Status:
COMPLETED
Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Solid Tumor Malignancies or Refractory Lymphoma
Lead Sponsor:
Celgene
Conditions:
Cancer
Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Detailed Description
NPI-0052 (also known as marizomab) is a second generation proteasome inhibitor being developed as an anticancer agent. Proteasomes are responsible for degrading substrates such as damaged and aged pro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00396864
Start Date
May 1 2006
End Date
March 1 2010
Last Update
November 22 2017
Active Locations (3)
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1
Premiere Oncology of America
Scottsdale, Arizona, United States, 85260
2
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
3
Univ. of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030