ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme (GBM)
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|ClinicalTrials.gov Identifier: NCT04587830|
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme (GBM)||Drug: ADI-PEG20 Drug: Temozolomide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1B Trial of ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme|
|Actual Study Start Date :||June 16, 2020|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||December 30, 2023|
Experimental: ADI-PEG 20 plus Radiotherapy and Temozolomide
ADI-PEG 20 Dose: 18 and 36 mg/m2 given weekly Route of Administration: Intramuscular (IM)
Radiotherapy Dose: 60 Gy in 30 daily (Monday-Friday) fractions of 2 Gy each; to start within 5 weeks of surgery (diagnostic and/or resection)
Temozolomide Dose: 75 mg/m2 daily during radiotherapy; 150-200 mg/m2 for 5 days every 4 weeks (1 cycle) x 6 cycles during maintenance period Route of Administration: oral or intravenous
Radiotherapy and TMZ are standard front-line therapy for newly diagnosed GBM.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability of ADI-PEG 20 in combination with radiotherapy and TMZ [ Time Frame: Through study completion, 2.5 year anticipated ]
- Determine recommended phase 2 dose (RP2D) [ Time Frame: Through study completion, 2.5 year anticipated ]RP2D will be determined by 3+3 method, depending on the Dose-Limiting Toxicity (DLT).
- Measure progression free survival at the RP2D [ Time Frame: Baseline brain MRI is after glioma surgery (if applicable) and prior to subject receiving the first ADI-PEG 20 administration. Scans are to be performed after 1, 3 and 6 months following completion of radiation therapy. ]Progression free survival was defined as the period of time from randomization to date of tumor progression or death. Tumor measurements must be noted and tumor response status by investigator should be calculated.
- Measure overall survival at the RP2D [ Time Frame: Through study completion, 2.5 year anticipated ]Overall Survival was defined as the period of time from randomization to date of death due to any cause.
- Minimum blood plasma concentration [Cmin ] of ADI-PEG 20 [ Time Frame: Blood samples to be collected bi-weekly for 11 weeks, then once every 4 weeks until week36. Sample will be collected prior to ADI-PEG 20 administration ]A pharmacokinetics measure of minimum ADI-PEG 20 concentration before the next ADI-PED 20 administration
- Blood plasma level of arginine and citrulline [ Time Frame: Blood samples to be collected bi-weekly for 11 weeks, then once every 4 weeks until week36. Sample will be collected prior to ADI-PEG 20 administration ]Pharmacodynamics of ADI-PEG 20 in combination with radiotherapy and TMZ
- Plasma levels of antibodies against ADI-PEG 20 [ Time Frame: Through study completion, 2.5 year anticipated ]Measurement of serum antibodies to ADI-PEG 20 to determine immunogenicity of ADI-PEG 20 in combination with radiotherapy and TMZ
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587830
|Contact: John Bomalaski, M.D.||858-452-6688 ext firstname.lastname@example.org|
|Chang Gung Memorial Hospital, Linkou Branch||Recruiting|
|Taoyuan, Taiwan, 333|
|Contact: Kuo-Chen Wei, M.D. 886-3-3281200 ext 2412 email@example.com|
|Principal Investigator: Kuo-Chen Wei, M.D.|
|Principal Investigator:||Kuo-Chen Wei, M.D.||Chang Gung Memorial Hospital|