Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, Wi… (NCT02481154) | Clinical Trial Compass
CompletedPhase 1
Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation
United States95 participantsStarted 2015-06
Plain-language summary
This study evaluates the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-881 in Gliomas, that harbor an IDH1 and/or IDH2 mutation.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patient must be ≥18 years of age
* Patient must have histologically or cytologically confirmed solid tumor, including glioma, with documented IDH1 and/or IDH2 gene-mutation. Patients in the dose escalation phase must have disease that has recurred or progressed following standard therapy and/or therapy with an inhibitor of mutant IDH1 and/or IDH2, or that has not responded to this therapy. Patients in the expansion phase may have previously untreated disease
* Patient must have evaluable disease by RECIST v1.1 for patients without glioma or by RANO or RANO LGG criteria for patients with glioma
* Patients with glioma must have a baseline brain MRI scan
* Patient must have archived primary tumor biopsies or surgical specimens, or biopsies of recurrent or metastatic samples
* Patient must be amenable to serial peripheral blood sampling, urine sampling, and tumor biopsies during the study
* Patient must be able to understand and willing to sign an informed consent
* Patient must have ECOG PS of 0 to 2
* Patient must have expected survival of ≥3 months
* Patient must have adequate bone marrow function as evidenced by absolute neutrophil count ≥1.5 ×10\^9/L; hemoglobin \>9 g/dL (Patients are allowed to be transfused to this level); platelets ≥75 × 10\^9/L
* Patient must have adequate hepatic function as evidenced by: Serum total bilirubin ≤1.5 × upper limit of normal (ULN), unless considered due to Gilbert's disease or disease involvement; Aspartate aminotran…
What they're measuring
1
Safety/Tolerability; incidence of adverse events
Timeframe: Up to 26 weeks, on average
2
Maximum Tolerated Dose and/or the recommended Phase II dose of AG881 in patients with advance solid tumors, including gliomas
Timeframe: Up to 26 weeks, on average
Trial details
NCT IDNCT02481154
SponsorInstitut de Recherches Internationales Servier