temozolomide
Clinical Trials Overview
15 trials found
About temozolomide
Temozolomide is an oral alkylating chemotherapy agent used off-label in colorectal cancer, particularly in tumors with MGMT methylation or mismatch repair deficiency. This DNA-damaging agent is primarily FDA-approved for brain tumors but has shown activity in CRC patients whose tumors have specific molecular characteristics that make them more susceptible to alkylating damage. In colorectal cancer, temozolomide is often combined with other agents like capecitabine or radiation therapy, especially in locally advanced rectal cancer with MGMT silencing.
Category
Other Medications
Brand Name
Temodar
Mechanism
Temozolomide spontaneously converts to its active metabolite MTIC (methyl-triazeno-imidazole-carboxamide), which methylates DNA at the O6 position of guanine residues, leading to DNA strand breaks and cell death. Tumors with methylated MGMT (O6-methylguanine-DNA methyltransferase) promoter are particularly sensitive because they cannot efficiently repair this DNA damage.
15
Total Trials
6
Recruiting
1
Active
7
Completed
2,687
Total Enrollment
18
Countries
Research trend for temozolomide
Number of trials started per year
Research has declined since peaking at 2 trials in 2019.
Active sites for temozolomide
Recruiting sites
18 countries
Phase:
NCT06490536
Phase 3
Recruiting
700 patients
Medications:
5-Fluorouracil
Capecitabine
Ipilimumab
Irinotecan
Leucovorin
Nivolumab
Oxaliplatin
Panitumumab
Pertuzumab
Temozolomide
Trastuzumab
Background \& Rationale:
Colon cancer is a leading cause of cancer deaths, with a high recurrence rate in stage II high-risk and stage III patients due to undetectable micro-metastases. Liquid biopsy (LB) detects residual cancer DNA post-surgery and...
Germany, Italy, Spain
NCT05691491
Phase 1
Recruiting
42 patients
Medications:
Temozolomide
Tuvusertib
This phase I/II trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and ma...
United States
NCT05417594
Phase 1
Recruiting
695 patients
This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in participants with advanced cancer that has recurred/progress...
United States, Australia, Germany, South Korea, Spain, Sweden, United Kingdom
NCT05136326
Phase 2
Recruiting
21 patients
Medications:
Capecitabine
Temozolomide
In patients with locally advanced rectal cancer (LARC), preoperative chemo-radiotherapy (CTRT) is considered the standard of care. Preoperative CTRT approach often results in a significant tumor downstaging and local control, with evidence of complet...
Italy
NCT04689347
Phase 1
Recruiting
27 patients
An upfront-intensified treatment combining all the three active cytotoxic agents in metastatic colorectal cancer (mCRC) including fluoropyrimidines, oxaliplatin, irinotecan (FOLFOXIRI) plus antiangiogenic blockade with bevacizumab significantly impro...
Italy
NCT03715933
Phase 1
Recruiting
411 patients
Medications:
5-Fluorouracil
Bevacizumab
Carboplatin
INBRX-109
Irinotecan
Leucovorin
Pemetrexed
Temozolomide
Tipiracil
Trifluridine
This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).
United States, France, Italy, Netherlands, Spain, United Kingdom
NCT04457284
Phase 2
Active
18 patients
This study will test whether the combination of cisplatin, nivolumab, and temozolomide is an effective treatment for in people with advanced and/or metastatic colorectal cancer that is mismatch repair-proficient (MMR-proficient). The researchers will...
United States
NCT07492680
Phase 2
Not yet recruiting
260 patients
Medications:
BMS-986504
Carboplatin
Daraxonrasib
Gemcitabine
Nab-Paclitaxel
Nivolumab
Paclitaxel
Pemetrexed
Pumitamig
Temozolomide
This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is...
United States, Belgium, Canada, China, France, Germany, Hong Kong, Ireland, Italy, Japan, Norway, So
NCT04166435
Phase 2
Completed
11 patients
Medications:
Olaparib
Temozolomide
This is a Phase II, non-randomized, open-label study to evaluate temozolomide in combination with olaparib in patients with MGMT promoter hypermethylated advanced colorectal cancer.
United States
NCT03832621
Phase 2
Completed
135 patients
This is a Phase II, multicenter, single-arm trial designed to evaluate the efficacy and safety of nivolumab (NIVO), ipilimumab (IPI) and temozolomide (TMZ) combination in 27 patients with MSS, MGMT-silenced mCRC with initial clinical benefit followin...
Italy
NCT03519412
Phase 2
Completed
102 patients
Medications:
Pembrolizumab
Temozolomide
In this study, MMRd metastatic colorectal cancer (mCRC) patients who failed standard therapies will undergo treatment with pembrolizumab, while RAS-extended mutated MMR-proficient mCRC patients will be tested for o6-methylguanine-DNA-methyltransferas...
Italy
NCT02414009
Phase 2
Completed
82 patients
Open-label, randomized, multicenter, Phase II trial designed to estimate the efficacy of CAPTEM versus FOLFIRI as second line treatment in MGMT methylated, RAS mutated advanced CRC patients who have progressed on or after first-line oxaliplatin conta...
Italy
NCT01781403
Phase 1
Completed
22 patients
Medications:
Temozolomide
The investigators planned a phase I study of preoperative CRT with capecitabine plus temozolomide inpatients with locally advanced resectable rectal cancer: 1) the role of temozolomide as a radiosensitizer has been well established, 2) hypermethylati...
South Korea
NCT01051596
Phase 2
Completed
75 patients
Medications:
Temozolomide
Veliparib
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 c...
United States
NCT00423150
Phase 2
Completed
86 patients
Medications:
Temozolomide
This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker. Participants with colorectal cancer, non-small-cell lung cancer, head and neck cancer, or eso...