NCT00396864

Brief Summary

Multicenter, open-label study of NPI-0052 in patients with advanced solid tumor malignancies or refractory lymphoma whose disease had progressed after treatment with standard, approved therapies that included 2 stages. The initial stage involved dose escalation to an MTD and determination of a recommended Phase 2 dose. The second stage comprised an expansion cohort at the recommended Phase 2 dose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1 cancer

Timeline
Completed

Started May 2006

Typical duration for phase_1 cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

November 22, 2017

Status Verified

November 1, 2017

Enrollment Period

3.8 years

First QC Date

November 6, 2006

Last Update Submit

November 20, 2017

Conditions

CancerLymphomas

Keywords

cutaneous lymphomamarginal zone lymphoma

Outcome Measures

Primary Outcomes (3)

  • Safety

    Continuous

  • Maximum Tolerated Dose (MTD)

    Continuous

  • Pharmacokinetics

    Continuous

Secondary Outcomes (2)

  • Pharmacodynamics

    Continuous

  • Response

    Continous

Study Arms (1)

NPI-0052

EXPERIMENTAL

Advanced Solid Tumor Malignancies and Refractory Lymphoma

Drug: NPI-0052

Interventions

NPI-0052DRUG

NPI-0052 IV injection at doses ranging from 0.0125 to 0.8 mg/m2 over 1 to 10 minutes on Day 1, Day 8, Day 15 of each 28-day Cycle; 11 dose cohorts during dose-escalation

Also known as: Marizomib, MRZ
NPI-0052

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically-confirmed solid tumor malignancy (patients must be refractory to or demonstrate unacceptable toxicity towards effective therapy known to provide clinical benefit for their condition) OR refractory lymphoma (patients whose disease has progressed despite standard therapy including at least one-doxorubicin-containing regimen and one anti-CD20 monoclonal antibody-containing regimen.
  • KPS ≥70%.
  • All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to NCI CTCAE (v. 3.0) Grade ≤ 1 (except for hemoglobin).
  • Adequate bone marrow, renal, adrenal, pancreatic and liver function.
  • Signed informed consent.

You may not qualify if:

  • Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days prior to receipt of study medication (6 weeks for nitrosoureas or mitomycin C; 12 weeks for radioimmunotherapy). Major surgery, other than diagnostic surgery, within 4 weeks before first study drug administration. Radiotherapy within 4 weeks.
  • Patients that require G-CSF and/or platelet support.
  • Patients with ongoing coagulopathies.
  • Patients with prior bone marrow transplant therapy (autologous or allogeneic).
  • Patients receiving intrathecal therapy.
  • Known brain metastases.
  • 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. Female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control. Female patients with childbearing potential must have a negative serum pregnancy test. Male patients must be surgically sterile or agree to use an acceptable method of contraception.
  • Concurrent, active secondary malignancy for which the patient is receiving therapy.
  • Active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics.
  • Known to be positive for HIV; active hepatitis A, B, or C infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Premiere Oncology of America

Scottsdale, Arizona, 85260, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Univ. of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

NeoplasmsLymphomaLymphoma, T-Cell, CutaneousLymphoma, B-Cell, Marginal Zone

Interventions

marizomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-HodgkinLymphoma, B-Cell

Study Officials

  • Steven D Reich, MD

    Triphase Research and Development I Corp

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2006

First Posted

November 8, 2006

Study Start

May 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

November 22, 2017

Record last verified: 2017-11

Locations

US(3)