Trials / Completed
CompletedNCT00629473
Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies
A Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NPI-0052 on Days 1, 8, 15 every 28 days | NPI-0052 dose ranging from 0.1 to 0.9 mg/m2 NPI-0052 IV injection over 1 to 120 minutes on Days 1, 8, and 15 of 4-week cycles |
| DRUG | NPI-0052 on Days 1, 4, 8, 11 every 21 days | NPI-0052 dose ranging from 0.075 to 0.6 mg/m2 NPI-0052 IV injection over 1 to 120 minutes on Days 1, 4, 8, and 11 of 3-week cycles |
| DRUG | Dexamethasone | 20 mg oral or IV day before and day after NPI-0052 dosing. |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2013-04-01
- Completion
- 2013-04-01
- First posted
- 2008-03-06
- Last updated
- 2017-11-22
Locations
7 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT00629473. Inclusion in this directory is not an endorsement.