CLINICAL TRIALS PROFILE FOR CAMPTOSAR

505(b)(2) Clinical Trials for CAMPTOSAR

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	NCT00177853 ↗	Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer	Terminated	Pharmacia and Upjohn	Phase 1	2006-12-01	The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
New Combination	NCT00177853 ↗	Celecoxib, Irinotecan and Concurrent Radiotherapy in Preoperative Pancreatic Cancer	Terminated	University of Pittsburgh	Phase 1	2006-12-01	The purposes of this study are to examine the effects of a new combination of drugs, celecoxib (Celebrex®) and irinotecan (CPT-11), with standard radiation therapy on people before they undergo surgery; to determine what effects this combination has on pancreatic cancer; and to determine the highest dose of celecoxib and irinotecan that can be given safely without causing severe side effects. While not an endpoint, it is hoped that this combination will also shrink tumors enough for excision.
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.

All Clinical Trials for CAMPTOSAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003970 ↗	Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma	Completed	National Cancer Institute (NCI)	Phase 1	1999-01-01	Phase I trial to study genetic testing and the effectiveness of irinotecan in treating patients who have solid tumors and lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Genetic testing for a specific enzyme may help doctors determine whether side effects from or response to chemotherapy are related to a person's genetic makeup
NCT00004078 ↗	Irinotecan in Treating Children With Refractory Solid Tumors	Completed	National Cancer Institute (NCI)	Phase 2	1999-10-01	This phase II trial is studying irinotecan to see how well it works in treating children with refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
NCT00004078 ↗	Irinotecan in Treating Children With Refractory Solid Tumors	Completed	Children's Oncology Group	Phase 2	1999-10-01	This phase II trial is studying irinotecan to see how well it works in treating children with refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
NCT00004103 ↗	Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1998-07-01	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 and combining chemotherapy with surgery may kill more tumor cells. PURPOSE: This phase II trial is studying how well irinotecan and cisplatin followed by surgery, floxuridine, and cisplatin work in treating patients with stomach cancer.
NCT00004103 ↗	Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer	Completed	New York University School of Medicine	Phase 2	1998-07-01	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 and combining chemotherapy with surgery may kill more tumor cells. PURPOSE: This phase II trial is studying how well irinotecan and cisplatin followed by surgery, floxuridine, and cisplatin work in treating patients with stomach cancer.

Clinical Trial Conditions for CAMPTOSAR

Condition Name

Condition Name for CAMPTOSAR
Intervention	Trials
Colorectal Cancer	20
Recurrent Colon Cancer	14
Recurrent Rectal Cancer	14
Unspecified Adult Solid Tumor, Protocol Specific	11

Condition MeSH

Condition MeSH for CAMPTOSAR
Intervention	Trials
Colorectal Neoplasms	54
Adenocarcinoma	50
Neoplasms	38
Pancreatic Neoplasms	35

Clinical Trial Locations for CAMPTOSAR

Trials by Country

Trials by Country for CAMPTOSAR
Location	Trials
Canada	88
Australia	44
United Kingdom	23
Japan	19
Spain	17

Trials by US State

Trials by US State for CAMPTOSAR
Location	Trials
California	66
Texas	49
New York	48
Pennsylvania	43
Illinois	43

Clinical Trial Progress for CAMPTOSAR

Clinical Trial Phase

Clinical Trial Phase for CAMPTOSAR
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	15
Phase 2	96

Clinical Trial Status

Clinical Trial Status for CAMPTOSAR
Clinical Trial Phase	Trials
Completed	104
Terminated	38
Recruiting	29

Clinical Trial Sponsors for CAMPTOSAR

Sponsor Name

Sponsor Name for CAMPTOSAR
Sponsor	Trials
National Cancer Institute (NCI)	92
Genentech, Inc.	12
M.D. Anderson Cancer Center	10

Sponsor Type

Sponsor Type for CAMPTOSAR
Sponsor	Trials
Other	192
Industry	120
NIH	93

Clinical Trials Update, Market Analysis, and Future Projections for Camptosar (Irinotecan)

Last updated: October 28, 2025

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Introduction

Camptosar (irinotecan) remains a cornerstone chemotherapeutic agent primarily used in the treatment of metastatic colorectal cancer (mCRC). With recent advancements in oncology and emerging therapeutic strategies, ongoing clinical trials and evolving market dynamics significantly influence Camptosar’s future positioning. This article offers an in-depth update on Camptosar-related clinical trials, analyzes its current market landscape, and provides projections based on emerging data and industry trends.

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Clinical Trials Update

Current Clinical Trials Landscape

As of 2023, Camptosar continues to feature prominently in several clinical investigations targeting colorectal, gastric, and lung cancers. The focus areas include combination therapies, dosing regimens, and resistance mechanisms. A comprehensive review of ongoing trials indicates:

• Combination Therapies: Multiple phase I/II trials explore irinotecan in combination with immunotherapies, such as PD-1/PD-L1 inhibitors (e.g., pembrolizumab), to enhance efficacy in resistant tumors. For instance, a trial registered under ClinicalTrials.gov (NCT04971268) assesses the safety and efficacy of irinotecan combined with pembrolizumab in metastatic colorectal carcinoma with MSI-H/dMMR status.

• Novel Formulations: Investigations into liposomal and nanoparticle formulations aim to improve tumor targeting and reduce systemic toxicities, as seen in studies like NCT03941249 evaluating liposomal irinotecan (Onivyde) in GI cancers.

• Biomarker-Driven Approaches: Emerging data supports integrating genetic markers (e.g., UGT1A1 polymorphisms) to personalize dosing and mitigate adverse effects (NCT04566866).

Key Results & Insights

• Although results are preliminary, early-phase trials indicate that combining irinotecan with immunotherapies yields promising response rates in selected patient subgroups.
• Novel formulations are demonstrating improved pharmacokinetics and reduced toxicity; however, larger confirmatory trials are pending.
• Resistance mechanisms ongoing research aims to identify predictive biomarkers, potentially broadening patient eligibility and optimizing treatment outcomes.

Regulatory and Approval Updates

While no major label changes have occurred recently, the FDA's approval of liposomal irinotecan (Onivyde) in combination with fluorouracil and leucovorin for metastatic pancreatic cancer underscores a growing interest in optimized irinotecan derivatives. Clinical trials exploring irinotecan's utility in other indications continue to pave the way for potential label expansions.

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Market Analysis

Current Market Landscape

Camptosar’s global market value was estimated at approximately USD 780 million in 2022, driven predominantly by North America and Europe. The drug's established role in colorectal and gastric cancers sustains steady demand, despite the competitive landscape.

Competitive Dynamics

The oncology pipeline features numerous agents targeting similar indications—such as FOLFIRI (folinic acid, fluorouracil, irinotecan) regimens, as well as targeted therapies and immunotherapies. Notably:

• Patient Preference & Combination Choices: As immunotherapy combinations progress through clinical development, the likelihood of Camptosar being used as a backbone agent persists, especially in treatment-resistant settings.

• Emergence of Biosimilars & Generics: The expiration of exclusivity for some formulations has facilitated entry of biosimilar versions, which may exert pricing pressure.

• Market Penetration & Pricing: Camptosar remains a high-cost therapeutic, with prices around USD 3,500 per 100 mg dose. Payers increasingly scrutinize value propositions, especially given the advent of targeted and immune-based therapies.

Geographical & Demographic Trends

• North America: Dominates sales owing to established clinical protocols and reimbursement infrastructure.
• Europe: Closely follows, with adoption driven by clinical guideline updates.
• Asia-Pacific: Growing markets facilitated by rising cancer incidence, local manufacturing, and increasing healthcare expenditure.

Future Market Projections

Based on current trends, the irinotecan market is poised for modest growth at a CAGR of 2-3% over the next 5 years, reaching approximately USD 900 million by 2027. This outlook considers:

• Increasing adoption of combination regimens incorporating Camptosar.
• Expansion into earlier lines of therapy contingent on ongoing trial outcomes.
• Growing prevalence of colorectal and gastric cancers globally.

Market Challenges & Opportunities

• Challenges: Generic competition, pricing pressures, and evolving treatment paradigms pose risks.
• Opportunities: Personalized medicine approaches, biomarker-guided therapy, and new formulations may enhance clinical utility and market share.

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Future Market Projections

Key Factors Driving Growth

1. Clinical validation of combination therapies: Continued positive trial outcomes could solidify Camptosar’s role in regimens integrating immunotherapy and targeted agents.
2. Regulatory approvals: Potential expanded indications (e.g., in gastric or lung cancers) based on successful trial results.
3. Technological advances: Liposomal or nanoparticle formulations may improve tolerability and patient adherence, gaining clinician favor.

Potential Scenarios

• Base Case: Steady incremental growth driven by ongoing clinical use within established regimens.
• Optimistic Scenario: Market expansion into new indications and validated biomarker-driven personalization could accelerate growth, reaching USD 1 billion in revenue by 2028.
• Pessimistic Scenario: Regulatory hurdles, adverse trial outcomes, or competitive pressures could limit growth, maintaining current levels.

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Key Takeaways

• Camptosar continues to be integral in colorectal cancer management, with ongoing clinical trials exploring novel combinations and formulations.
• Market growth is expected to be moderate, supported by emerging evidence, regulatory developments, and global cancer prevalence.
• The evolving treatment landscape, notably immunotherapy integration, offers both challenges and opportunities for Camptosar’s positioning.
• Enhanced personalization, biomarker integration, and new delivery systems are critical drivers for future market expansion.
• Strategic collaborations and continued innovation will determine Camptosar’s long-term market share and therapeutic relevance.

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FAQs

1. What are the primary indications for Camptosar currently?
Camptosar is primarily indicated for metastatic colorectal cancer, often as part of combination regimens like FOLFIRI. It also has approved uses in gastric and pancreatic cancers.

2. Are there any recent regulatory updates impacting Camptosar?
While no recent approvals or label changes have been announced, the FDA’s approval of liposomal irinotecan (Onivyde) signals ongoing regulatory interest in improved formulations of irinotecan derivatives.

3. How does Camptosar compare to newer targeted therapies?
Camptosar remains standard in specific regimens but faces competition from targeted agents and immunotherapies, especially in tumors expressing relevant biomarkers. Its role is increasingly as part of combination strategies rather than monotherapy.

4. What are the main clinical trial initiatives involving Camptosar?
Current trials focus on combination with immune checkpoint inhibitors, novel formulations for better tolerability, and biomarker-guided dosing to optimize efficacy.

5. What is the outlook for Camptosar’s market share over the next five years?
The outlook is cautiously optimistic, with modest growth driven by clinical validation of combination therapies and new formulations. Market expansion into new indications could further enhance its share.

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References

1. ClinicalTrials.gov. (2023). Various trials involving irinotecan (Camptosar).
2. Grand View Research. (2022). Oncology drugs market analysis.
3. U.S. Food and Drug Administration. (2022). Approval of liposomal irinotecan (Onivyde) for pancreatic cancer.
4. IQVIA. (2023). Global oncology drug sales report.
5. GlobalData. (2022). Oncology pipeline and market forecasts.

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This comprehensive update provides business professionals and healthcare decision-makers valuable insights into Camptosar’s clinical and commercial trajectory, supporting strategic planning within oncology therapeutics.