Status:
COMPLETED
NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma
Lead Sponsor:
Celgene
Conditions:
Non-Small Cell Lung Cancer
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a clinical trial examining the safety, pharmacokinetics, pharmacodynamics and efficacy of IV NPI-0052 (a proteasome inhibitor) in combination with oral vorinostat (Zolinza; a HDAC inhibitor) i...
Eligibility Criteria
Inclusion
- Karnofsky Performance Status (KPS) at 70% or more.
- Non-small cell lung cancer, pancreatic adenocarcinoma, melanoma or lymphoma for which a standard, approved therapy is not available. Patients must have lesions that are evaluable by RECIST criteria.
- All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to CTCAE (v. 3.0) Grade 1 or less(except for hemoglobin).
- Adequate bone marrow, renal, liver function.
- Signed informed consent.
Exclusion
- Recent administration of chemotherapy, biological, immunotherapy or investigational agent, major surgery, or radiotherapy.
- Intrathecal therapy.
- Known brain metastases.
- Significant cardiac disease.
- Prior treatment with vorinostat or NPI-0052, or other HDACi (including valproic acid) or proteasome inhibitors.
- Known allergy to any component of vorinostat. Prior hypersensitivity reaction of CTCAE Grade \> 3 to therapy containing propylene glycol or ethanol.
- Pregnant or breast-feeding women.
- Concurrent, active secondary malignancy for which the patient is receiving therapy.
- Significant active infection.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00667082
Start Date
March 1 2008
End Date
January 1 2010
Last Update
November 22 2017
Active Locations (3)
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1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
2
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
3
Sir Charles Gairdner Hospital and University of Western Australia
Nedlands, Western Australia, Australia, 6009