Phase 1 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 13, 2007

Last Updated Date

November 20, 2008

Start Date ^†

March 2007

Current Primary Outcome Measures ^†

Maximum Tolerated Dose (MTD) [ Time Frame: Continous ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00461045 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

safety and toxicity profile [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
pharmacokinetics [ Time Frame: Continuous ] [ Designated as safety issue: No ]
biological activity [ Time Frame: Continuous ] [ Designated as safety issue: No ]
Recommended Phase 2 Dose [ Time Frame: Continuous ] [ Designated as safety issue: No ]
Response (EBMT criteria) [ Time Frame: Continuous ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

safety and toxicity profile
pharmacokinetics
biological activity
recommended phase 2 dose
response (EBMT criteria)

Descriptive Information

Brief Title ^†

Phase 1 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

Official Title ^†

Phase 1 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

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 relapsed or relapsed/refractory 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

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Multiple Myeloma

Intervention ^†

Drug: NPI-0052

Study Arms / Comparison Groups

Experimental: NPI-0052

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Completion Date

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Age >=18 years
Karnofsky Performance Status (KPS) >=70%
Histologic evidence of multiple myeloma, relapsed or relapsed/refractory disease for which no other approved treatment is available and clinically indicated
Adverse Events resulting from prior chemotherapy, surgery, or radiotherapy, must have resolved to acceptable grades
Adequate bone marrow, renal, adrenal, pancreatic and liver function
Hemoglobin >= 8 g/dL
Absolute neutrophil count >= 1.5 x 10^9 /L
Platelet count >= 75 x 10^9 /L (without transfusions)
Signed informed consent

Exclusion Criteria:

Administration of chemotherapy, radiation, biological, immunotherapy or investigational agent within 28 days (6 weeks for nitrosourea and 12 weeks for BMT)
Patients may be receiving steroids or bisphosphonates, but doses must be stable
Patients must be off intrathecal therapy for at least 3 months prior to dosing
Ongoing coagulopathies and/or taking anticoagulants
Patients with evidence of mucosal or internal bleeding and/or platelet refractory
Significant cardiac disease
Patients with a prior hypersensitivity reaction of CTCAE Grade >= 3 to therapy containing propylene glycol or ethanol.
Pregnant or breast-feeding women
Significant bacterial, viral or fungal infection
Any other medical conditions that would impose excessive risk to the patient

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Angie Longenecker, RN	858-200-8354	alongenecker@nereuspharm.com
Contact: Matthew A Spear, M.D., Chief Medical Officer, Nereus Pharmaceuticals

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00461045

Responsible Party

Matthew A. Spear MD, Nereus Pharmaceuticals, Inc.

Secondary IDs ^††

Study Sponsor ^†

Nereus Pharmaceuticals, Inc.

Collaborators ^††

Investigators ^†

Study Director:

Alison Hannah, MD

Nereus Pharmaceuticals

Information Provided By

Nereus Pharmaceuticals, Inc.

Verification Date

November 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.