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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR CAMPTOSAR


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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 TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
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.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

All Clinical Trials for Camptosar

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for Camptosar

Condition Name

201414110-20246810121416182022Colorectal CancerRecurrent Colon CancerRecurrent Rectal CancerPancreatic Cancer[disabled in preview]
Condition Name for Camptosar
Intervention Trials
Colorectal Cancer 20
Recurrent Colon Cancer 14
Recurrent Rectal Cancer 14
Pancreatic Cancer 11
[disabled in preview] 0
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Condition MeSH

545038350-50510152025303540455055Colorectal NeoplasmsAdenocarcinomaNeoplasmsPancreatic Neoplasms[disabled in preview]
Condition MeSH for Camptosar
Intervention Trials
Colorectal Neoplasms 54
Adenocarcinoma 50
Neoplasms 38
Pancreatic Neoplasms 35
[disabled in preview] 0
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Clinical Trial Locations for Camptosar

Trials by Country

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

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Trials by US State for Camptosar
Location Trials
California 66
Texas 49
New York 48
Tennessee 43
Pennsylvania 43
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Clinical Trial Progress for Camptosar

Clinical Trial Phase

7.2%45.9%46.4%00102030405060708090100Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for Camptosar
Clinical Trial Phase Trials
Phase 4 1
Phase 3 15
Phase 2 96
[disabled in preview] 97
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Clinical Trial Status

51.5%18.8%14.4%15.3%030405060708090100110CompletedTerminatedRecruiting[disabled in preview]
Clinical Trial Status for Camptosar
Clinical Trial Phase Trials
Completed 104
Terminated 38
Recruiting 29
[disabled in preview] 31
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Clinical Trial Sponsors for Camptosar

Sponsor Name

trials0102030405060708090100National Cancer Institute (NCI)Genentech, Inc.M.D. Anderson Cancer Center[disabled in preview]
Sponsor Name for Camptosar
Sponsor Trials
National Cancer Institute (NCI) 92
Genentech, Inc. 12
M.D. Anderson Cancer Center 10
[disabled in preview] 15
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Sponsor Type

47.4%29.6%23.0%0020406080100120140160180200OtherIndustryNIH[disabled in preview]
Sponsor Type for Camptosar
Sponsor Trials
Other 192
Industry 120
NIH 93
[disabled in preview] 0
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CAMPTOSAR (Irinotecan): Clinical Trials, Market Analysis, and Projections

Introduction

CAMPTOSAR, also known as irinotecan, is a topoisomerase inhibitor used primarily in the treatment of metastatic colorectal cancer. Here, we will delve into recent clinical trials, market analysis, and projections for this drug.

Clinical Trials and Efficacy

Recent Clinical Trials

A significant recent clinical trial is the AtezoTRIBE study, a phase II randomized trial that evaluated the efficacy of first-line fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) combined with bevacizumab, with or without atezolizumab, in patients with metastatic colorectal cancer (mCRC)[4].

  • Outcomes: The study reported a median overall survival (OS) of 33.0 months for the experimental group (FOLFOXIRI/bevacizumab plus atezolizumab) and 27.2 months for the control group (FOLFOXIRI/bevacizumab alone). The hazard ratio was 0.78, indicating a survival benefit for the experimental group.
  • Biomarker Analysis: The study also highlighted the importance of tumor immune-related biomarkers. Patients with high Immunoscore Immune-Checkpoint (IC) and high tumor mutational burden (TMB) derived greater benefit from the addition of atezolizumab.

Standard Treatment Regimens

CAMPTOSAR is indicated as part of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. It is also used for patients whose disease has recurred or progressed following initial fluorouracil-based therapy[1].

Market Analysis

Global Market Size and Growth

The global irinotecan market was valued at USD 9.2 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 6.5% from 2023 to 2030[2].

  • Regional Breakdown: The market is segmented by region, with North America accounting for $3.496 billion, Europe for $2.944 billion, Asia Pacific for $2.116 billion, South America for $0.46 billion, and the Middle East and Africa for $0.184 billion in 2023.
  • Asia Pacific Dominance: The Asia Pacific region dominated the market in 2023, driven by a large and growing population, increasing cancer cases, cost-effective manufacturing, and improved healthcare access[2].

Drivers of Market Growth

Several factors are driving the growth of the irinotecan market:

  • Precision Medicine: The field of precision medicine has significantly expanded, allowing for more targeted and effective therapies. Companion diagnostic tests help identify patients who will benefit most from irinotecan, reducing side effects and improving treatment efficacy[2].
  • Genetic Markers: Research on genetic markers such as UGT1A1 has become crucial in determining a patient's tolerance and reaction to irinotecan. This has led to the development of irinotecan-based treatments customized for specific genetic profiles[2].
  • Regulatory Approvals: Regulatory approvals and the growing emphasis on precision medicine in regions like Latin America and the Middle East & Africa are also driving market growth[2].

Market Projections

Forecast Period

The forecast period for the irinotecan market spans from 2025 to 2031, with the base year being 2023. During this period, the market is expected to continue its growth trajectory driven by the factors mentioned above[2].

Competitive Landscape

The market is competitive, with several pharmaceutical companies involved in the development and marketing of irinotecan-based treatments. The proposed acquisition of Aventis by Sanofi-Synthelabo, for example, had significant implications for the competitive landscape in the U.S. cytotoxic colorectal cancer drug market, highlighting the need for regulatory oversight to prevent anticompetitive effects[3].

Side Effects and Management

Common Side Effects

CAMPTOSAR is associated with several side effects, including severe diarrhea, myelosuppression, and neutropenia. Management strategies include prompt treatment of diarrhea with loperamide, fluid and electrolyte replacement, and antibiotic therapy if necessary. Dose adjustments and treatment delays may also be required to manage these side effects[1].

Key Takeaways

  • Clinical Trials: Recent trials like the AtezoTRIBE study demonstrate the efficacy of irinotecan in combination regimens for mCRC, highlighting the importance of biomarkers.
  • Market Growth: The global irinotecan market is projected to grow at a CAGR of 6.5% from 2023 to 2030, driven by precision medicine, genetic markers, and regulatory approvals.
  • Regional Dominance: The Asia Pacific region is a significant market due to its large population, increasing cancer cases, and cost-effective manufacturing.
  • Side Effects Management: Effective management of side effects such as diarrhea and myelosuppression is crucial for patient outcomes.

FAQs

What is CAMPTOSAR used for?

CAMPTOSAR (irinotecan) is used as part of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum, and for patients whose disease has recurred or progressed following initial fluorouracil-based therapy[1].

What are the common side effects of CAMPTOSAR?

Common side effects include severe diarrhea, myelosuppression, and neutropenia. These side effects require prompt management to prevent severe complications[1].

How is the global irinotecan market projected to grow?

The global irinotecan market is projected to grow at a CAGR of 6.5% from 2023 to 2030, reaching a significant market size driven by various factors including precision medicine and genetic markers[2].

Which region dominates the irinotecan market?

The Asia Pacific region dominates the irinotecan market due to its large and growing population, increasing cancer cases, cost-effective manufacturing, and improved healthcare access[2].

What role do genetic markers play in irinotecan treatment?

Genetic markers such as UGT1A1 are crucial in determining a patient's tolerance and reaction to irinotecan. This has led to the development of customized treatments based on genetic profiles, maximizing treatment efficacy and reducing side effects[2].

What is the significance of the AtezoTRIBE study?

The AtezoTRIBE study highlights the efficacy of combining irinotecan with other chemotherapeutic agents and immunotherapy (atezolizumab) in improving overall survival for patients with metastatic colorectal cancer, particularly those with high Immunoscore Immune-Checkpoint and high tumor mutational burden[4].

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