Methods for treating cancer using PI3K inhibitor and MEK inhibitor
A cancer, dose technique, applied in for reference. , including at least one periodic field
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Embodiment 1
[0076] Example 1: Preclinical experiments
[0077] Six patient-derived colorectal cancer (CRC) xenograft models were used to study the antitumor activity and terminal Pharmacodynamic (PD) effects. The selected models contained KRAS mutations alone, KRAS and BRAF double mutations, or KRAS and PIK3CA double mutations (Table 1).
[0078] Table 1. Selected patient-derived CRC xenograft models for activity studies with compound (2) or compound (3) in combination with compound (1)
[0079]
[0080]The standard experimental design for these studies involved oral administration of Compound (2) (20 mg / kg qd), Compound (3) (75 mg / kg qd), and Compound (1) (20 mg / kg qd), except for 1 model, CR- IGR-0032-P (where a dose of 10 mg / kg qd was used)). A single dose of compound (2) or compound (3) was combined with a certain dose of compound (1) in the combination group. Once established solid tumors are staged (staging size is approximately 150-170 mm for most subcutaneous xenograft mode...
Embodiment 2
[0111] Example 2: Phase Ib Trial in Patients with Solid Tumors
[0112] A non-comparative open-label, non-randomized combination dose-escalation phase Ib trial was conducted using a classic "3+3" design in the dose-escalation cohort. In parallel with the dose escalation cohort, additional subjects may enter the lower dose level (LDL) cohort for further evaluation of safety, PK, antitumor and Pd as determined by the Safety Monitoring Committee (SMC) active. After reaching the maximum tolerated dose (MTD), the MTD population(s) will be expanded with additional subjects to confirm the MTD(s). Following confirmation of the MTD(s), additional subjects with specific tumor diagnoses will be entered into up to four disease-specific expansion cohorts as determined by the SMC.
[0113] A maximum of 90 subjects are expected to enter and receive treatment in the dose escalation and LDL / MTD cohorts of the trial. Approximately 80 additional subjects are planned to enter the four disease-...
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