A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
A Phase 3 Randomized, Open-label, Multicenter Clinical Study of CGT9486+Sunitinib vs Sunitinib in Subjects with Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
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Clinical Trial Information
Trial Contact: Frankos, Marie; Caldwell, Chloe M; Donaldson, Karin M; Grofsik, Kiera
Trial Phone: 321.841.7303 ; (321)841.1107 ; 321.841.9821 ; 321.841.6626
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IRB No: W22.017.01
Protocol Abbrev: CGT9486-21-301
Principal Investigator: Sajeve Samuel Thomas, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: PEAK
Treatment: CGT9486 (formerly PLX9486) Sunitinib
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT05208047
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Objective
Primary
To confirm the dose of a modified CGT9486 formulation to have a similar target exposure to that previously studied in subjects with GIST
Secondary
To characterize the safety of CGT9486+sunitinib in subjects with GIST
To evaluate efficacy parameters of CGT9486+sunitinib in subjects with GIST
To explore various pharmacodynamic markers and their relationship with clinical safety, efficacy, and PK
Exploratory
To determine the effects of CGT9486+sunitinib on KIT exon mutations -
Key Eligibility
To be eligible for enrollment in the study, subjects must be at least 18 years of age, have locally advanced, metastatic, and/or unresectable GIST, and have received prior therapy with imatinib. In Part 1a, subjects may have received any number of prior lines of therapy; in Part 1b, subjects must have received at least 2 prior lines of therapy; in Part 2, subjects may not have received any TKI other than imatinib. Subjects must have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits, including absolute neutrophil count ≥1×109/L, platelet count ≥ 100×109/L, aspartate aminotransferase and alanine aminotransferase ≤2.5×upper limit of normal (ULN) or ≤5×ULN in the presence of hepatic metastases, and total and direct bilirubin ≤1.5×ULN or for subjects with confirmed Gilbert’s syndrome, direct bilirubin ≤1.5×ULN and indirect bilirubin ≤3×ULN, and estimated glomerular filtration rate ≥45 mL/min/1.73 m2. Subjects must not have clinically significant cardiac disease, gastrointestinal abnormalities, or expect to need treatment for an active malignancy other than the disease under study.
