Advanced Cancer Clinical Trial
Official title:
A Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies
This is a Phase 1 clinical trial examining the safety, pharmacokinetics and pharmacodynamics of escalating doses of the proteasome inhibitor NPI-0052 in patients with advanced malignancies including solid tumors, lymphomas, leukemias and multiple myeloma. By inhibiting proteasomes NPI-0052 prevents the breakdown of proteins involved in signal transduction, which blocks growth and survival in cancer cells.
Patients were enrolled in 1 of 2 study arms. Arm AM (weekly doses of NPI-0052) consisted of
patients with solid and hematological malignancies excluding multiple myeloma (MM), and these
patients received NPI-0051 once weekly for 3 weeks of every 4 weeks. Arm MM (twice-weekly
doses of NPI-0052) consisted of patients with MM and other hematological malignancies, and
these patients received NPI-0052 twice weekly for 2 weeks of every 3 weeks. All patients
received NPI-0052 administered IV over approximately 1 to 120 minutes. Patients with MM (Arm
MM) also received 20 mg dexamethasone per orally or IV on the day before and the day of
NPI-0052 dosing.
Patients were initially enrolled in dose-escalating cohorts to determine the maximum
tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of NPI-0052. Once the RP2D was
determined for each arm of the study, the RP2D was evaluated in the dose-expansion stage of
the study.
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