Status:
COMPLETED
Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies
Lead Sponsor:
Celgene
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 advanced malignancies including s...
Detailed Description
Patients were enrolled in 1 of 2 study arms. Arm AM (weekly doses of NPI-0052) consisted of patients with solid and hematological malignancies excluding multiple myeloma (MM), and these patients recei...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Karnofsky Performance Status (KPS) \> 70%.
- Histologically-confirmed advanced malignancy for which a standard, approved therapy is not available.
- Adequate renal, liver, pancreatic and hematologic function
- Signed informed consent (sample IC form is provided in Appendix A).
- Exclusion Criteria
- Administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days
- Patients that require G-CSF and/or platelet support during screening and are likely to require G-CSF and/or platelet support for the duration of the clinical trial.
- Patients with ongoing coagulopathies and/or taking anticoagulants
- Patients receiving intrathecal therapy.
- Known brain metastases.
- Pre-existing adrenal insufficiency; concomitant therapy with replacement corticosteroids. Pre-existing acute or chronic pancreatitis.
- Significant cardiac disease.
- Pregnant or breast-feeding women.
- Concurrent, active secondary malignancy for which the patient is receiving therapy. (Lymphoma patients with a diagnosis of a potentially hormone-sensitive tumor who are without evidence of disease for this second malignancy may continue to receive hormonal therapy).
- Patients with proteinuria Grade 2 or greater
- Active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics.
- Patients who are known to be HIV positive or have active Hepatitis A, B, or C infection.
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00629473
Start Date
July 1 2007
End Date
April 1 2013
Last Update
November 22 2017
Active Locations (7)
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1
Mater Adult Hospital
South Brisbane, Queensland, Australia, 4101
2
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5001
3
Peter MacCallum Cancen Center
Melbourne, Victoria, Australia, 3002
4
The Alfred Hospital
Melbourne, Victoria, Australia, 3168