CLINICAL TRIALS PROFILE FOR TEMOZOLOMIDE

505(b)(2) Clinical Trials for TEMOZOLOMIDE

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	NCT00876993 ↗	Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors	Completed	Brain Tumor Alliance	Phase 1	2008-09-01	Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently in progress within the major consortiums with this combination of drugs. Brain tumors are the second most common cause of cancer in pediatrics and the leading cause of cancer death in children. For children with High Grade Gliomas or with relapsed/refractory brain tumors, new agents in new combinations are needed. Historical data shows that newly diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%. This study is a phase I study designed to provide an objective observation of toxicity and establish a maximum tolerated dose of this combination. In addition, this study will observe the response of children with relapsed or refractory central nervous system tumors.
New Combination	NCT00876993 ↗	Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors	Completed	The V Foundation	Phase 1	2008-09-01	Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently in progress within the major consortiums with this combination of drugs. Brain tumors are the second most common cause of cancer in pediatrics and the leading cause of cancer death in children. For children with High Grade Gliomas or with relapsed/refractory brain tumors, new agents in new combinations are needed. Historical data shows that newly diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%. This study is a phase I study designed to provide an objective observation of toxicity and establish a maximum tolerated dose of this combination. In addition, this study will observe the response of children with relapsed or refractory central nervous system tumors.
New Combination	NCT00876993 ↗	Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors	Completed	V Foundation	Phase 1	2008-09-01	Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently in progress within the major consortiums with this combination of drugs. Brain tumors are the second most common cause of cancer in pediatrics and the leading cause of cancer death in children. For children with High Grade Gliomas or with relapsed/refractory brain tumors, new agents in new combinations are needed. Historical data shows that newly diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%. This study is a phase I study designed to provide an objective observation of toxicity and establish a maximum tolerated dose of this combination. In addition, this study will observe the response of children with relapsed or refractory central nervous system tumors.
New Combination	NCT00876993 ↗	Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors	Completed	Johns Hopkins All Children's Hospital	Phase 1	2008-09-01	Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently in progress within the major consortiums with this combination of drugs. Brain tumors are the second most common cause of cancer in pediatrics and the leading cause of cancer death in children. For children with High Grade Gliomas or with relapsed/refractory brain tumors, new agents in new combinations are needed. Historical data shows that newly diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%. This study is a phase I study designed to provide an objective observation of toxicity and establish a maximum tolerated dose of this combination. In addition, this study will observe the response of children with relapsed or refractory central nervous system tumors.

All Clinical Trials for TEMOZOLOMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003176 ↗	Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma	Completed	National Cancer Institute (NCI)	Phase 2	1998-03-25	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 II trial to study the effectiveness of temozolomide and carmustine in treating patients with anaplastic glioma.
NCT00003176 ↗	Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma	Completed	North American Brain Tumor Consortium	Phase 2	1998-03-25	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 II trial to study the effectiveness of temozolomide and carmustine in treating patients with anaplastic glioma.
NCT00003176 ↗	Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma	Completed	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2	1998-03-25	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 II trial to study the effectiveness of temozolomide and carmustine in treating patients with anaplastic glioma.
NCT00003062 ↗	Temozolomide in Patients With Progressive or Recurrent Non-small Cell Lung Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 2	1997-07-01	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 effect of temozolomide in patients with progressive or recurrent stage IV non-small cell lung cancer, with or without brain metastases, who have not been treated for metastatic disease with chemotherapy.

Clinical Trial Conditions for TEMOZOLOMIDE

Condition Name

Condition Name for TEMOZOLOMIDE
Intervention	Trials
Glioblastoma	221
Glioblastoma Multiforme	129
Brain and Central Nervous System Tumors	89
Gliosarcoma	55

Condition MeSH

Condition MeSH for TEMOZOLOMIDE
Intervention	Trials
Glioblastoma	469
Glioma	196
Central Nervous System Neoplasms	113
Nervous System Neoplasms	109

Clinical Trial Locations for TEMOZOLOMIDE

Trials by Country

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−

Trials by Country for TEMOZOLOMIDE
Location	Trials
Japan	78
Netherlands	56
Switzerland	55
Belgium	53
Austria	33

Trials by US State

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−

Trials by US State for TEMOZOLOMIDE
Location	Trials
California	199
Texas	177
New York	168
North Carolina	153
Ohio	149

Clinical Trial Progress for TEMOZOLOMIDE

Clinical Trial Phase

Clinical Trial Phase for TEMOZOLOMIDE
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	77
Phase 2/Phase 3	20

Clinical Trial Status

Clinical Trial Status for TEMOZOLOMIDE
Clinical Trial Phase	Trials
Completed	405
Recruiting	175
Not yet recruiting	113

Clinical Trial Sponsors for TEMOZOLOMIDE

Sponsor Name

Sponsor Name for TEMOZOLOMIDE
Sponsor	Trials
National Cancer Institute (NCI)	237
Schering-Plough	37
Merck Sharp & Dohme Corp.	36

Sponsor Type

Sponsor Type for TEMOZOLOMIDE
Sponsor	Trials
Other	1212
Industry	492
NIH	250

Temozolomide: Clinical Trials Update, Market Analysis, and Projections

Introduction to Temozolomide

Temozolomide, commonly known by its brand name Temodar, is a chemotherapeutic agent used primarily in the treatment of brain tumors, particularly glioblastoma multiforme. It works by interfering with the DNA of cancer cells, preventing them from reproducing and ultimately leading to cell death.

Current Clinical Trials

Ongoing Trials and Objectives

Several clinical trials are currently underway to explore the efficacy and safety of temozolomide in various treatment regimens.

Combination Therapy with Radiation

A notable trial is investigating the combination of NanO2 Plus radiation and temozolomide in newly diagnosed glioblastoma patients. This trial, expected to complete in September 2025, aims to assess the safety and efficacy of this combination. Initial findings indicate that while there are serious treatment-emergent adverse events (TEAEs), many are not related to the study medication or radiation[1].

Combination with Other Anti-Cancer Drugs

Another phase I/II trial is testing the combination of temozolomide with tuvusertib (M1774) to determine the maximum tolerated dose and to observe anti-tumor activity. This study also explores the correlation between genetic markers and treatment efficacy, as well as changes in tumor mutational burden and microsatellite status[4].

Extended Treatment Durations

A comparative study is examining the benefits of extending temozolomide treatment from the standard 6 months to 12 months in newly diagnosed glioblastoma multiforme patients. Preliminary results suggest that extended treatment can increase overall survival by over 50%, although it also triples the chances of toxicity[3].

Market Analysis

Global Market Size and Growth

The global temozolomide market has shown significant growth in recent years. As of 2023, the market size was substantial, and it is projected to continue growing at a compound annual growth rate (CAGR) from 2024 to 2031. The market is driven by increasing demand for effective treatments for brain tumors and other cancers[2].

Market Segmentation

The temozolomide market can be segmented by type (capsules and injections), region, and end-use (hospitals, clinics, etc.). Capsules currently account for a significant share of the market due to their ease of administration and patient compliance. The hospital segment is also a major contributor, given the primary use of temozolomide in hospital settings[2].

Regional Analysis

The global temozolomide market is expected to be dominated by regions with high incidence rates of brain tumors and advanced healthcare infrastructure. North America and Europe are anticipated to be key markets, followed by Asia-Pacific, which is expected to grow rapidly due to increasing healthcare spending and awareness[5].

Market Drivers and Restraints

Drivers

• Increasing Incidence of Brain Tumors: The rising number of brain tumor cases globally is a significant driver for the temozolomide market.
• Advancements in Treatment Regimens: Ongoing clinical trials exploring new combinations and treatment durations are expected to enhance the market.
• Improving Healthcare Infrastructure: Better access to healthcare facilities, especially in developing regions, is boosting the demand for temozolomide.

Restraints

• Side Effects and Toxicity: The potential for serious adverse events, as seen in extended treatment durations, is a significant restraint.
• High Cost: Temozolomide treatment can be expensive, limiting access in some regions.
• Competition from Alternative Treatments: Emerging therapies and treatments may compete with temozolomide, affecting market growth[2][5].

Market Projections

Forecast Period

From 2025 to 2031, the global temozolomide market is forecasted to grow at a steady CAGR. This growth will be driven by the increasing adoption of temozolomide in standard treatment protocols, expanding healthcare infrastructure, and ongoing research into more effective treatment regimens[2][5].

Key Trends

• Personalized Medicine: Future trends may include personalized treatment plans based on genetic markers, such as MGMT promoter hypermethylation, which can influence treatment efficacy[4].
• Combination Therapies: The exploration of temozolomide in combination with other anti-cancer drugs is expected to continue, potentially leading to more effective treatment options[4].

Conclusion

Temozolomide remains a crucial drug in the treatment of brain tumors, particularly glioblastoma multiforme. Ongoing clinical trials are exploring new treatment regimens and combinations to enhance efficacy and reduce toxicity. The global market for temozolomide is projected to grow significantly, driven by increasing demand and advancements in healthcare.

Key Takeaways

• Clinical Trials: Ongoing trials are investigating the combination of temozolomide with radiation and other anti-cancer drugs, as well as extended treatment durations.
• Market Growth: The global temozolomide market is expected to grow at a steady CAGR from 2025 to 2031.
• Market Drivers: Increasing incidence of brain tumors, advancements in treatment regimens, and improving healthcare infrastructure are key drivers.
• Market Restraints: Side effects, high cost, and competition from alternative treatments are significant restraints.
• Future Trends: Personalized medicine and combination therapies are expected to shape the future of temozolomide treatment.

FAQs

What is the primary use of temozolomide?

Temozolomide is primarily used in the treatment of brain tumors, particularly glioblastoma multiforme.

What are the current clinical trials focusing on?

Current trials are exploring the combination of temozolomide with radiation, other anti-cancer drugs like tuvusertib, and extended treatment durations.

What are the key drivers of the global temozolomide market?

The key drivers include the increasing incidence of brain tumors, advancements in treatment regimens, and improving healthcare infrastructure.

What are the potential restraints on the temozolomide market?

Significant restraints include side effects and toxicity, high cost, and competition from alternative treatments.

What trends are expected to shape the future of temozolomide treatment?

Future trends include personalized medicine based on genetic markers and the exploration of combination therapies.

Sources

1. NanO2 Plus Radiation/Temozolomide Is Under Exploration in Newly Diagnosed Glioblastoma. Onclive.
2. Temozolomide Market Report 2024 (Global Edition). Cognitive Market Research.
3. Brain Tumor News Articles About Temodar or Temozolomide. VirtualTrials.org.
4. Testing the Combination of the Anti-Cancer Drugs Temozolomide and Tuvusertib. ClinicalTrials.ucsd.edu.
5. Global Temozolomide Market Growth 2024-2030. Market Research Reports.