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.

Clinical Trial Conditions for CAMPTOSAR

Condition Name

Condition Name for CAMPTOSAR
Intervention	Trials
Colorectal Cancer	20
Recurrent Rectal Cancer	14
Recurrent Colon 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

CAMPTOSAR Market Analysis and Financial Projection

Last updated: April 28, 2026

CAMPTOSAR (irinotecan): Clinical Trials Update, Market Analysis, and Projection

What is CAMPTOSAR and how is it positioned clinically?

CAMPTOSAR is the brand name for irinotecan (ATC: L01XX19), a topoisomerase I inhibitor. It is used in oncology across multiple regimens, most notably:

• Metastatic colorectal cancer (mCRC) in combination with 5-FU/folinic acid and with bevacizumab or cetuximab depending on biomarker and prior therapy lines.
• Metastatic disease after progression on prior therapies in standard irinotecan-containing sequences.
• Additional use in small-cell lung cancer (SCLC) combinations in certain geographies and practice settings.

Irinotecan is administered as intravenous infusion in cyclical chemotherapy schedules; dosing and scheduling depend on regimen and patient factors.

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What do current clinical-trials dynamics imply for CAMPTOSAR?

Irinotecan sits in a mature therapeutic class with ongoing activity concentrated in:

• Optimization of combination regimens (sequencing and partnering with newer agents).
• Biomarker-driven patient selection and supportive-care strategies that improve deliverable dose intensity.
• Formulation and delivery improvements to mitigate tolerability constraints (notably diarrhea and neutropenia), which affects effective treatment duration.

Because CAMPTOSAR is the registered brand for a widely used active ingredient, many active studies in the irinotecan universe are labeled at the molecule level (irinotecan) or include brand variants in protocol arms. Trial updates in this space typically show steady but non-disruptive incremental progress, with trial counts and patient recruitment shifting as new combo standards emerge (immunotherapy backbones for mCRC and targeted-therapy strategies in biomarker-defined subsets).

Clinical takeaways for commercial planning

• The clinical pipeline impact is more likely to come from regimen expansion and repositioning in combination therapy than from a new first-line standalone indication.
• The dominant value driver remains reliable supply and competitive pricing in established chemo pathways, with secondary value from any branded differentiation (switching, tender positioning, or country-specific reimbursement).

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What is CAMPTOSAR’s market profile (demand drivers and competition)?

Demand drivers

• Persistent incidence of colorectal cancer, continued use of multi-agent chemotherapy, and patient flow through second- and subsequent-line settings that commonly include irinotecan.
• Ongoing utilization in biomarker-defined and prior-therapy-defined treatment pathways in mCRC, including settings where irinotecan-containing combinations remain a standard option.
• Continued chemotherapy infrastructure use: oncology centers run stable chemo protocols with predictable cycle economics.

Competitive landscape

• Generic irinotecan is a key pricing and margin pressure in most mature markets.
• Brand survival and share retention depend on:
  • Country-level tender dynamics
  • Hospital formulary preference
  • Supply reliability
  • Contracted price positioning
  • Any differentiation in packaging, stability, or patient support programs (where permitted)

In practice, CAMPTOSAR demand is constrained where generics are aggressively adopted, while it holds stronger positions where reimbursement and procurement favor branded products or where switching is limited by local purchasing contracts.

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Where does growth come from: volume, price, or regimen mix?

For a mature cytotoxic like irinotecan, growth typically comes from one or more of these levers:

• Volume growth: expanded treatment penetration in eligible populations, driven by epidemiology and broader adoption of chemo pathways.
• Regimen mix: irinotecan is used in combination strategies; shifts in partner drugs and sequencing can increase total irinotecan exposure per patient.
• Price protection pockets: formularies where branded procurement persists due to contract structure and clinician preference, even after generic entry.

In most markets, price erosion from generics is the dominant financial factor. Any positive net growth typically requires either (1) partial brand protection in certain tenders or (2) increased utilization from regimen expansion that offsets unit price declines.

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How should CAMPTOSAR market projections be modeled (base case structure)?

Market projections for branded irinotecan generally follow a four-component structure:

1. Eligible population volume: mCRC incidence and line-of-therapy distribution where irinotecan regimens remain viable.
2. Treatment penetration: fraction of patients receiving irinotecan-containing regimens by line.
3. Average dose intensity and cycles: impacts delivered units per patient over time.
4. Net price: affected by generic erosion, tender outcomes, and payer reimbursement caps.

A realistic projection uses:

• Stable or slowly changing eligible volumes (driven by cancer epidemiology).
• Gradual penetration shifts with new standards.
• Net price drift downward where generic share expands.
• Potential resilience in geographies with brand-preferred tenders.

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What is the likely 2026-2031 projection direction for CAMPTOSAR?

Base-case projection logic

• Unit demand is likely to remain stable to modestly up in absolute terms because mCRC therapy sequences continue to include irinotecan in multiple lines and combinations.
• Revenue is likely to face pressure due to continued generic penetration and tender price compression.
• Net effect is commonly a flat-to-declining revenue curve unless CAMPTOSAR holds meaningful share in protected procurement environments or benefits from regimen expansion that increases total irinotecan exposure per patient.

Strategic implication for investors and R&D

• The competitive defense of CAMPTOSAR is less about proving clinical superiority and more about maintaining procurement access and minimizing supply disruptions.
• R&D efforts with potential commercial payoff tend to focus on combination differentiation, tolerability improvements, and delivery convenience rather than wholly new clinical endpoints.

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How do clinical trial trends connect to commercial outcomes?

Clinical trials influence CAMPTOSAR demand via:

• Guideline incorporation: regimens proven in trials get adopted into clinical pathways, affecting irinotecan exposure.
• Sequencing rules: trials that define where irinotecan sits relative to targeted agents shift patient flows.
• Patient selection: biomarker-based findings may tighten indications but can also increase average regimen continuation if outcomes improve.

For cytotoxics, the net commercial effect typically shows up as:

• Year-over-year stability in demand volume.
• Quarter-to-quarter movements in tender wins and distribution contracts more than in sudden demand surges.

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Key Takeaways

• CAMPTOSAR (irinotecan) remains embedded in established chemotherapy sequences for cancers dominated by colorectal cancer patient flows.
• Clinical activity in irinotecan is largely centered on combination optimization and tolerability/biomarker strategies rather than transformative monotherapy positioning.
• Market upside is most plausibly driven by regimen mix and utilization persistence, while downside risk is primarily generic-driven net price erosion.
• A practical 2026-2031 model forecasts stable or modestly growing unit demand with revenue pressure unless procurement and tender dynamics protect brand pricing.

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FAQs

1) Is CAMPTOSAR still relevant in current mCRC treatment pathways?

Yes. Irinotecan remains used in multiple lines and combination regimens for metastatic colorectal cancer where chemotherapy backbone treatment continues to apply.

2) What most affects CAMPTOSAR revenue: demand or price?

Price, driven by generic entry and tender dynamics, is typically the dominant driver of branded revenue performance in mature irinotecan markets.

3) What kinds of trials most influence future CAMPTOSAR demand?

Trials that change regimen sequencing, expand combination usage, or refine patient selection that alters where and how often irinotecan is used.

4) What are the main competitive threats?

The primary threat is generic irinotecan in most markets, with secondary threats from competing branded chemo regimens where procurement rules change.

5) What is the most investable angle: clinical pipeline or commercial execution?

For a mature cytotoxic brand, commercial execution (tender wins, supply reliability, contracting) is usually the highest-impact factor, with clinical trials acting mainly through guideline and regimen adoption.

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References

[1] U.S. Food and Drug Administration. CAMPTOSAR (irinotecan hydrochloride) prescribing information.
[2] European Medicines Agency. Campto (irinotecan) summary of product characteristics.
[3] National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Colon Cancer and Rectal Cancer (irinotecan-containing regimens referenced in treatment pathways).
[4] Global Cancer Observatory (GCO), International Agency for Research on Cancer (IARC). Colorectal cancer incidence and mortality statistics.