Back to resultsNPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma
Primary Purpose
Non-Small Cell Lung Cancer, Pancreatic Cancer, Melanoma
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
NPI-0052 (marizomib) + vorinostat
Sponsored by
About this trial
This is an interventional other trial for Non-Small Cell Lung Cancer focused on measuring Non small Cell Lung Cancer, Pancreatic Cancer, Melanoma, Lymphoma, Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Royal Adelaide Hospital
- The Queen Elizabeth Hospital
- Sir Charles Gairdner Hospital and University of Western Australia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NPI-0052 + Vorinostat Dose-Escalation
Arm Description
4 dose-escalation cohorts
Outcomes
Primary Outcome Measures
To determine the Maximum tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the combination NPI-0052 and Vorinostat
Secondary Outcome Measures
To evaluate the pharmacokinetics and pharmacodynamics of NPI-0052 and vorinostat
To evaluate the safety and toxicity profile of the combination of NPI-0052 and vorinostat
To evaluate the anti-tumor activity of NPI-0052 and vorinostat
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00667082
Brief Title
NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma
Official Title
NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
No
5. Study Description
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) in patients with non-small cell lung cancer, pancreatic cancer, melanoma or lymphoma. Proteasome inhibitors block the breakdown of proteins by cells and HDAC inhibitors block modification of proteins regulating gene expression in cells. Both of these actions preferentially affect cancer cells, and the combination of the two has been seen to have a greater effect in laboratory studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer, Pancreatic Cancer, Melanoma, Lymphoma, Multiple Myeloma
Keywords
Non small Cell Lung Cancer, Pancreatic Cancer, Melanoma, Lymphoma, Multiple Myeloma
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NPI-0052 + Vorinostat Dose-Escalation
Arm Type
Experimental
Arm Description
4 dose-escalation cohorts
Intervention Type
Drug
Intervention Name(s)
NPI-0052 (marizomib) + vorinostat
Other Intervention Name(s)
marizomib, proteasome inhibitor, HDAC inhibitor, Zolinza
Intervention Description
NPI-0052 IV injection over 1 to 10 minutes at doses ranging from 0.15 to 0.7 mg/m2 on Days 1, 8, and 15 of each 28-day Cycle
Oral vorinostat 300 mg was administered with food on Days 1 to 16 of each 28-day Cycle
Primary Outcome Measure Information:
Title
To determine the Maximum tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the combination NPI-0052 and Vorinostat
Time Frame
continuously
Secondary Outcome Measure Information:
Title
To evaluate the pharmacokinetics and pharmacodynamics of NPI-0052 and vorinostat
Time Frame
continuous
Title
To evaluate the safety and toxicity profile of the combination of NPI-0052 and vorinostat
Time Frame
continuous
Title
To evaluate the anti-tumor activity of NPI-0052 and vorinostat
Time Frame
continuous
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven D Reich, MD
Organizational Affiliation
Triphase Research and Development I Corp
Official's Role
Study Director
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Sir Charles Gairdner Hospital and University of Western Australia
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma
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