CLINICAL TRIALS PROFILE FOR TEMODAR

505(b)(2) Clinical Trials for TEMODAR

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	NCT01051596 ↗	A Study of ABT-888 in Combination With Temozolomide for Colorectal Cancer	Completed	Abbott	Phase 2	2009-09-01	People with colorectal cancer that cannot be cured by surgery are being asked to participate in this study. The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with colorectal cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide, and will hopefully increase the killing of cancer cells, and decrease the tumors in the body. ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in colorectal cancer. This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888 has on colorectal cancer. This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide for colorectal cancer.
New Combination	NCT01051596 ↗	A Study of ABT-888 in Combination With Temozolomide for Colorectal Cancer	Completed	Georgetown University	Phase 2	2009-09-01	People with colorectal cancer that cannot be cured by surgery are being asked to participate in this study. The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with colorectal cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide, and will hopefully increase the killing of cancer cells, and decrease the tumors in the body. ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in colorectal cancer. This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888 has on colorectal cancer. This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide for colorectal cancer.
New Combination	NCT01205828 ↗	ABT-888 and Temozolomide for Liver Cancer	Terminated	Abbott	Phase 2	2010-08-01	This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in abbreviation). The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide and will hopefully increase the killing of cancer cells, and decrease the tumors in the body. ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in liver cancer. This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888, has on liver cancer. This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide in liver cancer.

All Clinical Trials for TEMODAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005637 ↗	Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma	Completed	National Cancer Institute (NCI)	Phase 1	1999-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following radiation therapy in treating patients who have malignant glioma.
NCT00005637 ↗	Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma	Completed	Memorial Sloan Kettering Cancer Center	Phase 1	1999-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy following radiation therapy in treating patients who have malignant glioma.
NCT00005951 ↗	Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma	Completed	National Cancer Institute (NCI)	Phase 1	2000-08-01	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 may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.

Clinical Trial Conditions for TEMODAR

Condition Name

Condition Name for TEMODAR
Intervention	Trials
Glioblastoma	86
Glioblastoma Multiforme	45
Gliosarcoma	43

Condition MeSH

Condition MeSH for TEMODAR
Intervention	Trials
Glioblastoma	158
Glioma	69
Gliosarcoma	58

Clinical Trial Locations for TEMODAR

Trials by Country

Trials by Country for TEMODAR
Location	Trials
Canada	118
Australia	57
Japan	34
New Zealand	17
United Kingdom	16

Trials by US State

Trials by US State for TEMODAR
Location	Trials
Texas	94
California	90
North Carolina	76
New York	72
Pennsylvania	70

Clinical Trial Progress for TEMODAR

Clinical Trial Phase

Clinical Trial Phase for TEMODAR
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	18
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for TEMODAR
Clinical Trial Phase	Trials
Completed	136
Active, not recruiting	45
Recruiting	45

Clinical Trial Sponsors for TEMODAR

Sponsor Name

Sponsor Name for TEMODAR
Sponsor	Trials
National Cancer Institute (NCI)	116
M.D. Anderson Cancer Center	28
Genentech, Inc.	16

Sponsor Type

Sponsor Type for TEMODAR
Sponsor	Trials
Other	344
Industry	155
NIH	123

TEMODAR Market Analysis and Financial Projection

Temozolomide: Clinical Trials, Market Analysis, and Projections

Introduction to Temozolomide

Temozolomide, commonly known by its brand name Temodar, is a chemotherapy drug used primarily in the treatment of brain tumors, including glioblastoma multiforme (GBM) and certain types of gliomas. Here, we will delve into recent clinical trials, market analysis, and future projections for this crucial medication.

Clinical Trials Update

Efficacy in Glioblastoma Multiforme (GBM)

Recent clinical trials have provided significant insights into the efficacy of temozolomide in treating GBM. A landmark study comparing the standard "Stupp Protocol" (temozolomide plus radiation) with the addition of the Optune device (a tumor-treating field device) showed a paradigm shift in treatment outcomes. The trial, which started approximately 3.8 months after diagnosis, demonstrated a 50% increase in the number of patients alive at 2 years after starting treatment, rising from 29% in the temozolomide group to 43% in the Optune group. Overall survival increased by about 3 months, from 16.6 to 19.9 months after the trial started[1].

Duration of Temozolomide Treatment

Another study investigated the impact of extending temozolomide treatment from 6 months to 12 months in newly diagnosed GBM patients. While the original trials specified 6 months to expedite the trials, the extended treatment showed a significant increase in overall survival by over 50%. However, this came with a tripled risk of toxicity[1].

Temozolomide in Grade 2 Gliomas

A recent clinical trial funded by the US National Institutes of Health’s National Cancer Institute found that adding temozolomide to radiation therapy significantly improved survival in adult patients with grade 2 gliomas. The 10-year survival rate was 70% with the combined treatment, compared to 47% with radiation alone. This study provides compelling evidence for the benefit of temozolomide in this patient group[4].

Market Analysis

Global Market Size and Growth

The global temozolomide market was estimated at USD 9.01 billion in 2024 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 2.8% from 2024 to 2034. This growth is driven by the increasing incidence of brain and central nervous system (CNS) cancers, with an estimated 347,992 new cases diagnosed worldwide annually[5].

Market Drivers and Challenges

Key drivers of the temozolomide market include the rising prevalence of brain cancers, advancements in treatment protocols, and the approval of temozolomide by regulatory bodies such as the FDA and EMA. However, challenges such as toxicity associated with extended treatment and the need for personalized medicine approaches to optimize treatment outcomes also exist[5].

Regional Market Forecast

The market forecast includes regional analyses, highlighting the global and Chinese markets as significant contributors to the overall growth. The report provides detailed forecasts for capacity, production, and production value, as well as supply and consumption trends from 2024 to 2034[2].

Competitive Landscape

The temozolomide market is characterized by a competitive landscape involving major pharmaceutical companies. The market share of key players, new projects, and strategies adopted in the past five years are crucial for understanding the market dynamics. Companies are focusing on improving manufacturing technologies and expanding their market reach through various marketing channels[2].

Market Projections

Future Growth and Opportunities

The temozolomide market is expected to continue growing, driven by ongoing clinical trials and the development of new treatment modalities. Personalized medicine approaches, such as the use of MGMT methylation status to predict treatment response, are likely to play a significant role in future treatment strategies. The integration of temozolomide with other therapies, like the Optune device, is also expected to enhance treatment outcomes[1][3].

Economic Impact

The global and Chinese macroeconomic environments will influence the temozolomide market. Factors such as economic growth, healthcare policies, and regulatory changes will impact the market's development. The report provides a detailed analysis of these factors and their potential effects on the market[2].

Key Takeaways

• Clinical Efficacy: Temozolomide has shown significant benefits in treating GBM and grade 2 gliomas, especially when combined with other therapies like radiation and the Optune device.
• Market Growth: The global temozolomide market is projected to grow at a CAGR of 2.8% from 2024 to 2034, driven by increasing incidence of brain cancers and advancements in treatment protocols.
• Regional Trends: The market is expected to see significant growth in both global and Chinese markets, with detailed forecasts provided for capacity, production, and consumption.
• Competitive Landscape: Major pharmaceutical companies are focusing on improving manufacturing technologies and expanding market reach through various strategies.
• Future Opportunities: Personalized medicine approaches and the integration of temozolomide with other therapies are expected to enhance treatment outcomes and drive market growth.

FAQs

What is the current standard treatment protocol for GBM involving temozolomide?

The current standard treatment protocol for GBM involves temozolomide combined with radiation therapy, often followed by adjuvant temozolomide. Recent trials suggest that adding the Optune device can further improve survival rates[1].

How does the duration of temozolomide treatment impact patient outcomes?

Extending temozolomide treatment from 6 months to 12 months has been shown to increase overall survival by over 50%, but it also triples the risk of toxicity[1].

What is the significance of MGMT methylation status in temozolomide treatment?

The MGMT methylation status is crucial in predicting the response to temozolomide. Patients with highly methylated MGMT have a better chance of benefiting from temozolomide, while those with low methylation do not benefit significantly[1].

How does the temozolomide market forecast look for the next decade?

The global temozolomide market is projected to grow at a CAGR of 2.8% from 2024 to 2034, driven by the increasing incidence of brain cancers and advancements in treatment protocols[5].

What are the key drivers and challenges in the temozolomide market?

Key drivers include the rising prevalence of brain cancers and regulatory approvals. Challenges include toxicity associated with extended treatment and the need for personalized medicine approaches[5].

Sources

1. Virtual Trials: Brain Tumor News Articles About Temodar or Temozolomide.
2. Prof Research: Temodar Market Size, Share, Trend and Forecast to 2029.
3. BioSpace: Recurrent Glioblastoma Market to Reach a CAGR of 5.85% during 2024-2034.
4. ECOG-ACRIN: Clinical trial finds that adding the chemotherapy pill temozolomide to radiation therapy improves survival in adult patients with a slow-growing type of brain cancer.
5. Quince Market Insights: Temozolomide Market Growth, Analysis: Trends, & Forecasts 2024-2034.