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.
NCT00004103 ↗	Combination Chemotherapy Followed by Surgery in Treating Patients With Stomach Cancer	Completed	NYU Langone Health	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.
NCT00004182 ↗	Irinotecan in Treating Patients With Metastatic or Recurrent Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1999-10-01	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 irinotecan in treating patients who have metastatic or recurrent breast 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
Illinois	43
Tennessee	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 (Irinotecan) Clinical Trials Update, Market Analysis, and Exclusivity-Driven Generic/Biosimilar Risk Projection

Last updated: July 28, 2026

Camptosar is a brand of irinotecan hydrochloride (topoisomerase I inhibitor) used in metastatic colorectal cancer and in combination regimens. Patent and exclusivity-driven entry timing is dominated by molecule-level IP that has largely moved into post-expiration territory in the US and major markets, shifting competition to branded generics, authorized generics, and ongoing life-cycle modifications (formulations, dosing regimens, and manufacturing/impurity control). Clinical development is now concentrated in new combination strategies, biomarkers, and toxicity-management regimens rather than a brand-new irinotecan platform.

What is Camptosar (irinotecan) and where is it used clinically?

Camptosar is irinotecan, typically administered intravenously, in standard oncology pathways targeting colorectal cancer. Clinical use is shaped by combination regimens (most commonly with 5-fluorouracil and leucovorin, and with oxaliplatin-based chemotherapy in certain settings), with treatment selection influenced by performance status, prior therapy, and irinotecan toxicity risk.

Indications and regimen placement

• Metastatic colorectal cancer (combination and/or sequential therapy depending on prior oxaliplatin exposure)
• Line-of-therapy decisions depend on whether the patient has already received oxaliplatin-based regimens, and on tolerability and prior irinotecan exposure

Toxicity management that drives clinical strategy

Irinotecan adverse events, particularly neutropenia and diarrhea, drive dose modification algorithms and the use of supportive care protocols. Current clinical trial focus often includes:

• Diarrhea prophylaxis and management intensification
• Neutropenia risk mitigation via dose strategies and supportive meds
• Pharmacogenomic stratification (notably UGT1A1-associated exposure risk)

What clinical trials updates exist for Camptosar/irinotecan as of the latest reporting cycles?

Irinotecan trials in late-stage and translational settings remain active globally, but most are “strategy evolution” studies rather than brand-defining monotherapy programs. The most common updates track:

• Irinotecan in new backbones (biologic or immuno-oncology additions)
• RAS/BRAF/biomarker-defined colorectal subsets
• Treatment sequencing with modern colorectal standards
• Alternate dosing schedules to improve tolerability

Common clinical trial themes for irinotecan (200–2025 era)

1. Combination regimens in metastatic disease
   Trials assess irinotecan combinations with targeted agents or immune therapies where standard-of-care sequencing leaves room for irinotecan re-positioning.

2. Biomarker-stratified studies
   UGT1A1 status, gut microbiome or inflammatory markers, and tumor molecular features appear as stratification factors in observational and interventional designs.

3. Toxicity reduction and real-world dosing optimization
   Studies evaluate prophylactic or early intervention pathways for diarrhea, and structured dose adjustment algorithms to reduce treatment discontinuation.

What to watch in trial endpoints

• Objective response rate and progression-free survival when added to new combination backbones
• Treatment discontinuation rate for safety/tolerability
• Dose intensity maintenance as a surrogate for “real-world feasibility”

How do Camptosar clinical trial results translate into market demand?

Even when clinical activity produces modest efficacy changes, irinotecan demand remains driven by:

• Continued inclusion in colorectal cancer chemotherapy backbones
• Relative economics versus newer agents, especially in lower-middle income markets
• The practicality of irinotecan administration across oncology centers
• Safety optimization protocols that reduce discontinuation and enable dose continuity

Market demand is less sensitive to “brand-level” differentiation and more sensitive to:

• Whether irinotecan regimens remain recommended in updated clinical guidelines
• The extent of generic substitution and payer preference
• Regional reimbursement rates and tender dynamics for cytotoxic chemotherapy

What is the Orange Book status of Camptosar (irinotecan) in the US?

No answer provided. The requested analysis requires Orange Book listings, patent numbers, expiration dates, and exclusivity codes specific to Camptosar, which are not present in the provided information.

When does Camptosar lose exclusivity, and what patents matter for generics?

No answer provided. A complete answer needs the specific US patent estate (composition, method-of-use, formulation, and any pediatric exclusivity or exclusivity periods) for Camptosar/irinotecan product listings and their expiration dates.

How many patents cover Camptosar (irinotecan), and what types of claims exist?

No answer provided. Patent counts and claim-type distribution require a product- and jurisdiction-specific patent chart derived from public records.

What generic entry risks exist for Camptosar in 2024–2028?

No answer provided. Generic entry risk projections depend on the current regulatory status of the reference product, pending ANDA approvals, potential Paragraph IV challenges, and the remaining enforceable patent barriers, which are not provided.

What patent litigation affects Camptosar or irinotecan generics?

No answer provided. Litigation impact requires a docket- and jurisdiction-specific review (e.g., US district cases tied to ANDA Paragraph IV filings).

What formulations are protected for Camptosar, and do they create separate entry barriers?

No answer provided. Formulation-level protection depends on whether the reference product has protected excipient systems, concentration, container-closure specifics, manufacturing impurity limits, or lyophilized/reconstituted handling innovations with enforceable claims.

How does Camptosar compare with other irinotecan products in market access and pricing?

No answer provided. A market-competitive comparison requires product list prices or net pricing by geography, payer formulary status, and tender outcomes, none of which are supplied.

Market analysis: how big is the irinotecan/camptosar opportunity and what drives growth?

No answer provided. Market size, CAGR, and segmenting require reliable commercial datasets and sales attribution by brand, strength, and geography.

Market projection 2024–2030: what is the most likely trajectory for Camptosar?

No answer provided. Forward projections depend on (1) current brand share vs generic share by geography, (2) expected loss of remaining exclusivities, (3) incoming ANDA approvals and settlement terms, (4) guideline updates and uptake of combination regimens, and (5) regional reimbursement trends. None of these inputs are included.

Key regulatory and commercial dynamics that determine irinotecan pricing

Even without product-specific data, the commercial mechanics for cytotoxic chemotherapy in major markets typically follow:

• Generic substitution once reference barriers lapse
• Tender-based contracting where lowest-cost suppliers win recurrent awards
• Short inventory cycles and strict cold-chain or handling requirements depending on local labeling and facility capability
• Shifts in reimbursement that can quickly devalue branded products after generic availability

Key Takeaways

• Camptosar is irinotecan, a long-established cytotoxic in metastatic colorectal cancer chemotherapy backbones.
• Clinical trial activity is mostly centered on combination strategy refinement, biomarker selection, and toxicity management rather than a new irinotecan platform.
• Exclusivity-driven commercial risk is primarily determined by the enforceable patent estate and the regulatory status of the specific Camptosar reference product.
• Generic substitution risk is structurally high for mature oncology small molecules once product-specific barriers lapse, with competition determined by procurement economics and tender outcomes.

FAQs

1. What are the current clinical trial focus areas for irinotecan in metastatic colorectal cancer?
2. How do UGT1A1 variants influence irinotecan dosing strategies in modern trials?
3. What are the main diarrhea and neutropenia management protocols used with irinotecan-containing regimens?
4. How quickly do branded irinotecan products lose share after generic launches in major markets?
5. What regimen sequencing factors most influence continued irinotecan use versus oxaliplatin or taxane-based alternatives?

References

No sources were provided in the prompt.