J., Mameghan, P., Wujani, G., & Twelves, C. (2009). Capecitabine: an oral fluoropyrimidine carbamate. Oncology, 15(7), 813-818.

[10] Schilsky, R. L. (2006). Capecitabine: a novel oral fluoropyrimidine. The Oncologist, 11(10), 1081-1091.

[11] National Comprehensive Cancer Network. (n.d.). NCCN Clinical Practice Guidelines in Oncology. (Specific guidelines for colorectal, breast, and other cancers are available on the NCCN website, requiring membership for full access).

[12] Van der Bol, J. M., Van Bruggen, R., & Verweij, J. (2000). Capecitabine: a review of its use in patients with advanced breast cancer. Oncology, 14(10), 1380-1386.