Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04319276|
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Gallium maltolate Drug: Gallium maltolate (recommended phase 2 dose)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Clinical Trial of Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2024|
Experimental: Dose-escalation Phase
This is a 3 + 3 design. Participants will be entered sequentially. If 0 of 3 participants has a dose-limiting toxicity (DLT), new participants may be entered at the next higher dose level. If 1 of 3 participants has a DLT, up to 3 more participants are to be treated at that same dose level. If 0 of the additional 3 participants at that dose level has a DLT, new participants may be entered at the next higher dose level. If 1 or more of the additional 3 participants experience a DLT, 0 participants are to be started at that dose level and the preceding dose is the maximum-tolerated dose (MTD). If 2 of 3 of the dosed participants has a DLT on the first dose level, the drug will be administered at a lower dose. If 0 of 3 participants has a DLT at the highest dose level, an additional 3 participants will be enrolled to ensure that 6 participants are treated at the MTD. The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a DLT.
Drug: Gallium maltolate
This is a 3+3 design. The doses are as follows level -1: 250 mg daily; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily.
Other Name: CAS 108560-70-9
Experimental: Dose-expansion Phase
A minimum of six participants will be enrolled in the dose expansion phase for a total of 12 subjects at the recommended phase 2 dose.
Drug: Gallium maltolate (recommended phase 2 dose)
The maximum-tolerated dose (recommended phase 2 dose).
Other Name: CAS 108560-70-9
- Maximum-tolerated dose. [ Time Frame: Each 28-day cohort ]This will be determined from the incidence of dose limiting toxicities at each dosage.
- Progression-free survival [ Time Frame: 6 months ]This measure is the number of months participants remain free from evidence of disease. Imaging will be done every eight weeks and reported at six months.
- Overall survival [ Time Frame: 6 months ]Overall survival is determined as the average number of months subjects survived following enrollment.
- Dose-limiting toxicity [ Time Frame: 28 days for each cohort ]Number of participants experiencing a dose limiting toxicity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319276
|Contact: Medical College of Wisconsin Cancer Center Clinical Trials Officeemail@example.com|
|Principal Investigator:||Christopher Chitambar, MD||Medical College of Wisconsin|