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Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies

NCT00629473 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2017-11-22

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Steven D Reich, MD · Triphase Research and Development I Corp

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00629473 on ClinicalTrials.gov