Spots Global Cancer Trial Database for Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies
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Trial Identification
Brief Title: Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies
Official Title: A Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies
Study ID: NCT00629473
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mater Adult Hospital, South Brisbane, Queensland, Australia
The Queen Elizabeth Hospital, Woodville South, South Australia, Australia
Peter MacCallum Cancen Center, Melbourne, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Border Medical Oncology, Wodonga, Victoria, Australia
Sir Charles Gairdner Hospital and University of Western Australia, Nedlands, Western Australia, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Contact Details
Name: Steven D Reich, MD
Affiliation: Triphase Research and Development I Corp
Role: STUDY_DIRECTOR
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