NCT00629473|CompletedPhase 1
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
Loading search results
A Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies
Sponsor study identifier
interventional
86
1 country
7
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
February 26, 2008
Actual (reported)March 6, 2008
Actual (reported)April 2013
Actual (reported)April 2013
Actual (reported)Determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of NPI-0052
Assess dose-limiting toxicities during Cycle 1 for each treatment arm
Cycle 1 (Arm AM: 28-days, Arm MM: 21-days)
To evaluate the pharmacokinetics activity of NPI-0052
Baseline, Days 1 and 15 (before injection and 1 hour post injection) of Cycle 1
To evaluate the safety and tolerability of NPI-0052
Treatment period through 28-days after the last dose of study drug
To evaluate the pharmacodynamics of NPI-0052
Baseline, Days 1 and 15 (before injection and 1 hour post injection) of Cycles 1 and 2 and of every other cycle thereafter through study completion
Dose Escalation - 9 dose cohorts NPI-0052 on Days 1, 8, 15 every 28 days NPI-0052 doses ranging from 0.1 to 0.9 mg/m2
Dose Escalation - 8 dose cohorts NPI-0052 on Days 1, 4, 8, 11 every 21 days NPI-0052 doses ranging from 0.075 to 0.6 mg/m2 Dexamethasone 20 mg oral or IV day before and day after NPI-0052 dosing.
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
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
Mater Adult Hospital
South Brisbane, Queensland, 4101, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5001, Australia
Peter MacCallum Cancen Center
Melbourne, Victoria, 3002, Australia
The Alfred Hospital
Melbourne, Victoria, 3168, Australia
Border Medical Oncology
Wodonga, Victoria, 3690, Australia
Sir Charles Gairdner Hospital and University of Western Australia
Nedlands, Western Australia, 6009, Australia
Royal Perth Hospital
Perth, Western Australia, 6001, Australia
Steven D Reich, MD
Triphase Research and Development I Corp
86 participants (actual enrollment reported by the registry).
First Submitted
February 26, 2008
First Posted
March 6, 2008
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Valproic Acid and Bevacizumab in Patients With Advanced Cancer
20 mg oral or IV day before and day after NPI-0052 dosing.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)Last Updated
November 22, 2017
Record last verified: 2017-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: